Sample records for classification class ii

  1. Modified Angle's Classification for Primary Dentition.

    PubMed

    Chandranee, Kaushik Narendra; Chandranee, Narendra Jayantilal; Nagpal, Devendra; Lamba, Gagandeep; Choudhari, Purva; Hotwani, Kavita

    2017-01-01

    This study aims to propose a modification of Angle's classification for primary dentition and to assess its applicability in children from Central India, Nagpur. Modification in Angle's classification has been proposed for application in primary dentition. Small roman numbers i/ii/iii are used for primary dentition notation to represent Angle's Class I/II/III molar relationships as in permanent dentition, respectively. To assess applicability of modified Angle's classification a cross-sectional preschool 2000 children population from central India; 3-6 years of age residing in Nagpur metropolitan city of Maharashtra state were selected randomly as per the inclusion and exclusion criteria. Majority 93.35% children were found to have bilateral Class i followed by 2.5% bilateral Class ii and 0.2% bilateral half cusp Class iii molar relationships as per the modified Angle's classification for primary dentition. About 3.75% children had various combinations of Class ii relationships and 0.2% children were having Class iii subdivision relationship. Modification of Angle's classification for application in primary dentition has been proposed. A cross-sectional investigation using new classification revealed various 6.25% Class ii and 0.4% Class iii molar relationships cases in preschool children population in a metropolitan city of Nagpur. Application of the modified Angle's classification to other population groups is warranted to validate its routine application in clinical pediatric dentistry.

  2. Di-codon Usage for Gene Classification

    NASA Astrophysics Data System (ADS)

    Nguyen, Minh N.; Ma, Jianmin; Fogel, Gary B.; Rajapakse, Jagath C.

    Classification of genes into biologically related groups facilitates inference of their functions. Codon usage bias has been described previously as a potential feature for gene classification. In this paper, we demonstrate that di-codon usage can further improve classification of genes. By using both codon and di-codon features, we achieve near perfect accuracies for the classification of HLA molecules into major classes and sub-classes. The method is illustrated on 1,841 HLA sequences which are classified into two major classes, HLA-I and HLA-II. Major classes are further classified into sub-groups. A binary SVM using di-codon usage patterns achieved 99.95% accuracy in the classification of HLA genes into major HLA classes; and multi-class SVM achieved accuracy rates of 99.82% and 99.03% for sub-class classification of HLA-I and HLA-II genes, respectively. Furthermore, by combining codon and di-codon usages, the prediction accuracies reached 100%, 99.82%, and 99.84% for HLA major class classification, and for sub-class classification of HLA-I and HLA-II genes, respectively.

  3. Modified Angle's Classification for Primary Dentition

    PubMed Central

    Chandranee, Kaushik Narendra; Chandranee, Narendra Jayantilal; Nagpal, Devendra; Lamba, Gagandeep; Choudhari, Purva; Hotwani, Kavita

    2017-01-01

    Aim: This study aims to propose a modification of Angle's classification for primary dentition and to assess its applicability in children from Central India, Nagpur. Methods: Modification in Angle's classification has been proposed for application in primary dentition. Small roman numbers i/ii/iii are used for primary dentition notation to represent Angle's Class I/II/III molar relationships as in permanent dentition, respectively. To assess applicability of modified Angle's classification a cross-sectional preschool 2000 children population from central India; 3–6 years of age residing in Nagpur metropolitan city of Maharashtra state were selected randomly as per the inclusion and exclusion criteria. Results: Majority 93.35% children were found to have bilateral Class i followed by 2.5% bilateral Class ii and 0.2% bilateral half cusp Class iii molar relationships as per the modified Angle's classification for primary dentition. About 3.75% children had various combinations of Class ii relationships and 0.2% children were having Class iii subdivision relationship. Conclusions: Modification of Angle's classification for application in primary dentition has been proposed. A cross-sectional investigation using new classification revealed various 6.25% Class ii and 0.4% Class iii molar relationships cases in preschool children population in a metropolitan city of Nagpur. Application of the modified Angle's classification to other population groups is warranted to validate its routine application in clinical pediatric dentistry. PMID:29326514

  4. Thematic accuracy of the National Land Cover Database (NLCD) 2001 land cover for Alaska

    USGS Publications Warehouse

    Selkowitz, D.J.; Stehman, S.V.

    2011-01-01

    The National Land Cover Database (NLCD) 2001 Alaska land cover classification is the first 30-m resolution land cover product available covering the entire state of Alaska. The accuracy assessment of the NLCD 2001 Alaska land cover classification employed a geographically stratified three-stage sampling design to select the reference sample of pixels. Reference land cover class labels were determined via fixed wing aircraft, as the high resolution imagery used for determining the reference land cover classification in the conterminous U.S. was not available for most of Alaska. Overall thematic accuracy for the Alaska NLCD was 76.2% (s.e. 2.8%) at Level II (12 classes evaluated) and 83.9% (s.e. 2.1%) at Level I (6 classes evaluated) when agreement was defined as a match between the map class and either the primary or alternate reference class label. When agreement was defined as a match between the map class and primary reference label only, overall accuracy was 59.4% at Level II and 69.3% at Level I. The majority of classification errors occurred at Level I of the classification hierarchy (i.e., misclassifications were generally to a different Level I class, not to a Level II class within the same Level I class). Classification accuracy was higher for more abundant land cover classes and for pixels located in the interior of homogeneous land cover patches. ?? 2011.

  5. 21 CFR 880.5440 - Intravascular administration set.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

  6. 21 CFR 880.5440 - Intravascular administration set.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

  7. 21 CFR 880.5440 - Intravascular administration set.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

  8. 21 CFR 880.5440 - Intravascular administration set.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified...

  9. 76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... intended for non-invasive aesthetic use will need to address the issues covered in the special controls... intended for non-invasive aesthetic use. (b) Classification. Class II (special controls). The special... into class II (special controls). The special control that will apply to the device is the guidance...

  10. [Preoperative risk assessment with the ASA classification. A prospective study of morbidity and mortality in various ASA classes in 2,937 patients in general surgery].

    PubMed

    Menke, H; John, K D; Klein, A; Lorenz, W; Junginger, T

    1992-12-01

    The value of ASA classification in assessment of perioperative risk, i.e. especially postoperative morbidity, was analyzed prospectively using the data of 2937 patients. The analysis took into account the criteria validity, reliability, and sensitivity. The incidence of post-operative morbidity after elective surgery rose from 3.9% in ASA class I to 36% in ASA class IV. Mortality was 0.6% in ASA class II, whereas 9.3% died in ASA class IV. Morbidity, mortality respectively, after emergency surgery was 10.2% in ASA class II compared to 69% in class IV, mortality 1.4% compared to 21.5%. Differences between the ASA classes were confirmed (p-value < 0.05) considering separate kinds of complications and different periods. Furthermore, ASA classification was a valuable reference to length of stay and severity of necessary therapy at the ICU.

  11. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...

  12. 78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to... controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval...

  13. 76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

  14. 78 FR 37998 - Electronic One Touch Bingo System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... decision regarding the classification of server based electronic bingo system games that can be played... Class II or Class III game. DATES: The agency must receive comments on or before August 26, 2013... from the regulated community regarding the status of one touch bingo as a Class II or a Class III game...

  15. Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting.

    PubMed

    Deck, Daniel H; Jordan, Jennifer M; Holland, Thomas L; Fan, Weihong; Wikler, Matthew A; Sulham, Katherine A; Ralph Corey, G

    2016-09-01

    Introduction of new antibiotics enabling single-dose administration, such as oritavancin may significantly impact site of care decisions for patients with acute bacterial skin and skin structure infections (ABSSSI). This analysis compared the efficacy of single-dose oritavancin with multiple-dose vancomycin in patients categorized according to disease severity via modified Eron classification and management setting. SOLO I and II were phase 3 studies evaluating single-dose oritavancin versus 7-10 days of vancomycin for treatment of ABSSSI. Patient characteristics were collected at baseline and retrospectively analyzed. Study protocols were amended, allowing outpatient management at the discretion of investigators. In this post hoc analysis, patients were categorized according to a modified Eron severity classification and management setting (outpatient vs. inpatient) and the efficacy compared. Overall, 1910 patients in the SOLO trials were categorized into Class I (520, 26.5%), II (790, 40.3%), and III (600, 30.6%). Of the 767 patients (40%) in the SOLO trials who were managed entirely in the outpatient setting 40.3% were categorized as Class II and 30.6% were Class III. Clinical efficacy was similar between oritavancin and vancomycin treatment groups, regardless of severity classification and across inpatient and outpatient settings. Class III patients had lower response rates (oritavancin 73.3%, vancomycin 76.6%) at early clinical evaluation when compared to patients in Class I (82.6%) or II (86.1%); however, clinical cure rates at the post-therapy evaluation were similar for Class III patients (oritavancin 79.8%, vancomycin 79.9%) when compared to Class I and II patients (79.1-85.7%). Single-dose oritavancin therapy results in efficacy comparable to multiple-dose vancomycin in patients categorized according to modified Eron disease severity classification regardless of whether management occurred in the inpatient or outpatient setting. The Medicines Company, Parsippany, NJ, USA. ClinicalTrials.gov identifiers, NCT01252719 (SOLO I) and NCT01252732 (SOLO II).

  16. Digital classification of Landsat data for vegetation and land-cover mapping in the Blackfoot River watershed, southeastern Idaho

    USGS Publications Warehouse

    Pettinger, L.R.

    1982-01-01

    This paper documents the procedures, results, and final products of a digital analysis of Landsat data used to produce a vegetation and landcover map of the Blackfoot River watershed in southeastern Idaho. Resource classes were identified at two levels of detail: generalized Level I classes (for example, forest land and wetland) and detailed Levels II and III classes (for example, conifer forest, aspen, wet meadow, and riparian hardwoods). Training set statistics were derived using a modified clustering approach. Environmental stratification that separated uplands from lowlands improved discrimination between resource classes having similar spectral signatures. Digital classification was performed using a maximum likelihood algorithm. Classification accuracy was determined on a single-pixel basis from a random sample of 25-pixel blocks. These blocks were transferred to small-scale color-infrared aerial photographs, and the image area corresponding to each pixel was interpreted. Classification accuracy, expressed as percent agreement of digital classification and photo-interpretation results, was 83.0:t 2.1 percent (0.95 probability level) for generalized (Level I) classes and 52.2:t 2.8 percent (0.95 probability level) for detailed (Levels II and III) classes. After the classified images were geometrically corrected, two types of maps were produced of Level I and Levels II and III resource classes: color-coded maps at a 1:250,000 scale, and flatbed-plotter overlays at a 1:24,000 scale. The overlays are more useful because of their larger scale, familiar format to users, and compatibility with other types of topographic and thematic maps of the same scale.

  17. Random forest wetland classification using ALOS-2 L-band, RADARSAT-2 C-band, and TerraSAR-X imagery

    NASA Astrophysics Data System (ADS)

    Mahdianpari, Masoud; Salehi, Bahram; Mohammadimanesh, Fariba; Motagh, Mahdi

    2017-08-01

    Wetlands are important ecosystems around the world, although they are degraded due both to anthropogenic and natural process. Newfoundland is among the richest Canadian province in terms of different wetland classes. Herbaceous wetlands cover extensive areas of the Avalon Peninsula, which are the habitat of a number of animal and plant species. In this study, a novel hierarchical object-based Random Forest (RF) classification approach is proposed for discriminating between different wetland classes in a sub-region located in the north eastern portion of the Avalon Peninsula. Particularly, multi-polarization and multi-frequency SAR data, including X-band TerraSAR-X single polarized (HH), L-band ALOS-2 dual polarized (HH/HV), and C-band RADARSAT-2 fully polarized images, were applied in different classification levels. First, a SAR backscatter analysis of different land cover types was performed by training data and used in Level-I classification to separate water from non-water classes. This was followed by Level-II classification, wherein the water class was further divided into shallow- and deep-water classes, and the non-water class was partitioned into herbaceous and non-herbaceous classes. In Level-III classification, the herbaceous class was further divided into bog, fen, and marsh classes, while the non-herbaceous class was subsequently partitioned into urban, upland, and swamp classes. In Level-II and -III classifications, different polarimetric decomposition approaches, including Cloude-Pottier, Freeman-Durden, Yamaguchi decompositions, and Kennaugh matrix elements were extracted to aid the RF classifier. The overall accuracy and kappa coefficient were determined in each classification level for evaluating the classification results. The importance of input features was also determined using the variable importance obtained by RF. It was found that the Kennaugh matrix elements, Yamaguchi, and Freeman-Durden decompositions were the most important parameters for wetland classification in this study. Using this new hierarchical RF classification approach, an overall accuracy of up to 94% was obtained for classifying different land cover types in the study area.

  18. Statewide land cover derived from multiseasonal Landsat TM data: A retrospective of the WISCLAND project

    USGS Publications Warehouse

    Reese, H.M.; Lillesand, T.M.; Nagel, D.E.; Stewart, J.S.; Goldmann, R.A.; Simmons, T.E.; Chipman, J.W.; Tessar, P.A.

    2002-01-01

    Landsat Thematic Mapper (TM) data were the basis in production of a statewide land cover data set for Wisconsin, undertaken in partnership with U.S. Geological Survey's (USGS) Gap Analysis Program (GAP). The data set contained seven classes comparable to Anderson Level I and 24 classes comparable to Anderson Level II/III. Twelve scenes of dual-date TM data were processed with methods that included principal components analysis, stratification into spectrally consistent units, separate classification of upland, wetland, and urban areas, and a hybrid supervised/unsupervised classification called "guided clustering." The final data had overall accuracies of 94% for Anderson Level I upland classes, 77% for Level II/III upland classes, and 84% for Level II/III wetland classes. Classification accuracies for deciduous and coniferous forest were 95% and 93%, respectively, and forest species' overall accuracies ranged from 70% to 84%. Limited availability of acceptable imagery necessitated use of an early May date in a majority of scene pairs, perhaps contributing to lower accuracy for upland deciduous forest species. The mixed deciduous/coniferous forest class had the lowest accuracy, most likely due to distinctly classifying a purely mixed class. Mixed forest signatures containing oak were often confused with pure oak. Guided clustering was seen as an efficient classification method, especially at the tree species level, although its success relied in part on image dates, accurate ground troth, and some analyst intervention. ?? 2002 Elsevier Science Inc. All rights reserved.

  19. Site classification for National Strong Motion Observation Network System (NSMONS) stations in China using an empirical H/V spectral ratio method

    NASA Astrophysics Data System (ADS)

    Ji, Kun; Ren, Yefei; Wen, Ruizhi

    2017-10-01

    Reliable site classification of the stations of the China National Strong Motion Observation Network System (NSMONS) has not yet been assigned because of lacking borehole data. This study used an empirical horizontal-to-vertical (H/V) spectral ratio (hereafter, HVSR) site classification method to overcome this problem. First, according to their borehole data, stations selected from KiK-net in Japan were individually assigned a site class (CL-I, CL-II, or CL-III), which is defined in the Chinese seismic code. Then, the mean HVSR curve for each site class was computed using strong motion recordings captured during the period 1996-2012. These curves were compared with those proposed by Zhao et al. (2006a) for four types of site classes (SC-I, SC-II, SC-III, and SC-IV) defined in the Japanese seismic code (JRA, 1980). It was found that an approximate range of the predominant period Tg could be identified by the predominant peak of the HVSR curve for the CL-I and SC-I sites, CL-II and SC-II sites, and CL-III and SC-III + SC-IV sites. Second, an empirical site classification method was proposed based on comprehensive consideration of peak period, amplitude, and shape of the HVSR curve. The selected stations from KiK-net were classified using the proposed method. The results showed that the success rates of the proposed method in identifying CL-I, CL-II, and CL-III sites were 63%, 64%, and 58% respectively. Finally, the HVSRs of 178 NSMONS stations were computed based on recordings from 2007 to 2015 and the sites classified using the proposed method. The mean HVSR curves were re-calculated for three site classes and compared with those from KiK-net data. It was found that both the peak period and the amplitude were similar for the mean HVSR curves derived from NSMONS classification results and KiK-net borehole data, implying the effectiveness of the proposed method in identifying different site classes. The classification results have good agreement with site classes based on borehole data of 81 stations in China, which indicates that our site classification results are acceptable and that the proposed method is practicable.

  20. A Comparative Study of YSO Classification Techniques using WISE Observations of the KR 120 Molecular Cloud

    NASA Astrophysics Data System (ADS)

    Kang, Sung-Ju; Kerton, C. R.

    2014-01-01

    KR 120 (Sh2-187) is a small Galactic HII region located at a distance of 1.4 kpc that shows evidence for triggered star formation in the surrounding molecular cloud. We present an analysis of the young stellar object (YSO) population of the molecular cloud as determined using a variety of classification techniques. YSO candidates are selected from the WISE all sky catalog and classified as Class I, Class II and Flat based on 1) spectral index, 2) color-color or color-magnitude plots, and 3) spectral energy distribution (SED) fits to radiative transfer models. We examine the discrepancies in YSO classification between the various techniques and explore how these discrepancies lead to uncertainty in such scientifically interesting quantities such as the ratio of Class I/Class II sources and the surface density of YSOs at various stages of evolution.

  1. Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

    PubMed

    2016-07-13

    The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  2. A 3-tier classification of cerebral arteriovenous malformations. Clinical article.

    PubMed

    Spetzler, Robert F; Ponce, Francisco A

    2011-03-01

    The authors propose a 3-tier classification for cerebral arteriovenous malformations (AVMs). The classification is based on the original 5-tier Spetzler-Martin grading system, and reflects the treatment paradigm for these lesions. The implications of this modification in the literature are explored. Class A combines Grades I and II AVMs, Class B are Grade III AVMs, and Class C combines Grades IV and V AVMs. Recommended management is surgery for Class A AVMs, multimodality treatment for Class B, and observation for Class C, with exceptions to the latter including recurrent hemorrhages and progressive neurological deficits. To evaluate whether combining grades is warranted from the perspective of surgical outcomes, the 3-tier system was applied to 1476 patients from 7 surgical series in which results were stratified according to Spetzler-Martin grades. Pairwise comparisons of individual Spetzler-Martin grades in the series analyzed showed the fewest significant differences (p < 0.05) in outcomes between Grades I and II AVMs and between Grades IV and V AVMs. In the pooled data analysis, significant differences in outcomes were found between all grades except IV and V (p = 0.38), and the lowest relative risks were found between Grades I and II (1.066) and between Grades IV and V (1.095). Using the pooled data, the predictive accuracies for surgical outcomes of the 5-tier and 3-tier systems were equivalent (receiver operating characteristic curve area 0.711 and 0.713, respectively). Combining Grades I and II AVMs and combining Grades IV and V AVMs is justified in part because the differences in surgical results between these respective pairs are small. The proposed 3-tier classification of AVMs offers simplification of the Spetzler-Martin system, provides a guide to treatment, and is predictive of outcome. The revised classification not only simplifies treatment recommendations; by placing patients into 3 as opposed to 5 groups, statistical power is markedly increased for series comparisons.

  3. 78 FR 1574 - Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... Infusion Pumps. 281 Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents... Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Legal Authority: 21 U.S.C... proposing to amend the classification of infusion pumps from class II (performance standards) to class II...

  4. Medical devices; immunology and microbiology devices; classification of John Cunningham Virus serological reagents. Final order.

    PubMed

    2014-01-23

    The Food and Drug Administration (FDA) is classifying John Cunningham Virus (JCV) serological reagents into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  5. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... Suction Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug Administration...- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II... ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative...

  6. Medical Devices; General Hospital and Personal Use Devices; Classification of the Ultraviolet Radiation Chamber Disinfection Device. Final order.

    PubMed

    2015-11-20

    The Food and Drug Administration (FDA or the Agency) is classifying the ultraviolet (UV) radiation chamber disinfection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the UV radiation chamber disinfection device classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  7. Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

    PubMed

    2017-07-27

    The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

  8. Occlusal Classification in Relation to Original Cleft Width in Patients With Unilateral Cleft Lip and Palate.

    PubMed

    Huang, Andrew H; Patel, Kamlesh B; Maschhoff, Clayton W; Huebener, Donald V; Skolnick, Gary B; Naidoo, Sybill D; Woo, Albert S

    2015-09-01

    To determine a correlation between the width of the cleft palate measured at the time of lip adhesion, definitive lip repair, and palatoplasty and the subsequent occlusal classification of patients born with unilateral cleft lip and palate. Retrospective, observational study. Referral, urban, children's hospital Participants : Dental models and records of 270 patients were analyzed. None. Angle occlusion classification. The mean age at which occlusal classification was determined was 11 ± 0.3 years. Of the children studies, 84 were diagnosed with Class I or II occlusion, 67 were diagnosed with Class III occlusion, and 119 were lost to follow up or transferred care. Mean cleft widths were significantly larger in subjects with Class III occlusion for all measures at time of lip adhesion and definitive lip repair (P < .02). At time of palatoplasty, cleft widths were significantly greater at the alveolus (P = .025) but not at the midportion of the hard palate (P = .35) or posterior hard palate (P = .10). Cleft widths from the lip through to the posterior hard palate are generally greater in children who are diagnosed with Class III occlusion later in life. Notably, the alveolar cleft width is significantly greater at each time point for patients who went on to develop Class III occlusion. There were no significant differences in cleft widths between patients diagnosed later with Class I and Class II occlusions.

  9. 21 CFR 7.41 - Health hazard evaluation and recall classification.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... exposed to the product being considered, with particular attention paid to the hazard to those individuals....e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product...

  10. 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... type of device is designed to achieve biological fixation to bone without the use of bone cement. This... bearing is rigidly secured to the metal tibial base plate. (b) Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint...

  11. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable...

  12. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...

  13. Orthopedic devices; classification for the resorbable calcium salt bone void filler device. Final rule.

    PubMed

    2003-06-02

    The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler device intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This action is being undertaken based on new information submitted in a classification proposal from Wright Medical Technology under the Federal Food, Drug, and Cosmetic Act as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.

  14. Correlation of the New York Heart Association Classification and the 6-Minute Walk Distance: A Systematic Review.

    PubMed

    Yap, Jonathan; Lim, Fang Yi; Gao, Fei; Teo, Ling Li; Lam, Carolyn Su Ping; Yeo, Khung Keong

    2015-10-01

    Functional status assessment is the cornerstone of heart failure management and trials. The New York Heart Association (NYHA) classification and 6-minute walk distance (6MWD) are commonly used tools; however, the correlation between them is not well understood. We hypothesised that the relationship between the NYHA classification and 6MWD might vary across studies. A systematic literature search was performed to identify all studies reporting both NYHA class and 6MWD. Two reviewers independently assessed study eligibility and extracted data. Thirty-seven studies involving 5678 patients were included. There was significant heterogeneity across studies in 6MWD within all NYHA classes: I (n = 16, Q = 934.2; P < 0.001), II (n = 25, Q = 1658.3; P < 0.001), III (n = 30, Q = 1020.1; P < 0.001), and IV (n = 6, Q = 335.5; P < 0.001). There was no significant difference in average 6MWD between NYHA I and II (420 m vs 393 m; P = 0.416). There was a significant difference in average 6MWD between NYHA II and III (393 m vs 321 m; P = 0.014) and III and IV (321 m vs 224 m; P = 0.027). This remained significant after adjusting for region of study, age, and sex. Although there is an inverse correlation between NYHA II-IV and 6MWD, there is significant heterogeneity across studies in 6MWD within each NYHA class and overlap in 6MWD between NYHA I and II. The NYHA classification performs well in more symptomatic patients (NYHA III/IV) but less so in asymptomatic/mildly symptomatic patients (NYHA I/II). Nonetheless, the NYHA classification is an easily applied first-line tool in everyday clinical practice, but its potential subjectivity should be considered when performing comparisons across studies. © 2015 Wiley Periodicals, Inc.

  15. Application of Aquatic Insects (Ephemeroptera, Plecoptera And Trichoptera) In Water Quality Assessment of Malaysian Headwater

    PubMed Central

    Ab Hamid, Suhaila; Md Rawi, Che Salmah

    2017-01-01

    The Ephemeroptera, Plecoptera and Trichoptera (EPT) community structure and the specific sensitivity of certain EPT genera were found to be influenced by water parameters in the rivers of Gunung Jerai Forest Reserve (GJFR) in the north of peninsular Malaysia. The scores of EPT taxa richness of >10 in all rivers indicated all rivers’ habitats were non-impacted, having good water quality coinciding with Class I and Class II of Malaysian water quality index (WQI) classification of potable water. The abundance of EPT was very high in Teroi River (9,661 individuals) but diversity was lower (22 genera) than Tupah River which was highly diverse (28 genera) but lower in abundance (4,263 individuals). The lowest abundance and moderate diversity was recorded from Batu Hampar River (25 genera). Baetis spp. and Thalerosphyrus spp., Neoperla spp. and Cheumatopsyche spp. were the most common genera found. Classification for all rivers using EPT taxa Richness Index and WQI gave different category of water quality, respectively. The WQI classified Tupah and Batu Hampar rivers into Class II and Teroi River (Class I) was two classes above the classification of the EPT taxa Richness Index. PMID:28890767

  16. Application of Aquatic Insects (Ephemeroptera, Plecoptera And Trichoptera) In Water Quality Assessment of Malaysian Headwater.

    PubMed

    Ab Hamid, Suhaila; Md Rawi, Che Salmah

    2017-07-01

    The Ephemeroptera, Plecoptera and Trichoptera (EPT) community structure and the specific sensitivity of certain EPT genera were found to be influenced by water parameters in the rivers of Gunung Jerai Forest Reserve (GJFR) in the north of peninsular Malaysia. The scores of EPT taxa richness of >10 in all rivers indicated all rivers' habitats were non-impacted, having good water quality coinciding with Class I and Class II of Malaysian water quality index (WQI) classification of potable water. The abundance of EPT was very high in Teroi River (9,661 individuals) but diversity was lower (22 genera) than Tupah River which was highly diverse (28 genera) but lower in abundance (4,263 individuals). The lowest abundance and moderate diversity was recorded from Batu Hampar River (25 genera). Baetis spp. and Thalerosphyrus spp., Neoperla spp. and Cheumatopsyche spp. were the most common genera found. Classification for all rivers using EPT taxa Richness Index and WQI gave different category of water quality, respectively. The WQI classified Tupah and Batu Hampar rivers into Class II and Teroi River (Class I) was two classes above the classification of the EPT taxa Richness Index.

  17. Assessing Angle's malocclusion among cleft lip and/or palate patients in Jammu.

    PubMed

    Gupta, Akshay; Gupta, Anur; Bhardwaj, Amit; Vikram, S; Gomathi, Ajeetha; Singh, Karanprakash

    2016-04-01

    The study was conducted to examine the patients with abnormalities of cleft lip and/or palate and its association with different types of malocclusion. This descriptive study was done among 168 patients with abnormalities of cleft lip and/or palate. Angle's classification of malocclusion was applied for assessment of occlusion as Class I, Class II, and Class III. The types of oral clefts classification such as cleft lip unilateral and cleft lip bilateral, cleft palate (CP), unilateral cleft lip with palate (UCLP) and bilateral cleft lip with palate (BCLP) was considered. Chi-square test was applied to analyze the data at P < 0.05. The study showed different categories of clefts patients as cleft lip (81), CP (31), and both cleft lip and palate (53). The occurrence of unilateral cleft lip (44) was maximum among the sample followed by UCLP (39), and bilateral cleft lip (31). Maximum subjects with Class II (10.7%) and Class III (4.9%) malocclusion were seen with unilateral cleft lip deformities. None of the patients with UCLP had Class III malocclusion. Cleft lip was the most commonly observed deformity and high frequency of Class II and III malocclusion was evident. Therefore, patients with such abnormalities should be screened timely.

  18. Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System. Final order.

    PubMed

    2018-01-02

    The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  19. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

    PubMed

    2017-10-18

    The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  20. Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System. Final order.

    PubMed

    2018-01-03

    The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  1. 21 CFR 864.8100 - Bothrops atrox reagent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen... the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen). (b) Classification. Class II (performance standards). [45...

  2. 21 CFR 864.8100 - Bothrops atrox reagent.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen... the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen). (b) Classification. Class II (performance standards). [45...

  3. Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms. Final order.

    PubMed

    2017-12-27

    The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  4. Medical devices; hematology and pathology devices; classification of early growth response 1 gene fluorescence in-situ hybridization test system for specimen characterization. Final order.

    PubMed

    2014-09-03

    The Food and Drug Administration (FDA) is classifying early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the early growth response 1 (EGR1) gene fluorescence in-site hybridization (FISH) test system for specimen characterization classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

  5. 77 FR 20656 - Postal Service Classification and Price Adjustments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ... noticing a recently-filed Postal Service notice announcing its intent to implement Picture Permit Imprint... implement Picture Permit Imprint Indicia as price categories for First-Class Mail and Standard Mail letters... Dominant Classification and Price Changes for Picture Permit Imprint Indicia, March 28, 2012 (Notice). II...

  6. Analysis of A Drug Target-based Classification System using Molecular Descriptors.

    PubMed

    Lu, Jing; Zhang, Pin; Bi, Yi; Luo, Xiaomin

    2016-01-01

    Drug-target interaction is an important topic in drug discovery and drug repositioning. KEGG database offers a drug annotation and classification using a target-based classification system. In this study, we gave an investigation on five target-based classes: (I) G protein-coupled receptors; (II) Nuclear receptors; (III) Ion channels; (IV) Enzymes; (V) Pathogens, using molecular descriptors to represent each drug compound. Two popular feature selection methods, maximum relevance minimum redundancy and incremental feature selection, were adopted to extract the important descriptors. Meanwhile, an optimal prediction model based on nearest neighbor algorithm was constructed, which got the best result in identifying drug target-based classes. Finally, some key descriptors were discussed to uncover their important roles in the identification of drug-target classes.

  7. Medical devices; hematology and pathology devices; classification of cord blood processing system and storage container. Final rule.

    PubMed

    2007-02-01

    The Food and Drug Administration (FDA) is classifying a cord blood processing system and storage container into class II (special controls). The special control that will apply to this device is the guidance document entitled "Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container." FDA is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

  8. 21 CFR 868.1800 - Rhinoanemometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1800 Rhinoanemometer. (a) Identification. A... differential pressure across, a patient's nasal passages. (b) Classification. Class II (performance standards). ...

  9. Relationship between foot posture and dental malocclusions in children aged 6 to 9 years

    PubMed Central

    Marchena-Rodríguez, Ana; Moreno-Morales, Noelia; Ramírez-Parga, Edith; Labajo-Manzanares, María Teresa; Luque-Suárez, Alejandro; Gijon-Nogueron, Gabriel

    2018-01-01

    Abstract The aim of this study was to determine the association, if any, between foot posture and dental malocclusions in the anteroposterior plane, in children. The study population consisted of 189 children (95 boys and 94 girls) aged 6 to 9 years. In every case, previous informed consent was requested and obtained from the parent/guardian and the study was approved by the Ethics Committee of the University of Málaga (CEUMA 26/2015H). This observational, descriptive, cross-sectional analysis is based on a study population (STROBE). Qualified personnel conducted a podiatric and dental examination of each child, recording the Clarke angle and the foot posture index (FPI) as an outcomes measure in the feet, and also dental malocclusions, according to Angle classification. A significant correlation was observed for the FPI scores (for right foot) as well as the Clarke angle (for right foot), in relation to dental malocclusions as determined by Angle classification (P < .001). Of all the supinated feet analyzed, 38.46% were Class II according to Angle classification, and none were Class III. Of the pronated feet, 48.57% were Class III, 42.85% were Class I, and 8.57% were Class II. The Clarke angle decreases with the progression from Class I to III, whereas the FPI increases with that from Class I to III. These findings suggest there is a relation between the Clarke angle and FPI, on the one hand, and dental malocclusion on the other. PMID:29742725

  10. Relationship between foot posture and dental malocclusions in children aged 6 to 9 years: A cross-sectional study.

    PubMed

    Marchena-Rodríguez, Ana; Moreno-Morales, Noelia; Ramírez-Parga, Edith; Labajo-Manzanares, María Teresa; Luque-Suárez, Alejandro; Gijon-Nogueron, Gabriel

    2018-05-01

    The aim of this study was to determine the association, if any, between foot posture and dental malocclusions in the anteroposterior plane, in children.The study population consisted of 189 children (95 boys and 94 girls) aged 6 to 9 years. In every case, previous informed consent was requested and obtained from the parent/guardian and the study was approved by the Ethics Committee of the University of Málaga (CEUMA 26/2015H).This observational, descriptive, cross-sectional analysis is based on a study population (STROBE). Qualified personnel conducted a podiatric and dental examination of each child, recording the Clarke angle and the foot posture index (FPI) as an outcomes measure in the feet, and also dental malocclusions, according to Angle classification.A significant correlation was observed for the FPI scores (for right foot) as well as the Clarke angle (for right foot), in relation to dental malocclusions as determined by Angle classification (P < .001). Of all the supinated feet analyzed, 38.46% were Class II according to Angle classification, and none were Class III. Of the pronated feet, 48.57% were Class III, 42.85% were Class I, and 8.57% were Class II.The Clarke angle decreases with the progression from Class I to III, whereas the FPI increases with that from Class I to III. These findings suggest there is a relation between the Clarke angle and FPI, on the one hand, and dental malocclusion on the other.

  11. Establishing the pharmaceutical quality of Chinese herbal medicine: a provisional BCS classification.

    PubMed

    Fong, Sophia Y K; Liu, Mary; Wei, Hai; Löbenberg, Raimar; Kanfer, Isadore; Lee, Vincent H L; Amidon, Gordon L; Zuo, Zhong

    2013-05-06

    The Biopharmaceutical Classification System (BCS), which is a scientific approach to categorize active drug ingredient based on its solubility and intestinal permeability into one of the four classes, has been used to set the pharmaceutical quality standards for drug products in western society. However, it has received little attention in the area of Chinese herbal medicine (CHM). This is likely, in part, due to the presence of multiple active components as well as lack of standardization of CHM. In this report, we apply BCS classification to CHMs provisionally as a basis for establishing improved in vitro quality standards. Based on a top-200 drugs selling list in China, a total of 31 CHM products comprising 50 official active marker compounds (AMCs) were provisionally classified according to BCS. Information on AMC content and doses of these CHM products were retrieved from the Chinese Pharmacopoeia. BCS parameters including solubility and permeability of the AMCs were predicted in silico (ACD/Laboratories). A BCS classification of CHMs according to biopharmaceutical properties of their AMCs is demonstrated to be feasible in the current study and can be used to provide a minimum set of quality standards. Our provisional results showed that 44% of the included AMCs were classified as Class III (high solubility, low permeability), followed by Class II (26%), Class I (18%), and Class IV (12%). A similar trend was observed when CHMs were classified in accordance with the BCS class of AMCs. Most (45%) of the included CHMs were classified as Class III, followed by Class II (16%), Class I (10%), and Class IV (6%); whereas 23% of the CHMs were of mixed class due to the presence of multiple individual AMCs with different BCS classifications. Moreover, about 60% of the AMCs were classified as high-solubility compounds (Class I and Class III), suggesting an important role for an in vitro dissolution test in setting quality control standards ensuring consistent biopharmaceutical quality for the commercially available CHM products. That is, provisionally, more than half of the AMCs of the top-selling CHMs included in this study would be candidates for a bioequivalence (BE) biowaiver, based on WHO recommendations and EMEA guidelines. Thus a dissolution requirement on these AMCs would represent a significant advance in the pharmaceutical quality of CHM today.

  12. 21 CFR 884.1700 - Hysteroscopic insufflator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... with a hysteroscope. (b) Classification. (1) Class II (performance standards). (2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only...

  13. 21 CFR 864.7425 - Carboxyhemoglobin assay.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry. (b) Classification. Class II (performance...

  14. 21 CFR 884.6130 - Assisted reproduction microtools.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. (b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin...

  15. 21 CFR 884.6130 - Assisted reproduction microtools.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. (b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin...

  16. 21 CFR 884.6130 - Assisted reproduction microtools.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. (b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin...

  17. 21 CFR 884.6130 - Assisted reproduction microtools.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. (b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin...

  18. 21 CFR 884.6130 - Assisted reproduction microtools.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. (b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin...

  19. 21 CFR 862.3350 - Diphenylhydantoin test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test... monitoring levels of diphenylhydantoin to ensure appropriate therapy. (b) Classification. Class II. ...

  20. Self-esteem in adolescents with Angle Class I, II and III malocclusion in a Peruvian sample.

    PubMed

    Florián-Vargas, Karla; Honores, Marcos J Carruitero; Bernabé, Eduardo; Flores-Mir, Carlos

    2016-01-01

    To compare self-esteem scores in 12 to 16-year-old adolescents with different Angle malocclusion types in a Peruvian sample. A cross-sectional study was conducted in a sample of 276 adolescents (159, 52 and 65 with Angle Class I, II and III malocclusions, respectively) from Trujillo, Peru. Participants were asked to complete the Rosenberg Self-Esteem Scale (RSES) and were also clinically examined, so as to have Angle malocclusion classification determined. Analysis of covariance (ANCOVA) was used to compare RSES scores among adolescents with Class I, II and III malocclusions, with participants' demographic factors being controlled. Mean RSES scores for adolescents with Class I, II and III malocclusions were 20.47 ± 3.96, 21.96 ± 3.27 and 21.26 ± 4.81, respectively. The ANCOVA test showed that adolescents with Class II malocclusion had a significantly higher RSES score than those with Class I malocclusion, but there were no differences between other malocclusion groups. Supplemental analysis suggested that only those with Class II, Division 2 malocclusion might have greater self-esteem when compared to adolescents with Class I malocclusion. This study shows that, in general, self-esteem did not vary according to adolescents' malocclusion in the sample studied. Surprisingly, only adolescents with Class II malocclusion, particularly Class II, Division 2, reported better self-esteem than those with Class I malocclusion. A more detailed analysis assessing the impact of anterior occlusal features should be conducted.

  1. Occlusal status in Asian male adults: prevalence and ethnic variation.

    PubMed

    Soh, Jen; Sandham, Andrew; Chan, Yiong Huak

    2005-09-01

    The purpose of this study was to determine the occlusal status in young Asian male adults of three ethnic groups. Study models of a sample of male army recruits (N = 339, age 17-22 years) with no history of orthodontic treatment were assessed. The ethnic proportions of the sample were Chinese 76.1% (n = 258), Malay 17.7% (n = 60), and Indian 6.2% (n = 21). British Standard Institute (BSI) and Angle's classification were used to determine incisor and molar relationships, respectively. Chi-square test or Fisher's Exact test was performed to compare the occlusal traits between ethnic groups. The distribution of incisor relationships of the total sample consisted of Class I = 48.1%, Class II/1 = 26.3%, Class II/2 = 3.2%, and Class III = 22.4%. Right Angle's molar relationships were 49.9%, 24.5%, and 24.2% whereas left Angle's molar relationships were 53.1%, 25.1%, and 21.2% for Class I, II, and III, respectively. Comparison between ethnic groups found that Indian subjects were more likely to have Class II/1 malocclusions and clinically missing permanent teeth (P < .05). The study found that the overall prevalence of malocclusion (BSI) was Class I, Class II/1, Class III, and Class II/2 in descending order of proportions. Angle's Class I molar was most prevalent followed by Class II and Class III relations. A significant difference in occlusal status between the ethnic groups was found regarding incisor relationship and missing permanent teeth (P < .05).

  2. Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss. Final order.

    PubMed

    2017-12-20

    The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  3. Comprehensive evaluation of functional and anatomical disorders of the patients with distal occlusion and accompanying obstructive sleep apnea syndrome

    NASA Astrophysics Data System (ADS)

    Nabiev, F. H.; Dobrodeev, A. S.; Libin, P. V.; Kotov, I. I.; Ovsyannikov, A. G.

    2015-11-01

    The paper defines the therapeutic and rehabilitation approach to the patients with Angle's classification Class II dento-facial anomalies, accompanied by obstructive sleep apnea (OSA). The proposed comprehensive approach to the diagnostics and treatment of patients with posterior occlusion, accompanied by OSA, allows for objective evaluation of intensity of a dento-facial anomaly and accompanying respiratory disorders in the nasal and oral pharynx, which allows for the pathophysiological mechanisms of OSA to be identified, and an optimal plan for surgical procedures to be developed. The proposed comprehensive approach to the diagnostics and treatment of patients with Angle's classification Class II dento-facial anomalies provides high functional and aesthetic results.

  4. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  5. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  6. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  7. An Evolving Digital Telecommunications Industry and Its Impact on the Operational Environment of the Nationwide Emergency Telecommunication System (NETS).

    DTIC Science & Technology

    1985-03-01

    005 4-, /nImII 1 liIm ulnli iiliiii I I UNCLASSIFIED SECURITY CLASSIFICATION OF TNIS PAGE ("on Data Bnter6t0 REPORT DOCUMENTATION PAGE READ...II different from ControllIng Office) 15. SECURITY CLASS (of thin report) Unclassified IS. OECLASSIFICATION/ DOWNGRADING SCMEDULE 1. DISTRIBUTION...EDITION OF I NOV 65 IS OBSOLETE UNCLASSIFIED N0102LF-0146601 1 UNCLASSIFIED SECURITY CLASSIFICATION OF THIS PAGE (When Dote wrteed) ,IA UNCLASSIFIED

  8. 21 CFR 864.7340 - Fibrinogen determination system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot). (b) Classification. Class II (performance standards...

  9. 21 CFR 864.7340 - Fibrinogen determination system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot). (b) Classification. Class II (performance standards...

  10. 21 CFR 864.7340 - Fibrinogen determination system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot). (b) Classification. Class II (performance standards...

  11. 21 CFR 864.7340 - Fibrinogen determination system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot). (b) Classification. Class II (performance standards...

  12. 21 CFR 864.7340 - Fibrinogen determination system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot). (b) Classification. Class II (performance standards...

  13. 21 CFR 876.4400 - Hemorrhoidal ligator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY DEVICES Surgical Devices § 876.4400 Hemorrhoidal ligator. (a... of a ligature or band placed around the hemorrhoid. (b) Classification. Class II (performance...

  14. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  15. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  16. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  17. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  18. 21 CFR 878.3300 - Surgical mesh.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3300 Surgical mesh. (a) Identification... acetabular and cement restrictor mesh used during orthopedic surgery. (b) Classification. Class II. ...

  19. 75 FR 33169 - Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    .... FDA-2008-N-0163] (formerly Docket No. 2001N-0067) RIN 0910-AG21 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam... the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II...

  20. Classification in Astronomy: Past and Present

    NASA Astrophysics Data System (ADS)

    Feigelson, Eric

    2012-03-01

    Astronomers have always classified celestial objects. The ancient Greeks distinguished between asteros, the fixed stars, and planetos, the roving stars. The latter were associated with the Gods and, starting with Plato in his dialog Timaeus, provided the first mathematical models of celestial phenomena. Giovanni Hodierna classified nebulous objects, seen with a Galilean refractor telescope in the mid-seventeenth century into three classes: "Luminosae," "Nebulosae," and "Occultae." A century later, Charles Messier compiled a larger list of nebulae, star clusters and galaxies, but did not attempt a classification. Classification of comets was a significant enterprise in the 19th century: Alexander (1850) considered two groups based on orbit sizes, Lardner (1853) proposed three groups of orbits, and Barnard (1891) divided them into two classes based on morphology. Aside from the segmentation of the bright stars into constellations, most stellar classifications were based on colors and spectral properties. During the 1860s, the pioneering spectroscopist Angelo Secchi classified stars into five classes: white, yellow, orange, carbon stars, and emission line stars. After many debates, the stellar spectral sequence was refined by the group at Harvard into the familiar OBAFGKM spectral types, later found to be a sequence on surface temperature (Cannon 1926). The spectral classification is still being extended with recent additions of O2 hot stars (Walborn et al. 2002) and L and T brown dwarfs (Kirkpatrick 2005). Townley (1913) reviews 30 years of variable star classification, emerging with six classes with five subclasses. The modern classification of variable stars has about 80 (sub)classes, and is still under debate (Samus 2009). Shortly after his confirmation that some nebulae are external galaxies, Edwin Hubble (1926) proposed his famous bifurcated classification of galaxy morphologies with three classes: ellipticals, spirals, and irregulars. These classes are still used today with many refinements by Gerard de Vaucouleurs and others. Supernovae, nearly all of which are found in external galaxies, have a complicated classification scheme:Type I with subtypes Ia, Ib, Ic, Ib/c pec and Type II with subtypes IIb, IIL, IIP, and IIn (Turatto 2003). The classification is based on elemental abundances in optical spectra and on optical light curve shapes. Tadhunter (2009) presents a three-dimensional classification of active galactic nuclei involving radio power, emission line width, and nuclear luminosity. These taxonomies have played enormously important roles in the development of astronomy, yet all were developed using heuristic methods. Many are based on qualitative and subjective assessments of spatial, temporal, or spectral properties. A qualitative, morphological approach to astronomical studies was explicitly promoted by Zwicky (1957). Other classifications are based on quantitative criteria, but these criteria were developed by subjective examination of training datasets. For example, starburst galaxies are discriminated from narrow-line Seyfert galaxies by a curved line in a diagramof the ratios of four emission lines (Veilleux and Osterbrock 1987). Class II young stellar objects have been defined by a rectangular region in a mid-infrared color-color diagram (Allen et al. 2004). Short and hard gamma-ray bursts are discriminated by a dip in the distribution of burst durations (Kouveliotou et al. 2000). In no case was a statistical or algorithmic procedure used to define the classes.

  1. 21 CFR 862.3150 - Barbiturate test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... in monitoring levels of barbiturate to ensure appropriate therapy. (b) Classification. Class II. ...

  2. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  3. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  4. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  5. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  6. 21 CFR 874.3820 - Endolymphatic shunt.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to... made of polytetrafluoroethylene or silicone elastomer. (b) Classification. Class II. ...

  7. 21 CFR 864.7470 - Glycosylated hemoglobin assay.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. (b) Classification. Class II (performance standards...

  8. 21 CFR 864.7470 - Glycosylated hemoglobin assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. (b) Classification. Class II (performance standards...

  9. 21 CFR 864.7470 - Glycosylated hemoglobin assay.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. (b) Classification. Class II (performance standards...

  10. 21 CFR 864.7470 - Glycosylated hemoglobin assay.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. (b) Classification. Class II (performance standards...

  11. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  12. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  13. 21 CFR 870.3800 - Annuloplasty ring.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency. (b) Classification. Class II (special...

  14. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  15. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  16. 21 CFR 866.5550 - Immunoglobulin (light chain specific) immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. (b) Classification. Class II (performance standards). ...

  17. 21 CFR 868.1760 - Volume plethysmograph.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes. (b) Classification. Class II (performance standards). ...

  18. 2D and 3D T2-weighted MR sequences for the assessment of neurovascular bundle changes after nerve-sparing radical retropubic prostatectomy with erectile function correlation.

    PubMed

    Panebianco, Valeria; Sciarra, Alessandro; Osimani, Marcello; Lisi, Danilo; Ciccariello, Mauro; Salciccia, Stefano; Gentile, Vincenzo; Di Silverio, Franco; Passariello, Roberto

    2009-01-01

    The aim of this study was to assess the capability of a 3D isotropic MRI T2-weighted sequence (3D T2 ISO) in the depiction of changes of neurovascular bundles (NVBs) after bilateral nerve-sparing radical retropubic prostatectomy (RRP). Furthermore, our aim was also to introduce a new MRI classification score of the NVB alteration patterns using the International Index Erectile Function Five-Item (IIEF-5) score as standard of reference. Fifty-three consecutive patients were postoperatively submitted to two MR examinations, including both 2D TSE T2-weighted (2D T2) and 3D T2 ISO sequences. Image findings were scored using a relative five-point classification and correlated with the postoperative IIEF-5 score. Radiologists attributed 13.2% of patients to class 0, 11.3% to class I, 34% to class II, 24.5% to class III, and 16.9% to class IV. With 3D T2 ISO images, the same radiologists determined 43.3% class 0, 32% class I, 11.4% class II, 7.5% class III, and 5.7% class IV. In all cases, the correlation and regression analysis between the 3D T2 ISO and IIEF-5 score resulted in higher coefficients values. The 3D sequence correlated most closely with patients' grading of erectile function.

  19. Post-boosting of classification boundary for imbalanced data using geometric mean.

    PubMed

    Du, Jie; Vong, Chi-Man; Pun, Chi-Man; Wong, Pak-Kin; Ip, Weng-Fai

    2017-12-01

    In this paper, a novel imbalance learning method for binary classes is proposed, named as Post-Boosting of classification boundary for Imbalanced data (PBI), which can significantly improve the performance of any trained neural networks (NN) classification boundary. The procedure of PBI simply consists of two steps: an (imbalanced) NN learning method is first applied to produce a classification boundary, which is then adjusted by PBI under the geometric mean (G-mean). For data imbalance, the geometric mean of the accuracies of both minority and majority classes is considered, that is statistically more suitable than the common metric accuracy. PBI also has the following advantages over traditional imbalance methods: (i) PBI can significantly improve the classification accuracy on minority class while improving or keeping that on majority class as well; (ii) PBI is suitable for large data even with high imbalance ratio (up to 0.001). For evaluation of (i), a new metric called Majority loss/Minority advance ratio (MMR) is proposed that evaluates the loss ratio of majority class to minority class. Experiments have been conducted for PBI and several imbalance learning methods over benchmark datasets of different sizes, different imbalance ratios, and different dimensionalities. By analyzing the experimental results, PBI is shown to outperform other imbalance learning methods on almost all datasets. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. 21 CFR 862.3640 - Morphine test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... monitoring levels of morphine and its analogs to ensure appropriate therapy. (b) Classification. Class II. ...

  1. 21 CFR 872.3645 - Subperiosteal implant material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw... intended to provide support for prostheses, such as dentures. (b) Classification. Class II. ...

  2. Comparison of temporomandibular joint and ramus morphology between class II and class III cases before and after bi-maxillary osteotomy.

    PubMed

    Iguchi, Ran; Yoshizawa, Kunio; Moroi, Akinori; Tsutsui, Takamitsu; Hotta, Asami; Hiraide, Ryota; Takayama, Akihiro; Tsunoda, Tatsuya; Saito, Yuki; Sato, Momoko; Baba, Nana; Ueki, Koichiro

    2017-12-01

    The purpose of this study was to compare changes in temporomandibular joint (TMJ) and ramus morphology between class II and III cases before and after sagittal split ramus osteotomy (SSRO) and Le Fort I osteotomy. The subjects were 39 patients (78 sides) who underwent bi-maxillary surgery. They consisted of 2 groups (18 class II cases and 21 class III cases), and were selected randomly from among patients who underwent surgery between 2012 and 2016. The TMJ disc tissue and joint effusion were assessed by magnetic resonance imaging (MRI) and the TMJ space, condylar height, ramus height, ramus inclination and condylar square were assessed by computed tomography (CT), pre- and post-operatively. The number of joints with anterior disc displacement in class II was significantly higher than that in class III (p < 0.0001). However, there were no significant differences between the two classes regarding ratio of joint symptoms and ratio of joint effusion pre- and post-operatively. Class II was significantly better than class III regarding reduction ratio of condylar height (p < 0.0001) and square (p = 0.0005). The study findings suggest that condylar morphology could change in both class II and III after bi-maxillary surgery. The findings of the numerical analysis also demonstrated that reduction of condylar volume occurred frequently in class II, although TMJ disc position classification did not change significantly, as previously reported. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  3. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid. Final order.

    PubMed

    2017-10-20

    The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid’s classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  4. Biowaiver or Bioequivalence: Ambiguity in Sildenafil Citrate BCS Classification.

    PubMed

    Miranda, Claudia; Pérez-Rodríguez, Zenia; Hernández-Armengol, Rosario; Quiñones-García, Yaidel; Betancourt-Purón, Tania; Cabrera-Pérez, Miguel Ángel

    2018-05-01

    The aim of the present study is to contribute to the scientific characterization of sildenafil citrate according to the Biopharmaceutics Classification System, following the World Health Organization (WHO) guidelines for biowaivers. The solubility and intestinal permeability data of sildenafil citrate were collected from literature; however, the experimental solubility studies are inconclusive and its "high permeability" suggests an API in the borderline of BCS Class I and Class II. The pH-solubility profile was determined using the saturation shake-flask method over the pH range of 1.2-6.8 at a temperature of 37 °C in aqueous media. The intestinal permeability was determined in rat by a closed-loop in situ perfusion method (the Doluisio technique). The solubility of sildenafil citrate is pH-dependent and at pH 6.8 the dose/solubility ratio obtained does not meet the WHO criteria for "high solubility." The high permeability values obtained by in situ intestinal perfusion in rat reinforce the published permeability data for sildenafil citrate. The experimental results obtained and the data available in the literature suggest that sildenafil citrate is clearly a Class II of BCS, according to the current biopharmaceutics classification system and WHO guidance.

  5. Application of Classification Methods for Forecasting Mid-Term Power Load Patterns

    NASA Astrophysics Data System (ADS)

    Piao, Minghao; Lee, Heon Gyu; Park, Jin Hyoung; Ryu, Keun Ho

    Currently an automated methodology based on data mining techniques is presented for the prediction of customer load patterns in long duration load profiles. The proposed approach in this paper consists of three stages: (i) data preprocessing: noise or outlier is removed and the continuous attribute-valued features are transformed to discrete values, (ii) cluster analysis: k-means clustering is used to create load pattern classes and the representative load profiles for each class and (iii) classification: we evaluated several supervised learning methods in order to select a suitable prediction method. According to the proposed methodology, power load measured from AMR (automatic meter reading) system, as well as customer indexes, were used as inputs for clustering. The output of clustering was the classification of representative load profiles (or classes). In order to evaluate the result of forecasting load patterns, the several classification methods were applied on a set of high voltage customers of the Korea power system and derived class labels from clustering and other features are used as input to produce classifiers. Lastly, the result of our experiments was presented.

  6. Biowaiver extension potential and IVIVC for BCS Class II drugs by formulation design: Case study for cyclosporine self-microemulsifying formulation.

    PubMed

    Yang, Su-Geun

    2010-11-01

    The objective of this work was to suggest the biowaiver potential of biopharmaceutical classification system (BCS) Class II drugs in self-microemulsifying drug delivery systems (SMEDDS) which are known to increase the solubility, dissolution and oral absorption of water-insoluble drugs. Cyclosporine was selected as a representative BCS Class II drug. New generic candidate of cyclosporine SMEDDS (test) was applied for the study with brand SMEDDS (reference I) and cyclosporine self-emulsifying drug delivery systems (SEDDS, reference II). Solubility and dissolution of cyclosporine from SMEDDS were critically enhanced, which were the similar behaviors with BCS class I drug. The test showed the identical dissolution rate and the equivalent bioavailability (0.34, 0.42 and 0.68 of p values for AUC₀(→)₂₄(h), C(max) and T(max), respectively) with the reference I. Based on the results, level A in vitro-in vivo correlation (IVIVC) was established from these two SMEDDS formulations. This study serves as a good example for speculating the biowaiver extension potential of BCS Class II drugs specifically in solubilizing formulation such as SMEDDS.

  7. 21 CFR 866.3930 - Vibrio cholerae serological reagents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    .... Cholera is an acute infectious disease characterized by severe diarrhea with extreme fluid and electrolyte... may lead to shock, renal failure, cardiovascular collapse, and death. (b) Classification. Class II...

  8. 21 CFR 868.6250 - Portable air compressor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. (b) Classification. Class II (performance...

  9. 21 CFR 868.6250 - Portable air compressor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. (b) Classification. Class II (performance...

  10. 21 CFR 866.3930 - Vibrio cholerae serological reagents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Cholera is an acute infectious disease characterized by severe diarrhea with extreme fluid and electrolyte... may lead to shock, renal failure, cardiovascular collapse, and death. (b) Classification. Class II...

  11. 21 CFR 862.1315 - Galactose-1-phosphate uridyl transferase test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells... hereditary disease galactosemia (disorder of galactose metabolism) in infants. (b) Classification. Class II. ...

  12. 21 CFR 864.7300 - Fibrin monomer paracoagulation test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot). (b) Classification. Class II...

  13. 21 CFR 864.7300 - Fibrin monomer paracoagulation test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot). (b) Classification. Class II...

  14. 21 CFR 864.7320 - Fibrinogen/fibrin degradation products assay.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels). (b) Classification. Class II (performance standards...

  15. 21 CFR 864.7300 - Fibrin monomer paracoagulation test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot). (b) Classification. Class II...

  16. 21 CFR 864.7320 - Fibrinogen/fibrin degradation products assay.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels). (b) Classification. Class II (performance standards...

  17. 21 CFR 864.7320 - Fibrinogen/fibrin degradation products assay.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels). (b) Classification. Class II (performance standards...

  18. 21 CFR 864.7300 - Fibrin monomer paracoagulation test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot). (b) Classification. Class II...

  19. 21 CFR 864.7320 - Fibrinogen/fibrin degradation products assay.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels). (b) Classification. Class II (performance standards...

  20. 21 CFR 864.7300 - Fibrin monomer paracoagulation test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot). (b) Classification. Class II...

  1. 21 CFR 884.4120 - Gynecologic electrocautery and accessories.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis... electrical generator, a probe, and electrical cables. (b) Classification. Class II (performance standards). ...

  2. 21 CFR 884.4120 - Gynecologic electrocautery and accessories.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis... electrical generator, a probe, and electrical cables. (b) Classification. Class II (performance standards). ...

  3. 21 CFR 884.4120 - Gynecologic electrocautery and accessories.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis... electrical generator, a probe, and electrical cables. (b) Classification. Class II (performance standards). ...

  4. 21 CFR 884.4120 - Gynecologic electrocautery and accessories.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis... electrical generator, a probe, and electrical cables. (b) Classification. Class II (performance standards). ...

  5. 21 CFR 884.4260 - Hygroscopic Laminaria cervical dilator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... conical and expansible material made from the root of a seaweed (Laminaria digitata or Laminaria japonica). The device is used to induce abortion. (b) Classification. Class II (performance standards). ...

  6. 21 CFR 882.5500 - Lesion temperature monitor.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe. (b) Classification. Class II (performance standards). ...

  7. 21 CFR 864.7290 - Factor deficiency test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene). (b) Classification. Class II (performance standards). [45 FR 60613...

  8. 21 CFR 884.1185 - Endometrial washer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... with negative pressure. This device is used to study endometrial cytology (cells). (b) Classification. Class II. The special controls for this device are: (1) FDA's: (i) “Use of International Organization...

  9. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  10. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  11. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo... span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt...

  12. 21 CFR 862.1440 - Lactate dehydrogenase test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. (b) Classification. Class II (special controls). The device is...

  13. 21 CFR 862.1440 - Lactate dehydrogenase test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. (b) Classification. Class II (special controls). The device is...

  14. 21 CFR 882.1310 - Cortical electrode.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. (b) Classification. Class II (performance...

  15. 21 CFR 882.1310 - Cortical electrode.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. (b) Classification. Class II (performance...

  16. 21 CFR 882.1310 - Cortical electrode.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. (b) Classification. Class II (performance...

  17. 21 CFR 882.1310 - Cortical electrode.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. (b) Classification. Class II (performance...

  18. 21 CFR 882.1310 - Cortical electrode.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. (b) Classification. Class II (performance...

  19. 21 CFR 882.5900 - Preformed craniosynostosis strip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together. (b) Classification. Class II...

  20. 21 CFR 868.1840 - Diagnostic spirometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. (b) Classification. Class II (performance standards). ...

  1. 21 CFR 868.1780 - Inspiratory airway pressure meter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... meter. (a) Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration. (b) Classification. Class II...

  2. 21 CFR 876.1735 - Electrogastrography system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... accessories. (b) Classification. Class II (Special Controls). The special controls are as follows: (1) The... describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To...

  3. 21 CFR 876.1735 - Electrogastrography system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... accessories. (b) Classification. Class II (Special Controls). The special controls are as follows: (1) The... describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To...

  4. 21 CFR 876.1735 - Electrogastrography system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... accessories. (b) Classification. Class II (Special Controls). The special controls are as follows: (1) The... describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To...

  5. 21 CFR 876.1735 - Electrogastrography system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... accessories. (b) Classification. Class II (Special Controls). The special controls are as follows: (1) The... describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To...

  6. 21 CFR 880.6910 - Wheeled stretcher.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The... frame may be fixed or collapsible for use in an ambulance. (b) Classification. Class II (special...

  7. 21 CFR 884.6110 - Assisted reproduction catheters.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body..., and component parts. (b) Classification. Class II (special controls) (mouse embryo assay information...

  8. 21 CFR 884.6110 - Assisted reproduction catheters.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body..., and component parts. (b) Classification. Class II (special controls) (mouse embryo assay information...

  9. 21 CFR 884.6110 - Assisted reproduction catheters.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body..., and component parts. (b) Classification. Class II (special controls) (mouse embryo assay information...

  10. 21 CFR 884.6110 - Assisted reproduction catheters.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body..., and component parts. (b) Classification. Class II (special controls) (mouse embryo assay information...

  11. 21 CFR 884.6110 - Assisted reproduction catheters.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body..., and component parts. (b) Classification. Class II (special controls) (mouse embryo assay information...

  12. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea. (b) Classification. Class II (performance standards). ...

  13. 21 CFR 868.5690 - Incentive spirometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation. (b) Classification. Class II...

  14. 21 CFR 868.5270 - Breathing system heater.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller. (b) Classification. Class II...

  15. The utility of rat jejunal permeability for biopharmaceutics classification system.

    PubMed

    Zakeri-Milani, Parvin; Valizadeh, Hadi; Tajerzadeh, Hosnieh; Islambulchilar, Ziba

    2009-12-01

    The biopharmaceutical classification system has been developed to provide a scientific approach for classifying drug compounds based on their dose/solubility ratio and human intestinal permeability. Therefore in this study a new classification is presented, which is based on a correlation between rat and human intestinal permeability values. In situ technique in rat jejunum was used to determine the effective intestinal permeability of tested drugs. Then three dimensionless parameters--dose number, absorption number, and dissolution number (D(o), A(n), and D(n))--were calculated for each drug. Four classes of drugs were defined, that is, class I, D(0) < 0.5, P(eff(rat)) > 5.09 x 10(-5) cm/s; class II, D(o) > 1, P(eff(rat)) > 5.09 x 10( -5) cm/s; class III, D(0) < 0.5, P(eff(rat)) < 4.2 x 10(-5) cm/s; and class IV, D(o) > 1, P(eff(rat)) < 4.2 x 10(-5) cm/s. A region of borderline drugs (0.5 < D(o) < 1, 4.2 x 10(-5) < P(eff(rat)) < 5.09 x 10(-5) cm/s) was also defined. According to obtained results and proposed classification for drugs, it is concluded that drugs could be categorized correctly based on dose number and their intestinal permeability values in rat model using single-pass intestinal perfusion technique. This classification enables us to remark defined characteristics for intestinal absorption of all four classes using suitable cutoff points for both dose number and rat effective intestinal permeability values.

  16. 21 CFR 876.5365 - Esophageal dilator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or... esophageal or gastrointestinal bougies and the esophageal dilator (metal olive). (b) Classification. Class II...

  17. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  18. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  19. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  20. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  1. 21 CFR 882.4100 - Ventricular catheter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance...

  2. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...

  3. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...

  4. 21 CFR 878.3720 - Tracheal prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The... include a device delivery system. (b) Classification. Class II. The special control for this device is FDA...

  5. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

  6. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

  7. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

  8. 21 CFR 884.3900 - Vaginal stent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... stent. (a) Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery. (b) Classification. Class II...

  9. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II. ...

  10. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II. ...

  11. 21 CFR 886.3320 - Eye sphere implant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact. (b) Classification. Class II. ...

  12. Correlation of the New York Heart Association classification and the cardiopulmonary exercise test: A systematic review.

    PubMed

    Lim, Fang Yi; Yap, Jonathan; Gao, Fei; Teo, Ling Li; Lam, Carolyn S P; Yeo, Khung Keong

    2018-07-15

    The New York Heart Association (NYHA) classification is frequently used in the management of heart failure but may be limited by patient and physician subjectivity. Cardiopulmonary exercise testing (CPET) provides a potentially more objective measurement of functional status. We aim to study the correlation between NYHA classification and peak oxygen consumption (pVO 2 ) on Cardiopulmonary Exercise Testing (CPET) within and across published studies. A systematic literature review on all studies reporting both NYHA class and CPET data was performed, and pVO 2 from CPET was correlated to reported NYHA class within and across eligible studies. 38 studies involving 2645 patients were eligible. Heterogenity was assessed by the Q statistic, which is a χ2 test and marker of systematic differences between studies. Within each NYHA class, significant heterogeneity in pVO 2 was seen across studies: NYHA I (n = 17, Q = 486.7, p < 0.0001), II (n = 24, Q = 381.0, p < 0.0001), III (n = 32, Q = 761.3, p < 0.0001) and IV (n = 5, Q = 12.8, p = 0.012). Significant differences in mean pVO 2 were observed between NYHA I and II (23.8 vs 17.6 mL/(kg·min), p < 0.0001) and II and III (17.6 vs 13.3 mL/(kg·min), p < 0.0001); but not between NYHA III and IV (13.3 vs 12.5 mL/(kg·min), p = 0.45). These differences remained significant after adjusting for age, gender, ejection fraction and region of study. There was a general inverse correlation between NYHA class and pVO 2. However, significant heterogeneity in pVO 2 exists across studies within each NYHA class. While the NYHA classification holds clinical value in heart failure management, direct comparison across studies may have its limitations. Copyright © 2018 Elsevier B.V. All rights reserved.

  13. Application of Wavelet Transform for PDZ Domain Classification

    PubMed Central

    Daqrouq, Khaled; Alhmouz, Rami; Balamesh, Ahmed; Memic, Adnan

    2015-01-01

    PDZ domains have been identified as part of an array of signaling proteins that are often unrelated, except for the well-conserved structural PDZ domain they contain. These domains have been linked to many disease processes including common Avian influenza, as well as very rare conditions such as Fraser and Usher syndromes. Historically, based on the interactions and the nature of bonds they form, PDZ domains have most often been classified into one of three classes (class I, class II and others - class III), that is directly dependent on their binding partner. In this study, we report on three unique feature extraction approaches based on the bigram and trigram occurrence and existence rearrangements within the domain's primary amino acid sequences in assisting PDZ domain classification. Wavelet packet transform (WPT) and Shannon entropy denoted by wavelet entropy (WE) feature extraction methods were proposed. Using 115 unique human and mouse PDZ domains, the existence rearrangement approach yielded a high recognition rate (78.34%), which outperformed our occurrence rearrangements based method. The recognition rate was (81.41%) with validation technique. The method reported for PDZ domain classification from primary sequences proved to be an encouraging approach for obtaining consistent classification results. We anticipate that by increasing the database size, we can further improve feature extraction and correct classification. PMID:25860375

  14. Comparison of BMI, AHI, and apolipoprotein E ε4 (APOE-ε4) alleles among sleep apnea patients with different skeletal classifications.

    PubMed

    Roedig, Jason J; Phillips, Barbara A; Morford, Lorri A; Van Sickels, Joseph E; Falcao-Alencar, Gabriel; Fardo, David W; Hartsfield, James K; Ding, Xiuhua; Kluemper, G Thomas

    2014-04-15

    This case-control study investigated whether variations within the APOE-ε gene were associated with having a convex facial profile (skeletal Class II) compared to exhibiting a straight or concave facial profile (Class I or Class III) among patients with obstructive sleep apnea (OSA). Associations between the apnea-hypopnea index (AHI) and body mass index (BMI) scores for these OSA patients were also examined in the context of facial profile. OSA patients with an AHI ≥ 15 were recruited from a sleep clinic and classified by facial and dental occlusal relationships based on a profile facial analysis, lateral photographs, and dental examination. Saliva was collected as a source of DNA. The APOE-ε1-4 allele-defining single nucleotide polymorphisms (SNPs) rs429358 and rs7412 were genotyped. A χ(2) analysis was used to assess Hardy-Weinberg equilibrium and for association analysis (significance at p < 0.05). ANOVA and Fisher exact test were also used. Seventy-six Caucasian OSA patients participated in the study-25 Class II cases and 51 non-Class II cases. There was no association of the APOE-ε4 allele with facial profile among these OSA patients. Class II OSA patients had significantly lower BMIs (30.7 ± 5.78) than Class I (37.3 ± 6.14) or Class III (37.8 ± 6.17) patients (p < 0.001), although there was no statistical difference in AHI for Class II patients compared with other groups. OSA patients with Class II convex profile were more likely to have a lower BMI than those in other skeletal groups. In fact 20% of them were not obese, suggesting that a Class II convex profile may influence or be associated with OSA development independent of BMI.

  15. Medical devices; immunology and microbiology devices; classification of nucleic acid-based devices for the detection of Mycobacterium tuberculosis complex and the genetic mutations associated with antibiotic resistance. Final order.

    PubMed

    2014-10-22

    The Food and Drug Administration (FDA) is classifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

  16. Cardiomyoplasty: first clinical case with new cardiomyostimulator.

    PubMed

    Chekanov, Valeri S; Sands, Duane E; Brown, Conville S; Brum, Fernando; Arzuaga, Pedro; Gava, Sebastian; Eugenio, Ferdinand P; Melamed, Vladimir; Spencer, Howard W

    2002-09-01

    Dynamic cardiomyoplasty was performed in a patient using a new cardio-myostimulator (LD-PACE II) designed to enable a novel stimulation regimen that utilizes a new range of stimulation options, including cessation during sleep. After treatment, left ventricular ejection fraction improved in 24 months from 15% to 25% and New York Heart Association classification improved from class IV to II.

  17. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye. (b) Classification. Class II. ...

  18. 21 CFR 886.1670 - Ophthalmic isotope uptake probe.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., by a probe which is placed in close proximity to the eye, the uptake of a radioisotope (phosphorus 32) by tumors to detect tumor masses on, around, or within the eye. (b) Classification. Class II. ...

  19. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  20. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  1. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  2. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  3. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  4. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  5. 21 CFR 870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. (b) Classification. Class II (special controls). The guidance...

  6. 21 CFR 870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. (b) Classification. Class II (special controls). The guidance...

  7. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  8. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  9. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  10. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  11. 21 CFR 872.3570 - OTC denture repair kit.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter. (b) Classification. Class II. The special...

  12. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  13. 21 CFR 886.3920 - Aqueous shunt.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  14. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  15. 21 CFR 886.3400 - Keratoprosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Classification. Class II. The special controls for this device are FDA's: (1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility...

  16. Pathognomonic features of Angle's Class II division 2 malocclusion: A comparative cephalometric and arch width study

    PubMed Central

    Prasad, Singamsetty E.R.V.; Indukuri, Ravikishore Reddy; Singh, Rupesh; Nooney, Anitha; Palagiri, Firoz Babu; Narayana, Veera

    2014-01-01

    Background: A thorough knowledge of the salient features of malocclusion helps the clinician in arriving at a proper diagnosis and treatment plan, and also to predict the prognosis, prior to the onset of treatment process. Among the four classes of Angle's classification of malocclusion, Class II division 2 occurs with the least frequency. There is still continuing debate in the literature whether the Class II division 2 patients ascribe the pathognomonic skeletal and dental features. Aim of the study: The aim of this study is to describe the unique features of Angle's Class II division 2 malocclusion to differentiate it from Angle's Class II division 1 malocclusion. Materials and Methods: A total of 582 pre-treatment records (study models and cephalograms), with the age of patients ranging from 15 to 22 years, were obtained from the hospital records of Vishnu Dental College, Bhimavaram and Geetam's Dental College, Visakhapatnam. Out of these, 11 pre-treatment records were excluded because of lack of clarity. In the rest of the sample, 283 were Class II division 1 and 288 were Class II division 2. The lateral cephalograms were analyzed by using digiceph and the arch width analysis was done based on the anatomical points described by Staley et al. and Sergl et al. Results: An intergroup evaluation was done by using unpaired Student's “t” test. The skeletal vertical parameters, dental parameters, and the maxillary arch width parameters revealed a statistically significant difference between the two groups of malocclusion. Conclusion: Angle's Class II division 2 malocclusion has a pronounced horizontal growth pattern with decreased lower anterior facial height, retroclined upper anteriors, and significantly increased maxillary arch width parameters. PMID:25558449

  17. Proposal of a Classification System for the Assessment and Treatment of Prominent Ear Deformity.

    PubMed

    Lee, Youngdae; Kim, Young Seok; Lee, Won Jai; Rha, Dong Kyun; Kim, Jiye

    2018-06-01

    Prominent ear is the most common external ear deformity. To comprehensively treat prominent ear deformity, adequate comprehension of its pathophysiology is crucial. In this article, we analyze cases of prominent ear and suggest a simple classification system and treatment algorithm according to pathophysiology. We retrospectively reviewed a total of 205 Northeast Asian patients' clinical data who underwent an operation for prominent ear deformity. Follow-up assessments were conducted 3, 6, and 12 months after surgery. Prominent ear deformities were classified by diagnostic checkpoints. Class I (simple prominent ear) includes prominent ear that developed with the absence of the antihelix without conchal hypertrophy. Class II (mixed-type prominent ear) is defined as having not only a flat antihelix, but also conchal excess. Class III (conchal-type prominent ear) has an enlarged conchal bowl with a well-developed antihelix. Among the three types of prominent ear, class I was most frequent (162 patients, 81.6%). Class II was observed in 28 patients (13.6%) and class III in 10 patients (4.8%). We used the scaphomastoid suture method for correction of antihelical effacement, the anterior approach conchal resection for correction of conchal hypertrophy, and Bauer's squid incision for lobule prominence. The complication rate was 9.2% including early hematoma, hypersensitivity, and suture extrusion. Unfavorable results occurred in 4% including partial recurrence, overcorrection, and undercorrection. To reduce unfavorable results and avoid recurrence, we propose the use of a classification and treatment algorithm in preoperative evaluation of prominent ear. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  18. 21 CFR 860.134 - Procedures for “new devices” under section 513(f) of the act and reclassification of certain...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... allows the petitioner to supplement a deficient petition. Within 30 days after any supplemental material... on it, the Commissioner may for good cause shown refer the petition to the appropriate classification... has classified the device into class I or class II in response to a petition for reclassification...

  19. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  20. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  1. 40 CFR 88.311-93 - Emissions standards for Inherently Low-Emission Vehicles.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... section depending on the vehicle's weight classification. (ii) The vehicle shall be certified as having... class shall have exhaust emissions which do not exceed the exhaust emission standards in grams per brake...

  2. 40 CFR 88.311-93 - Emissions standards for Inherently Low-Emission Vehicles.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... section depending on the vehicle's weight classification. (ii) The vehicle shall be certified as having... class shall have exhaust emissions which do not exceed the exhaust emission standards in grams per brake...

  3. 40 CFR 88.311-93 - Emissions standards for Inherently Low-Emission Vehicles.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... section depending on the vehicle's weight classification. (ii) The vehicle shall be certified as having... class shall have exhaust emissions which do not exceed the exhaust emission standards in grams per brake...

  4. 21 CFR 862.1155 - Human chorionic gonadotropin (HCG) test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class II. (b) Human... persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or...

  5. 21 CFR 862.1155 - Human chorionic gonadotropin (HCG) test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class II. (b) Human... persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or...

  6. 21 CFR 862.1155 - Human chorionic gonadotropin (HCG) test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class II. (b) Human... persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or...

  7. 21 CFR 862.1155 - Human chorionic gonadotropin (HCG) test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class II. (b) Human... persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or...

  8. 21 CFR 862.1155 - Human chorionic gonadotropin (HCG) test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... intended to measure HCG, a placental hormone, in plasma or urine. (2) Classification. Class II. (b) Human... persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or...

  9. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  10. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  11. 21 CFR 880.6992 - Medical washer-disinfector.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... instruments, anesthesia equipment, hollowware, and other medical devices. (b) Classification. Class II...-disinfectors that are intended to clean, high level disinfect, and dry surgical instruments, anesthesia..., low or intermediate level disinfect, and dry surgical instruments, anesthesia equipment, hollowware...

  12. Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis. Final order.

    PubMed

    2017-10-24

    The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  13. In silico prediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen.

    PubMed

    Tsume, Yasuhiro; Langguth, Peter; Garcia-Arieta, Alfredo; Amidon, Gordon L

    2012-10-01

    The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE results and in vitro dissolution results for BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH of 6.0. Further the experimental dissolution of ibuprofen tablets in a low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol l (-1) /pH) was dramatically reduced compared with the dissolution in SIF (the average buffer capacity 12.6 mmol l (-1) /pH). Thus these predictions for the oral absorption of BCS class II acids indicate that the absorption patterns depend largely on the intestinal pH and buffer strength and must be considered carefully for a bioequivalence test. Simulation software may be a very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. Copyright © 2012 John Wiley & Sons, Ltd.

  14. In Silico Prediction of Drug Dissolution and Absorption with variation in Intestinal pH for BCS Class II Weak Acid Drugs: Ibuprofen and Ketoprofen§

    PubMed Central

    Tsume, Yasuhiro; Langguth, Peter; Garcia-Arieta, Alfredo; Amidon, Gordon L.

    2012-01-01

    The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS Class III and BCS class II have been proposed, particularly, BCS class II weak acids. However, a discrepancy between the in vivo- BE results and in vitro- dissolution results for a BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient for in vitro bioequivalence studies of ibuprofen and ketoprofen as models of carboxylic acid drugs. The oral absorption of these BCS class II acids from the gastrointestinal tract was predicted by GastroPlus™. Ibuprofen did not satisfy the bioequivalence criteria at lower settings of intestinal pH=6.0. Further the experimental dissolution of ibuprofen tablets in the low concentration phosphate buffer at pH 6.0 (the average buffer capacity 2.2 mmol L-1/pH) was dramatically reduced compared to the dissolution in SIF (the average buffer capacity 12.6 mmol L -1/pH). Thus these predictions for oral absorption of BCS class II acids indicate that the absorption patterns largely depend on the intestinal pH and buffer strength and must be carefully considered for a bioequivalence test. Simulation software may be very useful tool to aid the selection of dissolution media that may be useful in setting an in vitro bioequivalence dissolution standard. PMID:22815122

  15. DNA methylation-based classification and grading system for meningioma: a multicentre, retrospective analysis.

    PubMed

    Sahm, Felix; Schrimpf, Daniel; Stichel, Damian; Jones, David T W; Hielscher, Thomas; Schefzyk, Sebastian; Okonechnikov, Konstantin; Koelsche, Christian; Reuss, David E; Capper, David; Sturm, Dominik; Wirsching, Hans-Georg; Berghoff, Anna Sophie; Baumgarten, Peter; Kratz, Annekathrin; Huang, Kristin; Wefers, Annika K; Hovestadt, Volker; Sill, Martin; Ellis, Hayley P; Kurian, Kathreena M; Okuducu, Ali Fuat; Jungk, Christine; Drueschler, Katharina; Schick, Matthias; Bewerunge-Hudler, Melanie; Mawrin, Christian; Seiz-Rosenhagen, Marcel; Ketter, Ralf; Simon, Matthias; Westphal, Manfred; Lamszus, Katrin; Becker, Albert; Koch, Arend; Schittenhelm, Jens; Rushing, Elisabeth J; Collins, V Peter; Brehmer, Stefanie; Chavez, Lukas; Platten, Michael; Hänggi, Daniel; Unterberg, Andreas; Paulus, Werner; Wick, Wolfgang; Pfister, Stefan M; Mittelbronn, Michel; Preusser, Matthias; Herold-Mende, Christel; Weller, Michael; von Deimling, Andreas

    2017-05-01

    The WHO classification of brain tumours describes 15 subtypes of meningioma. Nine of these subtypes are allotted to WHO grade I, and three each to grade II and grade III. Grading is based solely on histology, with an absence of molecular markers. Although the existing classification and grading approach is of prognostic value, it harbours shortcomings such as ill-defined parameters for subtypes and grading criteria prone to arbitrary judgment. In this study, we aimed for a comprehensive characterisation of the entire molecular genetic landscape of meningioma to identify biologically and clinically relevant subgroups. In this multicentre, retrospective analysis, we investigated genome-wide DNA methylation patterns of meningiomas from ten European academic neuro-oncology centres to identify distinct methylation classes of meningiomas. The methylation classes were further characterised by DNA copy number analysis, mutational profiling, and RNA sequencing. Methylation classes were analysed for progression-free survival outcomes by the Kaplan-Meier method. The DNA methylation-based and WHO classification schema were compared using the Brier prediction score, analysed in an independent cohort with WHO grading, progression-free survival, and disease-specific survival data available, collected at the Medical University Vienna (Vienna, Austria), assessing methylation patterns with an alternative methylation chip. We retrospectively collected 497 meningiomas along with 309 samples of other extra-axial skull tumours that might histologically mimic meningioma variants. Unsupervised clustering of DNA methylation data clearly segregated all meningiomas from other skull tumours. We generated genome-wide DNA methylation profiles from all 497 meningioma samples. DNA methylation profiling distinguished six distinct clinically relevant methylation classes associated with typical mutational, cytogenetic, and gene expression patterns. Compared with WHO grading, classification by individual and combined methylation classes more accurately identifies patients at high risk of disease progression in tumours with WHO grade I histology, and patients at lower risk of recurrence among WHO grade II tumours (p=0·0096) from the Brier prediction test). We validated this finding in our independent cohort of 140 patients with meningioma. DNA methylation-based meningioma classification captures clinically more homogenous groups and has a higher power for predicting tumour recurrence and prognosis than the WHO classification. The approach presented here is potentially very useful for stratifying meningioma patients to observation-only or adjuvant treatment groups. We consider methylation-based tumour classification highly relevant for the future diagnosis and treatment of meningioma. German Cancer Aid, Else Kröner-Fresenius Foundation, and DKFZ/Heidelberg Institute of Personalized Oncology/Precision Oncology Program. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Prevalence of vulvovaginitis and relation to physical findings in girls assessed for suspected child sexual abuse.

    PubMed

    Rahman, Gisel; Ocampo, Dolores; Rubinstein, Anahí; Risso, Paula

    2015-10-01

    The presence of sexually transmitted infections (STIs) in patients with suspected sexual abuse is uncommon in the field of pediatrics. To establish the prevalence of anogenital findings and their relation to the presence of STIs in girls referred for suspected child sexual abuse. Retrospective study conducted between January 1st, 2003 and December 31st, 2013. Physical findings and detection of STIs in girls with suspected child sexual abuse were analyzed. One thousand thirty-four patients were included. Their median age was 7.9 years old. Anogenital findings were classified as class I (normal):38.4%, class II (nonspecific):38.1%, class III (specific):19.9% and class IV (definitive):3.6%. STIs were observed in 42 patients (4.1%). A relation was established between STIs and the classification of physical findings: 10 (class II: 9; class III: 1) Neisseria gonorrhoeae, 17 (class I: 2; class II: 8; class III: 7) Chlamydia trachomatis, 15 (class I: 2; class II: 10; class III: 3) Trichomonas vaginalis. Statistically significant differences for Trichomonas vaginalis (p= 0.01) and Neisseria gonorrhoeae (p < 0.0001) were observed, with predominance of nonspecific clinical signs. Both nonspecific and specific findings were similarly observed for Chlamydia trachomatis (p= 0.03). Most cases of girls with suspected child sexual abuse had normal or nonspecific anogenital findings. The prevalence of STIs in these girls is low. Trichomonas vaginalis and Neisseria gonorrhoeae were related to nonspecific findings, while both nonspecific and specific findings were observed for Chlamydia trachomatis.

  17. The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.

    PubMed

    Tsume, Yasuhiro; Mudie, Deanna M; Langguth, Peter; Amidon, Greg E; Amidon, Gordon L

    2014-06-16

    The Biopharmaceutics Classification System (BCS) has found widespread utility in drug discovery, product development and drug product regulatory sciences. The classification scheme captures the two most significant factors influencing oral drug absorption; solubility and intestinal permeability and it has proven to be a very useful and a widely accepted starting point for drug product development and drug product regulation. The mechanistic base of the BCS approach has, no doubt, contributed to its wide spread acceptance and utility. Nevertheless, underneath the simplicity of BCS are many detailed complexities, both in vitro and in vivo which must be evaluated and investigated for any given drug and drug product. In this manuscript we propose a simple extension of the BCS classes to include sub-specification of acid (a), base (b) and neutral (c) for classes II and IV. Sub-classification for Classes I and III (high solubility drugs as currently defined) is generally not needed except perhaps in border line solubility cases. It is well known that the , pKa physical property of a drug (API) has a significant impact on the aqueous solubility dissolution of drug from the drug product both in vitro and in vivo for BCS Class II and IV acids and bases, and is the basis, we propose for a sub-classification extension of the original BCS classification. This BCS sub-classification is particularly important for in vivo predictive dissolution methodology development due to the complex and variable in vivo environment in the gastrointestinal tract, with its changing pH, buffer capacity, luminal volume, surfactant luminal conditions, permeability profile along the gastrointestinal tract and variable transit and fasted and fed states. We believe this sub-classification is a step toward developing a more science-based mechanistic in vivo predictive dissolution (IPD) methodology. Such a dissolution methodology can be used by development scientists to assess the likelihood of a formulation and dosage form functioning as desired in humans, can be optimized along with parallel human pharmacokinetic studies to set a dissolution methodology for Quality by Design (QbD) and in vitro-in vivo correlations (IVIVC) and ultimately can be used as a basis for a dissolution standard that will ensure continued in vivo product performance. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. The Biopharmaceutics Classification System: Subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC

    PubMed Central

    Tsume, Yasuhiro; Mudie, Deanna M.; Langguth, Peter; Amidon, Greg E.; Amidon, Gordon L.

    2014-01-01

    The Biopharmaceutics Classification System (BCS) has found widespread utility in drug discovery, product development and drug product regulatory sciences. The classification scheme captures the two most significant factors influencing oral drug absorption; solubility and intestinal permeability and it has proven to be a very useful and a widely accepted starting point for drug product development and drug product regulation. The mechanistic base of the BCS approach has, no doubt, contributed to its wide spread acceptance and utility. Nevertheless, underneath the simplicity of BCS are many detailed complexities, both in vitro and in vivo which must be evaluated and investigated for any given drug and drug product. In this manuscript we propose a simple extension of the BCS classes to include subspecification of acid (a), base (b) and neutral (c) for classes II and IV. Sub-classification for Classes I and III (high solubility drugs as currently defined) is generally not needed except perhaps in border line solubility cases. It is well known that the , pKa physical property of a drug (API) has a significant impact on the aqueous solubility dissolution of drug from the drug product both in vitro and in vivo for BCS Class II and IV acids and bases, and is the basis, we propose for a sub-classification extension of the original BCS classification. This BCS sub-classification is particularly important for in vivo predictive dissolution methodology development due to the complex and variable in vivo environment in the gastrointestinal tract, with its changing pH, buffer capacity, luminal volume, surfactant luminal conditions, permeability profile along the gastrointestinal tract and variable transit and fasted and fed states. We believe this sub-classification is a step toward developing a more science-based mechanistic in vivo predictive dissolution (IPD) methodology. Such a dissolution methodology can be used by development scientists to assess the likelihood of a formulation and dosage form functioning as desired in humans, can be optimized along with parallel human pharmacokinetic studies to set a dissolution methodology for Quality by Design (QbD) and in vitro–in vivo correlations (IVIVC) and ultimately can be used as a basis for a dissolution standard that will ensure continued in vivo product performance. PMID:24486482

  19. 21 CFR 882.4310 - Powered simple cranial drills, burrs, trephines, and their accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull. (b) Classification. Class II...

  20. 21 CFR 872.4840 - Rotary scaler.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

  1. 21 CFR 872.4840 - Rotary scaler.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

  2. 21 CFR 872.4840 - Rotary scaler.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

  3. 21 CFR 872.4840 - Rotary scaler.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

  4. 21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices..., pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II...

  5. 21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices..., pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II...

  6. 21 CFR 870.2780 - Hydraulic, pneumatic, or photoelectric plethysmographs.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Monitoring Devices..., pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques. (b) Classification. Class II...

  7. 21 CFR 872.4840 - Rotary scaler.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DENTAL DEVICES Surgical Devices § 872.4840 Rotary scaler. (a) Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy. (b) Classification. Class II. ...

  8. 21 CFR 882.5910 - Dura substitute.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain). (b) Classification. Class II (performance standards). ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  9. 21 CFR 868.1760 - Volume plethysmograph.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the patient's lung volume changes. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Volume plethysmograph. 868.1760 Section 868.1760...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1760 Volume plethysmograph. (a...

  10. 21 CFR 882.5030 - Methyl methacrylate for aneurysmorrhaphy.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip. (b) Classification. Class II (performance standards). ...

  11. 21 CFR 882.5030 - Methyl methacrylate for aneurysmorrhaphy.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip. (b) Classification. Class II (performance standards). ...

  12. 21 CFR 882.5030 - Methyl methacrylate for aneurysmorrhaphy.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip. (b) Classification. Class II (performance standards). ...

  13. 21 CFR 872.5500 - Extraoral orthodontic headgear.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to... patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth. (b) Classification. Class II. ...

  14. Prevalence of class-I, class-II and class-III obesity in Australian adults between 1995 and 2011-12.

    PubMed

    Keating, Catherine; Backholer, Kathryn; Gearon, Emma; Stevenson, Christopher; Swinburn, Boyd; Moodie, Marj; Carter, Rob; Peeters, Anna

    2015-01-01

    To compare the prevalence of class-I, II and III obesity in Australian adults between 1995, 2007-08 and 2011-12. Prevalence data for adults (aged 18+ years) were sourced from customised data from the nationally representative National Nutrition Survey (1995), the National Health Survey (2007-08), and the Australian Health Survey (2011-12) conducted by the Australian Bureau of Statistics. Obesity classifications were based on measured height and weight (class-I body mass index: 30.0-34.9 kg/m(2), class-II: 35.0-39.9 kg/m(2) and class-III: ≥ 40.0 kg/m(2)). Severe obesity was defined as class-II or class-III obesity. Between 1995 and 2011-12, the prevalence of obesity (all classes combined) increased from 19.1% to 27.2%. During this 17 year period, relative increases in class I, II and III obesity were 1.3, 1.7 and 2.2-fold respectively. In 2011-12, the prevalence of class I, II and III obesity was 19.4, 5.9 and 2.0 per cent respectively in men, and 16.1, 6.9 and 4.2 per cent respectively in women. One in every ten people was severely obese, increasing from one in twenty in 1995, and women were disproportionally represented in this population. Obesity prevalence increased with increasing levels of area-level socioeconomic disadvantage, particularly for the more severely obese classes. Severe obesity affected 6.2% and 13.4% in the least and most disadvantaged quintiles respectively. Over the last two decades, there have been substantial increases in the prevalence of obesity, particularly the more severe levels of obesity. This study highlights high risk groups who warrant targeted weight gain prevention interventions. Copyright © 2015 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  15. Predominant typologies of psychopathology in the United States: a latent class analysis.

    PubMed

    El-Gabalawy, Renée; Tsai, Jack; Harpaz-Rotem, Ilan; Hoff, Rani; Sareen, Jitender; Pietrzak, Robert H

    2013-11-01

    Latent class analysis (LCA) offers a parsimonious way of classifying common typologies of psychiatric comorbidity. We used LCA to identify the nature and correlates of predominant typologies of Axis I and II disorders in a large and comprehensive population-based sample of U.S. adults. We analyzed data from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions (2004-2005; n = 34,653), a population-based sample of U.S. adults. We derived latent classes based on all assessed Axis I and II disorders and examined the relationship between the identified Axis I classes and lifetime psychiatric disorders and suicide attempts, and physical and mental health-related quality of life. A four-class solution was optimal in characterizing predominant typologies of both Axis I and II disorders. For Axis I disorders, these included low psychopathology (n = 28,935, 84.0%), internalizing (n = 3693, 9.9%), externalizing (n = 1426, 4.5%), and high psychopathology (n = 599, 1.6%) classes. For Axis II disorders, these included no/low personality disorders (n = 31,265, 90.9%), obsessive/paranoid (n = 1635, 4.6%), borderline/dysregulated (n = 1319, 3.4%), and highly comorbid (n = 434, 1.1%) classes. Compared to the low psychopathology class, all other Axis I classes had significantly increased odds of mental disorders, elevated Axis II classes, suicide attempts and poorer quality of life, with the high psychopathology class having the overall highest rates of these correlates, with the exception of substance use disorders. Compared to the low psychopathology class, the internalizing and externalizing classes had increased rates of mood and anxiety disorders, and substance use disorders, respectively. Axis I and II psychopathology among U.S. adults may be best represented by four predominant typologies. Characterizing co-occurring patterns of psychopathology using person-based typologies represents a higher-order classification system that may be useful in clinical and research settings. Published by Elsevier Ltd.

  16. A neural network approach for enhancing information extraction from multispectral image data

    USGS Publications Warehouse

    Liu, J.; Shao, G.; Zhu, H.; Liu, S.

    2005-01-01

    A back-propagation artificial neural network (ANN) was applied to classify multispectral remote sensing imagery data. The classification procedure included four steps: (i) noisy training that adds minor random variations to the sampling data to make the data more representative and to reduce the training sample size; (ii) iterative or multi-tier classification that reclassifies the unclassified pixels by making a subset of training samples from the original training set, which means the neural model can focus on fewer classes; (iii) spectral channel selection based on neural network weights that can distinguish the relative importance of each channel in the classification process to simplify the ANN model; and (iv) voting rules that adjust the accuracy of classification and produce outputs of different confidence levels. The Purdue Forest, located west of Purdue University, West Lafayette, Indiana, was chosen as the test site. The 1992 Landsat thematic mapper imagery was used as the input data. High-quality airborne photographs of the same Lime period were used for the ground truth. A total of 11 land use and land cover classes were defined, including water, broadleaved forest, coniferous forest, young forest, urban and road, and six types of cropland-grassland. The experiment, indicated that the back-propagation neural network application was satisfactory in distinguishing different land cover types at US Geological Survey levels II-III. The single-tier classification reached an overall accuracy of 85%. and the multi-tier classification an overall accuracy of 95%. For the whole test, region, the final output of this study reached an overall accuracy of 87%. ?? 2005 CASI.

  17. 21 CFR 868.1690 - Nitrogen gas analyzer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... gas chromatography or mass spectrometry. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a...

  18. 21 CFR 868.1690 - Nitrogen gas analyzer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... gas chromatography or mass spectrometry. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nitrogen gas analyzer. 868.1690 Section 868.1690...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1690 Nitrogen gas analyzer. (a...

  19. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  20. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  1. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  2. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  3. 21 CFR 884.1425 - Perineometer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Perineometer. 884.1425 Section 884.1425 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... correct, through exercise, uninary incontinence or sexual dysfunction. (b) Classification. Class II...

  4. 21 CFR 868.1900 - Diagnostic pulmonary-function interpretation calculator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Diagnostic pulmonary-function interpretation calculator. 868.1900 Section 868.1900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... pulmonary-function values. (b) Classification. Class II (performance standards). ...

  5. 21 CFR 868.1900 - Diagnostic pulmonary-function interpretation calculator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Diagnostic pulmonary-function interpretation calculator. 868.1900 Section 868.1900 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... pulmonary-function values. (b) Classification. Class II (performance standards). ...

  6. 21 CFR 868.1620 - Halothane gas analyzer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... infrared or ultraviolet radiation. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Halothane gas analyzer. 868.1620 Section 868.1620 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  7. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  8. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  9. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  10. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  11. 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The... nonporous metal alloys, and used with or without bone cement. (b) Classification. Class II. [54 FR 48239...

  12. 21 CFR 870.4420 - Cardiopulmonary bypass cardiotomy return sucker.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass cardiotomy return sucker... Cardiopulmonary bypass cardiotomy return sucker. (a) Identification. A cardiopulmonary bypass cardiotomy return... from the chest or heart during cardiopulmonary bypass surgery. (b) Classification. Class II...

  13. 21 CFR 870.4420 - Cardiopulmonary bypass cardiotomy return sucker.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass cardiotomy return sucker... Cardiopulmonary bypass cardiotomy return sucker. (a) Identification. A cardiopulmonary bypass cardiotomy return... from the chest or heart during cardiopulmonary bypass surgery. (b) Classification. Class II...

  14. 21 CFR 882.4560 - Stereotaxic instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... part of the nervous system. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Stereotaxic instrument. 882.4560 Section 882.4560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  15. 21 CFR 882.4560 - Stereotaxic instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... part of the nervous system. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Stereotaxic instrument. 882.4560 Section 882.4560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  16. 21 CFR 882.4560 - Stereotaxic instrument.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... part of the nervous system. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Stereotaxic instrument. 882.4560 Section 882.4560 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  17. 21 CFR 864.8625 - Hematology quality control mixture.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC). (b) Classification. Class II (performance standards). [45 FR 60637, Sept. 12...

  18. 21 CFR 870.5900 - Thermal regulating system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... system. (a) Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature. (b) Classification. Class II (performance standards). ...

  19. Evaluation of the appropriateness and outcome of in-hospital telemetry monitoring.

    PubMed

    Fålun, Nina; Nordrehaug, Jan Erik; Hoff, Per Ivar; Langørgen, Jørund; Moons, Philip; Norekvål, Tone M

    2013-10-15

    The American Heart Association classifies monitored patients into 3 categories. The aims of this study were to (1) investigate how patients are assigned according to the American Heart Association classification, (2) determine the number and type of arrhythmic events experienced by these patients, and (3) describe subsequent changes in management. A prospective observational study design was used. All patients assigned to telemetry during a 3-month period were consecutively enrolled in our study. Data were collected 24/7. Only arrhythmias that might require a change in management were recorded. Monitor watchers at the central monitoring station completed a standard data sheet assessing 64 variables. These data, as well as medical records, were reviewed by the investigator. Overall, 1,194 patients were included. Eighteen percent of the patients were assigned to American Heart Association class I (monitoring indicated), 71% to class II (monitoring may be of benefit), and 11% to class III (monitoring not indicated). The overall arrhythmia event rate was 33%. Forty-three percent of class I patients, 28% of class II patients, and 47% of class III patients experienced arrhythmia events. Change in management occurred in 25% of class I patients, 14% of class II patients, and 29% of class III patients. Although the number of class III indications should have been reduced, nearly 1/2 of class III patients experienced arrhythmia events and 1/3 of them received management changes. This outcome challenges existing guidelines. In conclusion, most patients in this study were monitored appropriately, according to class I and II indications. Copyright © 2013 Elsevier Inc. All rights reserved.

  20. Neyman-Pearson classification algorithms and NP receiver operating characteristics

    PubMed Central

    Tong, Xin; Feng, Yang; Li, Jingyi Jessica

    2018-01-01

    In many binary classification applications, such as disease diagnosis and spam detection, practitioners commonly face the need to limit type I error (that is, the conditional probability of misclassifying a class 0 observation as class 1) so that it remains below a desired threshold. To address this need, the Neyman-Pearson (NP) classification paradigm is a natural choice; it minimizes type II error (that is, the conditional probability of misclassifying a class 1 observation as class 0) while enforcing an upper bound, α, on the type I error. Despite its century-long history in hypothesis testing, the NP paradigm has not been well recognized and implemented in classification schemes. Common practices that directly limit the empirical type I error to no more than α do not satisfy the type I error control objective because the resulting classifiers are likely to have type I errors much larger than α, and the NP paradigm has not been properly implemented in practice. We develop the first umbrella algorithm that implements the NP paradigm for all scoring-type classification methods, such as logistic regression, support vector machines, and random forests. Powered by this algorithm, we propose a novel graphical tool for NP classification methods: NP receiver operating characteristic (NP-ROC) bands motivated by the popular ROC curves. NP-ROC bands will help choose α in a data-adaptive way and compare different NP classifiers. We demonstrate the use and properties of the NP umbrella algorithm and NP-ROC bands, available in the R package nproc, through simulation and real data studies. PMID:29423442

  1. Neyman-Pearson classification algorithms and NP receiver operating characteristics.

    PubMed

    Tong, Xin; Feng, Yang; Li, Jingyi Jessica

    2018-02-01

    In many binary classification applications, such as disease diagnosis and spam detection, practitioners commonly face the need to limit type I error (that is, the conditional probability of misclassifying a class 0 observation as class 1) so that it remains below a desired threshold. To address this need, the Neyman-Pearson (NP) classification paradigm is a natural choice; it minimizes type II error (that is, the conditional probability of misclassifying a class 1 observation as class 0) while enforcing an upper bound, α, on the type I error. Despite its century-long history in hypothesis testing, the NP paradigm has not been well recognized and implemented in classification schemes. Common practices that directly limit the empirical type I error to no more than α do not satisfy the type I error control objective because the resulting classifiers are likely to have type I errors much larger than α, and the NP paradigm has not been properly implemented in practice. We develop the first umbrella algorithm that implements the NP paradigm for all scoring-type classification methods, such as logistic regression, support vector machines, and random forests. Powered by this algorithm, we propose a novel graphical tool for NP classification methods: NP receiver operating characteristic (NP-ROC) bands motivated by the popular ROC curves. NP-ROC bands will help choose α in a data-adaptive way and compare different NP classifiers. We demonstrate the use and properties of the NP umbrella algorithm and NP-ROC bands, available in the R package nproc, through simulation and real data studies.

  2. A survey of transposable element classification systems--a call for a fundamental update to meet the challenge of their diversity and complexity.

    PubMed

    Piégu, Benoît; Bire, Solenne; Arensburger, Peter; Bigot, Yves

    2015-05-01

    The increase of publicly available sequencing data has allowed for rapid progress in our understanding of genome composition. As new information becomes available we should constantly be updating and reanalyzing existing and newly acquired data. In this report we focus on transposable elements (TEs) which make up a significant portion of nearly all sequenced genomes. Our ability to accurately identify and classify these sequences is critical to understanding their impact on host genomes. At the same time, as we demonstrate in this report, problems with existing classification schemes have led to significant misunderstandings of the evolution of both TE sequences and their host genomes. In a pioneering publication Finnegan (1989) proposed classifying all TE sequences into two classes based on transposition mechanisms and structural features: the retrotransposons (class I) and the DNA transposons (class II). We have retraced how ideas regarding TE classification and annotation in both prokaryotic and eukaryotic scientific communities have changed over time. This has led us to observe that: (1) a number of TEs have convergent structural features and/or transposition mechanisms that have led to misleading conclusions regarding their classification, (2) the evolution of TEs is similar to that of viruses by having several unrelated origins, (3) there might be at least 8 classes and 12 orders of TEs including 10 novel orders. In an effort to address these classification issues we propose: (1) the outline of a universal TE classification, (2) a set of methods and classification rules that could be used by all scientific communities involved in the study of TEs, and (3) a 5-year schedule for the establishment of an International Committee for Taxonomy of Transposable Elements (ICTTE). Copyright © 2015 Elsevier Inc. All rights reserved.

  3. When do latent class models overstate accuracy for diagnostic and other classifiers in the absence of a gold standard?

    PubMed

    Spencer, Bruce D

    2012-06-01

    Latent class models are increasingly used to assess the accuracy of medical diagnostic tests and other classifications when no gold standard is available and the true state is unknown. When the latent class is treated as the true class, the latent class models provide measures of components of accuracy including specificity and sensitivity and their complements, type I and type II error rates. The error rates according to the latent class model differ from the true error rates, however, and empirical comparisons with a gold standard suggest the true error rates often are larger. We investigate conditions under which the true type I and type II error rates are larger than those provided by the latent class models. Results from Uebersax (1988, Psychological Bulletin 104, 405-416) are extended to accommodate random effects and covariates affecting the responses. The results are important for interpreting the results of latent class analyses. An error decomposition is presented that incorporates an error component from invalidity of the latent class model. © 2011, The International Biometric Society.

  4. 21 CFR 870.4340 - Cardiopulmonary bypass level sensing monitor and/or control.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass level sensing monitor and/or control. 870.4340 Section 870.4340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... value. (b) Classification. Class II (performance standards). ...

  5. 21 CFR 870.4340 - Cardiopulmonary bypass level sensing monitor and/or control.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass level sensing monitor and/or control. 870.4340 Section 870.4340 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... value. (b) Classification. Class II (performance standards). ...

  6. 21 CFR 876.4770 - Urethrotome.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Urethrotome. 876.4770 Section 876.4770 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES.... Some urethrotomes incorporate an optical channel for visual control. (b) Classification. Class II...

  7. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  8. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  9. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  10. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  11. 21 CFR 888.3027 - Polymethylmethacrylate (PMMA) bone cement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Polymethylmethacrylate (PMMA) bone cement. 888... Polymethylmethacrylate (PMMA) bone cement. (a) Identification. Polymethylmethacrylate (PMMA) bone cement is a device... metallic prosthetic implants to living bone. (b) Classification. Class II (special controls). The special...

  12. 21 CFR 870.4390 - Cardiopulmonary bypass pump tubing.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass pump tubing. 870.4390... bypass pump tubing. (a) Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is... through the cardiopulmonary bypass circuit. (b) Classification. Class II (performance standards). ...

  13. 21 CFR 870.4390 - Cardiopulmonary bypass pump tubing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass pump tubing. 870.4390... bypass pump tubing. (a) Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is... through the cardiopulmonary bypass circuit. (b) Classification. Class II (performance standards). ...

  14. 21 CFR 886.4440 - AC-powered magnet.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... metallic foreign bodies from eye tissue. (b) Classification. Class II. ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false AC-powered magnet. 886.4440 Section 886.4440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  15. 21 CFR 886.4440 - AC-powered magnet.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... metallic foreign bodies from eye tissue. (b) Classification. Class II. ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false AC-powered magnet. 886.4440 Section 886.4440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  16. 21 CFR 886.4440 - AC-powered magnet.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... metallic foreign bodies from eye tissue. (b) Classification. Class II. ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false AC-powered magnet. 886.4440 Section 886.4440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  17. 21 CFR 886.4440 - AC-powered magnet.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... metallic foreign bodies from eye tissue. (b) Classification. Class II. ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false AC-powered magnet. 886.4440 Section 886.4440 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  18. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  19. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  20. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  1. 21 CFR 880.6920 - Syringe needle introducer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Syringe needle introducer. 880.6920 Section 880.6920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... depth below the skin surface. (b) Classification. Class II (performance standards). ...

  2. 21 CFR 866.5750 - Radioallergosorbent (RAST) immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radioallergosorbent (RAST) immunological test system. 866.5750 Section 866.5750 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., allergies, and other pulmonary disorders. (b) Classification. Class II (performance standards). ...

  3. 21 CFR 880.6920 - Syringe needle introducer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Syringe needle introducer. 880.6920 Section 880.6920 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... depth below the skin surface. (b) Classification. Class II (performance standards). ...

  4. 21 CFR 864.9400 - Stabilized enzyme solution.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Stabilized enzyme solution. 864.9400 Section 864... and Blood Products § 864.9400 Stabilized enzyme solution. (a) Identification. A stabilized enzyme... enzyme solutions include papain, bromelin, ficin, and trypsin. (b) Classification. Class II (performance...

  5. 21 CFR 864.9400 - Stabilized enzyme solution.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Stabilized enzyme solution. 864.9400 Section 864... and Blood Products § 864.9400 Stabilized enzyme solution. (a) Identification. A stabilized enzyme... enzyme solutions include papain, bromelin, ficin, and trypsin. (b) Classification. Class II (performance...

  6. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  7. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  8. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  9. 21 CFR 866.5470 - Hemoglobin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... hemoglobin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, or other body fluids... Hemoglobin immunological test system. (a) Indentification. A hemoglobin immunological test system is a device... blood cells), and leukemia (cancer of the blood-forming organs). (b) Classification. Class II...

  10. 21 CFR 870.3450 - Vascular graft prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or... animal origin, including human umbilical cords. (b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular...

  11. 21 CFR 884.6160 - Assisted reproduction labware.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in..., dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media. (b)Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing...

  12. 21 CFR 884.6160 - Assisted reproduction labware.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in..., dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media. (b)Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing...

  13. 21 CFR 884.6160 - Assisted reproduction labware.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in..., dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media. (b)Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing...

  14. 21 CFR 884.6160 - Assisted reproduction labware.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in..., dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media. (b)Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing...

  15. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

  16. 21 CFR 884.5200 - Hemorrhoid prevention pressure wedge.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Hemorrhoid prevention pressure wedge. 884.5200... Devices § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. A hemorrhoid prevention... hemorrhoids associated with vaginal childbirth. (b) Classification. Class II (special controls). The special...

  17. 21 CFR 884.5200 - Hemorrhoid prevention pressure wedge.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Hemorrhoid prevention pressure wedge. 884.5200... Devices § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. A hemorrhoid prevention... hemorrhoids associated with vaginal childbirth. (b) Classification. Class II (special controls). The special...

  18. 21 CFR 884.5200 - Hemorrhoid prevention pressure wedge.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Hemorrhoid prevention pressure wedge. 884.5200... Devices § 884.5200 Hemorrhoid prevention pressure wedge. (a) Identification. A hemorrhoid prevention... hemorrhoids associated with vaginal childbirth. (b) Classification. Class II (special controls). The special...

  19. 21 CFR 870.5225 - External counter-pulsating device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., prescription device used to assist the heart by applying positive or negative pressure to one or more of the body's limbs in synchrony with the heart cycle. (b) Classification. (1) Class II (special controls... angina pectoris; acute myocardial infarction; cardiogenic shock; congestive heart failure; postoperative...

  20. Trainer Engineering Report (Final) for MILES. Volume 2. Revision

    DTIC Science & Technology

    1981-04-22

    formerly a separate document, Data Item AOOX. iii/iv 1A , SECURITY CLASSIFICATION OF THIS PAGE (Uhen Deaa Enterecd) ... __ . ....... REPORT DOCUMENTATION...NAVTRAEQUIPCEN, Orlando, FL 32813 3 14. MON’TORING AGENCY NAME & ADDRESS(II dilletent from CoftrollIn OGlue*) IS. SECURITY CLASS. (of thie twoot...OBSOLETE UNCLASSIFIED S/N 0102蓞-6601 I SECURITY CL.ASSIFICATION OF THIS iPAGE fUlses Data EaieteE i • CONTENTS .I * INTRODUCTION 1-1 1.1 1980 MILES 1-1

  1. Unsupervised hierarchical partitioning of hyperspectral images: application to marine algae identification

    NASA Astrophysics Data System (ADS)

    Chen, B.; Chehdi, K.; De Oliveria, E.; Cariou, C.; Charbonnier, B.

    2015-10-01

    In this paper a new unsupervised top-down hierarchical classification method to partition airborne hyperspectral images is proposed. The unsupervised approach is preferred because the difficulty of area access and the human and financial resources required to obtain ground truth data, constitute serious handicaps especially over large areas which can be covered by airborne or satellite images. The developed classification approach allows i) a successive partitioning of data into several levels or partitions in which the main classes are first identified, ii) an estimation of the number of classes automatically at each level without any end user help, iii) a nonsystematic subdivision of all classes of a partition Pj to form a partition Pj+1, iv) a stable partitioning result of the same data set from one run of the method to another. The proposed approach was validated on synthetic and real hyperspectral images related to the identification of several marine algae species. In addition to highly accurate and consistent results (correct classification rate over 99%), this approach is completely unsupervised. It estimates at each level, the optimal number of classes and the final partition without any end user intervention.

  2. An automatic method for skeletal patterns classification using craniomaxillary variables on a Colombian population.

    PubMed

    Niño-Sandoval, Tania Camila; Guevara Perez, Sonia V; González, Fabio A; Jaque, Robinson Andrés; Infante-Contreras, Clementina

    2016-04-01

    The mandibular bone is an important part of the forensic facial reconstruction and it has the possibility of getting lost in skeletonized remains; for this reason, it is necessary to facilitate the identification process simulating the mandibular position only through craniomaxillary measures, for this task, different modeling techniques have been performed, but they only contemplate a straight facial profile that belong to skeletal pattern Class I, but the 24.5% corresponding to the Colombian skeletal patterns Class II and III are not taking into account, besides, craniofacial measures do not follow a parametric trend or a normal distribution. The aim of this study was to employ an automatic non-parametric method as the Support Vector Machines to classify skeletal patterns through craniomaxillary variables, in order to simulate the natural mandibular position on a contemporary Colombian sample. Lateral cephalograms (229) of Colombian young adults of both sexes were collected. Landmark coordinates protocols were used to create craniomaxillary variables. A Support Vector Machine with a linear kernel classifier model was trained on a subset of the available data and evaluated over the remaining samples. The weights of the model were used to select the 10 best variables for classification accuracy. An accuracy of 74.51% was obtained, defined by Pr-A-N, N-Pr-A, A-N-Pr, A-Te-Pr, A-Pr-Rhi, Rhi-A-Pr, Pr-A-Te, Te-Pr-A, Zm-A-Pr and PNS-A-Pr angles. The Class Precision and the Class Recall showed a correct distinction of the Class II from the Class III and vice versa. Support Vector Machines created an important model of classification of skeletal patterns using craniomaxillary variables that are not commonly used in the literature and could be applicable to the 24.5% of the contemporary Colombian sample. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  3. Extensive traumatic anterior skull base fractures with cerebrospinal fluid leak: classification and repair techniques using combined vascularized tissue flaps.

    PubMed

    Archer, Jacob B; Sun, Hai; Bonney, Phillip A; Zhao, Yan Daniel; Hiebert, Jared C; Sanclement, Jose A; Little, Andrew S; Sughrue, Michael E; Theodore, Nicholas; James, Jeffrey; Safavi-Abbasi, Sam

    2016-03-01

    This article introduces a classification scheme for extensive traumatic anterior skull base fracture to help stratify surgical treatment options. The authors describe their multilayer repair technique for cerebrospinal fluid (CSF) leak resulting from extensive anterior skull base fracture using a combination of laterally pediculated temporalis fascial-pericranial, nasoseptal-pericranial, and anterior pericranial flaps. Retrospective chart review identified patients treated surgically between January 2004 and May 2014 for anterior skull base fractures with CSF fistulas. All patients were treated with bifrontal craniotomy and received pedicled tissue flaps. Cases were classified according to the extent of fracture: Class I (frontal bone/sinus involvement only); Class II (extent of involvement to ethmoid cribriform plate); and Class III (extent of involvement to sphenoid bone/sinus). Surgical repair techniques were tailored to the types of fractures. Patients were assessed for CSF leak at follow-up. The Fisher exact test was applied to investigate whether the repair techniques were associated with persistent postoperative CSF leak. Forty-three patients were identified in this series. Thirty-seven (86%) were male. The patients' mean age was 33 years (range 11-79 years). The mean overall length of follow-up was 14 months (range 5-45 months). Six fractures were classified as Class I, 8 as Class II, and 29 as Class III. The anterior pericranial flap alone was used in 33 patients (77%). Multiple flaps were used in 10 patients (3 salvage) (28%)--1 with Class II and 9 with Class III fractures. Five (17%) of the 30 patients with Class II or III fractures who received only a single anterior pericranial flap had persistent CSF leak (p < 0.31). No CSF leak was found in patients who received multiple flaps. Although postoperative CSF leak occurred only in high-grade fractures with single anterior flap repair, this finding was not significant. Extensive anterior skull base fractures often require aggressive treatment to provide the greatest long-term functional and cosmetic benefits. Several vascularized tissue flaps can be used, either alone or in combination. Vascularized flaps are an ideal substrate for cranial base repair. Dual and triple flap techniques that combine the use of various anterior, lateral, and nasoseptal flaps allow for a comprehensive arsenal in multilayered skull base repair and salvage therapy for extensive and severe fractures.

  4. A support vector machine for spectral classification of emission-line galaxies from the Sloan Digital Sky Survey

    NASA Astrophysics Data System (ADS)

    Shi, Fei; Liu, Yu-Yan; Sun, Guang-Lan; Li, Pei-Yu; Lei, Yu-Ming; Wang, Jian

    2015-10-01

    The emission-lines of galaxies originate from massive young stars or supermassive blackholes. As a result, spectral classification of emission-line galaxies into star-forming galaxies, active galactic nucleus (AGN) hosts, or compositions of both relates closely to formation and evolution of galaxy. To find efficient and automatic spectral classification method, especially in large surveys and huge data bases, a support vector machine (SVM) supervised learning algorithm is applied to a sample of emission-line galaxies from the Sloan Digital Sky Survey (SDSS) data release 9 (DR9) provided by the Max Planck Institute and the Johns Hopkins University (MPA/JHU). A two-step approach is adopted. (i) The SVM must be trained with a subset of objects that are known to be AGN hosts, composites or star-forming galaxies, treating the strong emission-line flux measurements as input feature vectors in an n-dimensional space, where n is the number of strong emission-line flux ratios. (ii) After training on a sample of emission-line galaxies, the remaining galaxies are automatically classified. In the classification process, we use a 10-fold cross-validation technique. We show that the classification diagrams based on the [N II]/Hα versus other emission-line ratio, such as [O III]/Hβ, [Ne III]/[O II], ([O III]λ4959+[O III]λ5007)/[O III]λ4363, [O II]/Hβ, [Ar III]/[O III], [S II]/Hα, and [O I]/Hα, plus colour, allows us to separate unambiguously AGN hosts, composites or star-forming galaxies. Among them, the diagram of [N II]/Hα versus [O III]/Hβ achieved an accuracy of 99 per cent to separate the three classes of objects. The other diagrams above give an accuracy of ˜91 per cent.

  5. Diabetic foot surgery: classifying patients to predict complications.

    PubMed

    Bevilacqua, Nicholas J; Rogers, Lee C; Armstrong, David G

    2008-01-01

    The purpose of this article is to describe a classification of diabetic foot surgery performed in the absence of critical limb ischaemia. The basis of this classification is centred on three fundamental variables that are present in the assessment of risk and indication: (1) presence or absence of neuropathy (the loss of protective sensation); (2) presence or absence of an open wound; (3) presence or absence of acute limb-threatening infection. The conceptual framework for this classification is to define distinct classes of surgery in an order of theoretically increasing risk for high-level amputation. These include: Class I: elective diabetic foot surgery (procedures performed to treat a painful deformity in a patient without the loss of protective sensation); Class II: prophylactic (procedure performed to reduce the risk of ulceration or reulceration in a person with the loss of protective sensation but without an open wound); Class III: curative (procedure performed to assist in healing an open wound); and Class IV: emergency (procedure performed to limit the progression of acute infection). The presence of critical ischaemia in any of these classes of surgery should prompt a vascular evaluation to consider (1) the urgency of the procedure being considered and (2) possible revascularization prior to or temporally concomitant with the procedure. It is our hope that this system begins a dialogue amongst physicians and surgeons which can ultimately facilitate communication, enhance perspective, and improve care.

  6. 21 CFR 868.1430 - Carbon monoxide gas analyzer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... techniques such as infrared absorption or gas chromatography. (b) Classification. Class II (performance... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Carbon monoxide gas analyzer. 868.1430 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1430 Carbon monoxide gas analyzer. (a...

  7. 21 CFR 868.1430 - Carbon monoxide gas analyzer.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... techniques such as infrared absorption or gas chromatography. (b) Classification. Class II (performance... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Carbon monoxide gas analyzer. 868.1430 Section 868...) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Diagnostic Devices § 868.1430 Carbon monoxide gas analyzer. (a...

  8. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  9. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  10. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  11. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  12. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  13. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  14. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  15. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  16. 21 CFR 872.4600 - Intraoral ligature and wire lock.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. An intraoral ligature and wire lock is a metal device intended to constrict fractured bone segments in the oral cavity. The bone segments are stabilized by wrapping the ligature (wire) around the fractured bone segments and locking the ends together. (b) Classification. Class II. ...

  17. 21 CFR 870.5300 - DC-defribrillator (including paddles).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  18. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  19. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  20. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  1. 21 CFR 866.5510 - Immunoglobulins A, G, M, D, and E immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunological... antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. (b) Classification. Class II...

  2. 21 CFR 866.5735 - Prothrombin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  3. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  4. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  5. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  6. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  7. 21 CFR 870.4280 - Cardiopulmonary prebypass filter.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary prebypass filter. 870.4280 Section... prebypass filter. (a) Identification. A cardiopulmonary prebypass filter is a device used during priming of... bypass. The device is not used to filter blood. (b) Classification. Class II (performance standards). ...

  8. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  9. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  10. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). (b) Classification. Class II... § 864.5600 Automated hematocrit instrument. (a) Identification. An automated hematocrit instrument is a...

  11. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). (b) Classification. Class II... § 864.5600 Automated hematocrit instrument. (a) Identification. An automated hematocrit instrument is a...

  12. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  13. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). (b) Classification. Class II... § 864.5600 Automated hematocrit instrument. (a) Identification. An automated hematocrit instrument is a...

  14. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  15. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). (b) Classification. Class II... § 864.5600 Automated hematocrit instrument. (a) Identification. An automated hematocrit instrument is a...

  16. 21 CFR 864.5600 - Automated hematocrit instrument.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). (b) Classification. Class II... § 864.5600 Automated hematocrit instrument. (a) Identification. An automated hematocrit instrument is a...

  17. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... addition of an aggregating reagent to a platelet-rich plasma. (b) Classification. Class II (performance... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automated platelet aggregation system. 864.5700... § 864.5700 Automated platelet aggregation system. (a) Identification. An automated platelet aggregation...

  18. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... addition of an aggregating reagent to a platelet-rich plasma. (b) Classification. Class II (performance... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Automated platelet aggregation system. 864.5700... § 864.5700 Automated platelet aggregation system. (a) Identification. An automated platelet aggregation...

  19. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... addition of an aggregating reagent to a platelet-rich plasma. (b) Classification. Class II (performance... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Automated platelet aggregation system. 864.5700... § 864.5700 Automated platelet aggregation system. (a) Identification. An automated platelet aggregation...

  20. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... addition of an aggregating reagent to a platelet-rich plasma. (b) Classification. Class II (performance... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Automated platelet aggregation system. 864.5700... § 864.5700 Automated platelet aggregation system. (a) Identification. An automated platelet aggregation...

  1. 21 CFR 864.5700 - Automated platelet aggregation system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... addition of an aggregating reagent to a platelet-rich plasma. (b) Classification. Class II (performance... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Automated platelet aggregation system. 864.5700... § 864.5700 Automated platelet aggregation system. (a) Identification. An automated platelet aggregation...

  2. 21 CFR 870.3720 - Pacemaker electrode function tester.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pacemaker electrode function tester. 870.3720... electrode function tester. (a) Identification. A pacemaker electrode function tester is a device which is... measuring the patient's pacing threshold and intracardiac R-wave potential. (b) Classification. Class II...

  3. 21 CFR 882.5330 - Preformed nonalterable cranioplasty plate.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Preformed nonalterable cranioplasty plate. 882.5330 Section 882.5330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... without changing the chemical behavior of the material. (b) Classification. Class II (performance...

  4. 21 CFR 882.5330 - Preformed nonalterable cranioplasty plate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Preformed nonalterable cranioplasty plate. 882.5330 Section 882.5330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... without changing the chemical behavior of the material. (b) Classification. Class II (performance...

  5. 21 CFR 882.5330 - Preformed nonalterable cranioplasty plate.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Preformed nonalterable cranioplasty plate. 882.5330 Section 882.5330 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... without changing the chemical behavior of the material. (b) Classification. Class II (performance...

  6. 21 CFR 864.5620 - Automated hemoglobin system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Automated hemoglobin system. 864.5620 Section 864....5620 Automated hemoglobin system. (a) Identification. An automated hemoglobin system is a fully... hemoglobin content of human blood. (b) Classification. Class II (performance standards). [45 FR 60601, Sept...

  7. 21 CFR 864.7415 - Abnormal hemoglobin assay.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864... hemoglobin assay. (a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents... hemoglobin types. (b) Classification. Class II (performance standards). [45 FR 60618, Sept. 12, 1980] ...

  8. 21 CFR 864.7415 - Abnormal hemoglobin assay.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Abnormal hemoglobin assay. 864.7415 Section 864... hemoglobin assay. (a) Identification. An abnormal hemoglobin assay is a device consisting of the reagents... hemoglobin types. (b) Classification. Class II (performance standards). [45 FR 60618, Sept. 12, 1980] ...

  9. 21 CFR 864.5620 - Automated hemoglobin system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Automated hemoglobin system. 864.5620 Section 864....5620 Automated hemoglobin system. (a) Identification. An automated hemoglobin system is a fully... hemoglobin content of human blood. (b) Classification. Class II (performance standards). [45 FR 60601, Sept...

  10. 21 CFR 870.5300 - DC-defribrillator (including paddles).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  11. 21 CFR 870.5300 - DC-defribrillator (including paddles).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  12. 21 CFR 870.5300 - DC-defibrillator (including paddles).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  13. 21 CFR 870.5300 - DC-defibrillator (including paddles).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy... either directly across the heart or on the surface of the body. (2) Classification. Class II (performance...

  14. 21 CFR 886.5928 - Soft (hydrophilic) contact lens care products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. (b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry...

  15. 21 CFR 886.5928 - Soft (hydrophilic) contact lens care products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. (b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry...

  16. 21 CFR 886.5928 - Soft (hydrophilic) contact lens care products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. (b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry...

  17. 21 CFR 886.5928 - Soft (hydrophilic) contact lens care products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. (b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry...

  18. 21 CFR 868.5935 - External negative pressure ventilator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ventilator. (a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. (b) Classification. Class II...

  19. Galaxy emission line classification using three-dimensional line ratio diagrams

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Vogt, Frédéric P. A.; Dopita, Michael A.; Kewley, Lisa J.

    2014-10-01

    Two-dimensional (2D) line ratio diagnostic diagrams have become a key tool in understanding the excitation mechanisms of galaxies. The curves used to separate the different regions—H II-like or excited by an active galactic nucleus (AGN)—have been refined over time but the core technique has not evolved significantly. However, the classification of galaxies based on their emission line ratios really is a multi-dimensional problem. Here we exploit recent software developments to explore the potential of three-dimensional (3D) line ratio diagnostic diagrams. We introduce the ZQE diagrams, which are a specific set of 3D diagrams that separate the oxygen abundance and themore » ionization parameter of H II region-like spectra and also enable us to probe the excitation mechanism of the gas. By examining these new 3D spaces interactively, we define the ZE diagnostics, a new set of 2D diagnostics that can provide the metallicity of objects excited by hot young stars and that cleanly separate H II region-like objects from the different classes of AGNs. We show that these ZE diagnostics are consistent with the key log [N II]/Hα versus log [O III]/Hβ diagnostic currently used by the community. They also have the advantage of attaching a probability that a given object belongs to one class or the other. Finally, we discuss briefly why ZQE diagrams can provide a new way to differentiate and study the different classes of AGNs in anticipation of a dedicated follow-up study.« less

  20. The optical re-brightening of nova M31N 2017-11a

    NASA Astrophysics Data System (ADS)

    Xu, Zhijian; Gao, Xing; Li, Yanxi; Zhao, Jingyuan; Zhang, Mi

    2017-12-01

    We report the initial discovery of the optical re-brightening of the Fe II class nova M31N 2017-11a (AT2017hvi = PTSS-17zap) which was first reported by PMO-Tsinghua Supernova Survey (PTSS, http://www.cneost.org/ptss/ ), (2017, TNS Discovery Report https://wis-tns.weizmann.ac.il/object/2017hvi) at r-Sloan magnitude 18.5 on 2017-11-04 16:41:02 UT. Spectroscopy by Williams & Darnley using the 2-m Liverpool telescope (ATel #10990) on 2017 Nov 20.11 UT, and by Fabrika et al., (ATel #10998) taken two days later at the Russian BTA telescope, showed Balmer emission lines together with numerous strong Fe II lines, confirming its classification as a classical Fe II class nova.

  1. 21 CFR 886.1300 - Afterimage flasher.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Afterimage flasher. 886.1300 Section 886.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... corresponding points on the retina have the same directional value). (b) Classification. Class II. [55 FR 48441...

  2. 21 CFR 886.1300 - Afterimage flasher.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Afterimage flasher. 886.1300 Section 886.1300 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL... corresponding points on the retina have the same directional value). (b) Classification. Class II. [55 FR 48441...

  3. 21 CFR 864.7140 - Activated whole blood clotting time tests.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Activated whole blood clotting time tests. 864....7140 Activated whole blood clotting time tests. (a) Identification. An activated whole blood clotting... pulmonary embolism by measuring the coagulation time of whole blood. (b) Classification. Class II...

  4. 21 CFR 866.6040 - Gene expression profiling test system for breast cancer prognosis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... cancer prognosis. 866.6040 Section 866.6040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... cancer prognosis. (a) Identification. A gene expression profiling test system for breast cancer prognosis... previously diagnosed breast cancer. (b) Classification. Class II (special controls). The special control is...

  5. 21 CFR 864.7140 - Activated whole blood clotting time tests.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Activated whole blood clotting time tests. 864....7140 Activated whole blood clotting time tests. (a) Identification. An activated whole blood clotting... pulmonary embolism by measuring the coagulation time of whole blood. (b) Classification. Class II...

  6. 21 CFR 864.7140 - Activated whole blood clotting time tests.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Activated whole blood clotting time tests. 864....7140 Activated whole blood clotting time tests. (a) Identification. An activated whole blood clotting... pulmonary embolism by measuring the coagulation time of whole blood. (b) Classification. Class II...

  7. 21 CFR 864.7140 - Activated whole blood clotting time tests.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Activated whole blood clotting time tests. 864....7140 Activated whole blood clotting time tests. (a) Identification. An activated whole blood clotting... pulmonary embolism by measuring the coagulation time of whole blood. (b) Classification. Class II...

  8. 21 CFR 864.7140 - Activated whole blood clotting time tests.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Activated whole blood clotting time tests. 864....7140 Activated whole blood clotting time tests. (a) Identification. An activated whole blood clotting... pulmonary embolism by measuring the coagulation time of whole blood. (b) Classification. Class II...

  9. 21 CFR 866.5270 - C-reactive protein immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. (b) Classification. Class II (performance standards). ....5270 Section 866.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  10. 21 CFR 866.5270 - C-reactive protein immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. (b) Classification. Class II (performance standards). ....5270 Section 866.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  11. 21 CFR 866.5270 - C-reactive protein immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. (b) Classification. Class II (performance standards). ....5270 Section 866.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  12. 21 CFR 866.5270 - C-reactive protein immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. (b) Classification. Class II (performance standards). ....5270 Section 866.5270 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  13. 21 CFR 866.6040 - Gene expression profiling test system for breast cancer prognosis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... cancer prognosis. 866.6040 Section 866.6040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... cancer prognosis. (a) Identification. A gene expression profiling test system for breast cancer prognosis... previously diagnosed breast cancer. (b) Classification. Class II (special controls). The special control is...

  14. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  15. 21 CFR 862.1295 - Folic acid test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow. (b) Classification. Class II. [52 FR 16122, May 1, 1987; 53 FR....1295 Folic acid test system. (a) Identification. A folic acid test system is a device intended to...

  16. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  17. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  18. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  19. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  20. 21 CFR 882.1935 - Near Infrared (NIR) Brain Hematoma Detector.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Near Infrared (NIR) Brain Hematoma Detector. 882... Infrared (NIR) Brain Hematoma Detector. (a) Identification. A Near Infrared (NIR) Brain Hematoma Detector... evaluate suspected brain hematomas. (b) Classification. Class II (special controls). The special controls...

  1. 21 CFR 882.1935 - Near Infrared (NIR) Brain Hematoma Detector.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Near Infrared (NIR) Brain Hematoma Detector. 882... Infrared (NIR) Brain Hematoma Detector. (a) Identification. A Near Infrared (NIR) Brain Hematoma Detector... evaluate suspected brain hematomas. (b) Classification. Class II (special controls). The special controls...

  2. 21 CFR 882.1610 - Alpha monitor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and... NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha... electroencephalogram which is referred to as the alpha wave. (b) Classification. Class II (performance standards). ...

  3. 21 CFR 882.1610 - Alpha monitor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and... NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha... electroencephalogram which is referred to as the alpha wave. (b) Classification. Class II (performance standards). ...

  4. 21 CFR 882.1610 - Alpha monitor.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Alpha monitor. 882.1610 Section 882.1610 Food and... NEUROLOGICAL DEVICES Neurological Diagnostic Devices § 882.1610 Alpha monitor. (a) Identification. An alpha... electroencephalogram which is referred to as the alpha wave. (b) Classification. Class II (performance standards). ...

  5. 21 CFR 864.9575 - Environmental chamber for storage of platelet concentrate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... to hold platelet-rich plasma within a preselected temperature range. (b) Classification. Class II... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Environmental chamber for storage of platelet... Establishments That Manufacture Blood and Blood Products § 864.9575 Environmental chamber for storage of platelet...

  6. 21 CFR 864.9575 - Environmental chamber for storage of platelet concentrate.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... to hold platelet-rich plasma within a preselected temperature range. (b) Classification. Class II... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Environmental chamber for storage of platelet... Establishments That Manufacture Blood and Blood Products § 864.9575 Environmental chamber for storage of platelet...

  7. 21 CFR 864.9575 - Environmental chamber for storage of platelet concentrate.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... to hold platelet-rich plasma within a preselected temperature range. (b) Classification. Class II... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Environmental chamber for storage of platelet... Establishments That Manufacture Blood and Blood Products § 864.9575 Environmental chamber for storage of platelet...

  8. 21 CFR 864.9575 - Environmental chamber for storage of platelet concentrate.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... to hold platelet-rich plasma within a preselected temperature range. (b) Classification. Class II... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Environmental chamber for storage of platelet... Establishments That Manufacture Blood and Blood Products § 864.9575 Environmental chamber for storage of platelet...

  9. 21 CFR 864.9575 - Environmental chamber for storage of platelet concentrate.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... to hold platelet-rich plasma within a preselected temperature range. (b) Classification. Class II... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Environmental chamber for storage of platelet... Establishments That Manufacture Blood and Blood Products § 864.9575 Environmental chamber for storage of platelet...

  10. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  11. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  12. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  13. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  14. 21 CFR 884.5160 - Powered breast pump.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... § 884.5160 Powered breast pump. (a) Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast. (b) Classification. Class II (performance standards). ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Powered breast pump. 884.5160 Section 884.5160...

  15. 21 CFR 870.4380 - Cardiopulmonary bypass pump speed control.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass pump speed control. 870... Cardiopulmonary bypass pump speed control. (a) Identification. A cardiopulmonary bypass pump speed control is a... control the speed of blood pumps used in cardiopulmonary bypass surgery. (b) Classification. Class II...

  16. 21 CFR 870.4380 - Cardiopulmonary bypass pump speed control.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass pump speed control. 870... Cardiopulmonary bypass pump speed control. (a) Identification. A cardiopulmonary bypass pump speed control is a... control the speed of blood pumps used in cardiopulmonary bypass surgery. (b) Classification. Class II...

  17. 21 CFR 866.6040 - Gene expression profiling test system for breast cancer prognosis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... cancer prognosis. 866.6040 Section 866.6040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... cancer prognosis. (a) Identification. A gene expression profiling test system for breast cancer prognosis... previously diagnosed breast cancer. (b) Classification. Class II (special controls). The special control is...

  18. 21 CFR 866.6040 - Gene expression profiling test system for breast cancer prognosis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... cancer prognosis. 866.6040 Section 866.6040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... cancer prognosis. (a) Identification. A gene expression profiling test system for breast cancer prognosis... previously diagnosed breast cancer. (b) Classification. Class II (special controls). The special control is...

  19. 21 CFR 866.6040 - Gene expression profiling test system for breast cancer prognosis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... cancer prognosis. 866.6040 Section 866.6040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... cancer prognosis. (a) Identification. A gene expression profiling test system for breast cancer prognosis... previously diagnosed breast cancer. (b) Classification. Class II (special controls). The special control is...

  20. 21 CFR 884.5460 - Scented or scented deodorized menstrual tampon.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... menstrual tampons treated with added antimicrobial agents or other drugs. (b) Classification. Class II... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Scented or scented deodorized menstrual tampon. 884.5460 Section 884.5460 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  1. Pichia pastoris is a Suitable Host for the Heterologous Expression of Predicted Class I and Class II Hydrophobins for Discovery, Study, and Application in Biotechnology

    PubMed Central

    Gandier, Julie-Anne; Master, Emma R.

    2018-01-01

    The heterologous expression of proteins is often a crucial first step in not only investigating their function, but also in their industrial application. The functional assembly and aggregation of hydrophobins offers intriguing biotechnological applications from surface modification to drug delivery, yet make developing systems for their heterologous expression challenging. In this article, we describe the development of Pichia pastoris KM71H strains capable of solubly producing the full set of predicted Cordyceps militaris hydrophobins CMil1 (Class IA), CMil2 (Class II), and CMil3 (IM) at mg/L yields with the use of 6His-tags not only for purification but for their detection. This result further demonstrates the feasibility of using P. pastoris as a host organism for the production of hydrophobins from all Ascomycota Class I subdivisions (a classification our previous work defined) as well as Class II. We highlight the specific challenges related to the production of hydrophobins, notably the challenge in detecting the protein that will be described, in particular during the screening of transformants. Together with the literature, our results continue to show that P. pastoris is a suitable host for the soluble heterologous expression of hydrophobins with a wide range of properties. PMID:29303996

  2. Pichia pastoris is a Suitable Host for the Heterologous Expression of Predicted Class I and Class II Hydrophobins for Discovery, Study, and Application in Biotechnology.

    PubMed

    Gandier, Julie-Anne; Master, Emma R

    2018-01-05

    The heterologous expression of proteins is often a crucial first step in not only investigating their function, but also in their industrial application. The functional assembly and aggregation of hydrophobins offers intriguing biotechnological applications from surface modification to drug delivery, yet make developing systems for their heterologous expression challenging. In this article, we describe the development of Pichia pastoris KM71H strains capable of solubly producing the full set of predicted Cordyceps militaris hydrophobins CMil1 (Class IA), CMil2 (Class II), and CMil3 (IM) at mg/L yields with the use of 6His-tags not only for purification but for their detection. This result further demonstrates the feasibility of using P. pastoris as a host organism for the production of hydrophobins from all Ascomycota Class I subdivisions (a classification our previous work defined) as well as Class II. We highlight the specific challenges related to the production of hydrophobins, notably the challenge in detecting the protein that will be described, in particular during the screening of transformants. Together with the literature, our results continue to show that P. pastoris is a suitable host for the soluble heterologous expression of hydrophobins with a wide range of properties.

  3. A probabilistic approach to emission-line galaxy classification

    NASA Astrophysics Data System (ADS)

    de Souza, R. S.; Dantas, M. L. L.; Costa-Duarte, M. V.; Feigelson, E. D.; Killedar, M.; Lablanche, P.-Y.; Vilalta, R.; Krone-Martins, A.; Beck, R.; Gieseke, F.

    2017-12-01

    We invoke a Gaussian mixture model (GMM) to jointly analyse two traditional emission-line classification schemes of galaxy ionization sources: the Baldwin-Phillips-Terlevich (BPT) and WH α versus [N II]/H α (WHAN) diagrams, using spectroscopic data from the Sloan Digital Sky Survey Data Release 7 and SEAGal/STARLIGHT data sets. We apply a GMM to empirically define classes of galaxies in a three-dimensional space spanned by the log [O III]/H β, log [N II]/H α and log EW(H α) optical parameters. The best-fitting GMM based on several statistical criteria suggests a solution around four Gaussian components (GCs), which are capable to explain up to 97 per cent of the data variance. Using elements of information theory, we compare each GC to their respective astronomical counterpart. GC1 and GC4 are associated with star-forming galaxies, suggesting the need to define a new starburst subgroup. GC2 is associated with BPT's active galactic nuclei (AGN) class and WHAN's weak AGN class. GC3 is associated with BPT's composite class and WHAN's strong AGN class. Conversely, there is no statistical evidence - based on four GCs - for the existence of a Seyfert/low-ionization nuclear emission-line region (LINER) dichotomy in our sample. Notwithstanding, the inclusion of an additional GC5 unravels it. The GC5 appears associated with the LINER and passive galaxies on the BPT and WHAN diagrams, respectively. This indicates that if the Seyfert/LINER dichotomy is there, it does not account significantly to the global data variance and may be overlooked by standard metrics of goodness of fit. Subtleties aside, we demonstrate the potential of our methodology to recover/unravel different objects inside the wilderness of astronomical data sets, without lacking the ability to convey physically interpretable results. The probabilistic classifications from the GMM analysis are publicly available within the COINtoolbox at https://cointoolbox.github.io/GMM_Catalogue/.

  4. Classifying northern forests using Thematic Mapper Simulator data

    NASA Technical Reports Server (NTRS)

    Nelson, R. F.; Latty, R. S.; Mott, G.

    1984-01-01

    Thematic Mapper Simulator data were collected over a 23,200 hectare forested area near Baxter State Park in north-central Maine. Photointerpreted ground reference information was used to drive a stratified random sampling procedure for waveband discriminant analyses and to generate training statistics and test pixel accuracies. Stepwise discriminant analyses indicated that the following bands best differentiated the thirteen level II - III cover types (in order of entry): near infrared (0.77 to 0.90 micron), blue (0.46 0.52 micron), first middle infrared (1.53 to 1.73 microns), second middle infrared (2.06 to 2.33 microsn), red (0.63 to 0.69 micron), thermal (10.32 to 12.33 microns). Classification accuracies peaked at 58 percent for thirteen level II-III land-cover classes and at 65 percent for ten level II classes.

  5. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  6. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  7. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  8. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  9. 21 CFR 888.3150 - Elbow joint metal/polymer constrained cemented prosthesis.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... use with bone cement (§ 888.3027). (b) Classification. Class II. The special controls for this device...) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone... Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F...

  10. 21 CFR 892.5050 - Medical charged-particle radiation therapy system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) intended for use in radiation therapy. This generic type of device may include signal analysis and display... accessories. (b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of...

  11. 21 CFR 870.4410 - Cardiopulmonary bypass in-line blood gas sensor.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary bypass in-line blood gas sensor... Cardiopulmonary bypass in-line blood gas sensor. (a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood. (b) Classification. Class II...

  12. 21 CFR 870.4410 - Cardiopulmonary bypass in-line blood gas sensor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary bypass in-line blood gas sensor... Cardiopulmonary bypass in-line blood gas sensor. (a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood. (b) Classification. Class II...

  13. 21 CFR 870.4410 - Cardiopulmonary bypass in-line blood gas sensor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary bypass in-line blood gas sensor... Cardiopulmonary bypass in-line blood gas sensor. (a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood. (b) Classification. Class II...

  14. 21 CFR 870.4410 - Cardiopulmonary bypass in-line blood gas sensor.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary bypass in-line blood gas sensor... Cardiopulmonary bypass in-line blood gas sensor. (a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood. (b) Classification. Class II...

  15. 21 CFR 870.4410 - Cardiopulmonary bypass in-line blood gas sensor.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary bypass in-line blood gas sensor... Cardiopulmonary bypass in-line blood gas sensor. (a) Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood. (b) Classification. Class II...

  16. 21 CFR 866.5785 - Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies to S. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection of S. cerevisiae antibodies may aid in the diagnosis of Crohn's disease. (b) Classification. Class II (special...

  17. 21 CFR 886.5928 - Soft (hydrophilic) contact lens care products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Soft (hydrophilic) contact lens care products. 886.5928 Section 886.5928 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... means of heat. (b) Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry...

  18. Digitized Speech Characteristics in Patients with Maxillectomy Defects.

    PubMed

    Elbashti, Mahmoud E; Sumita, Yuka I; Hattori, Mariko; Aswehlee, Amel M; Taniguchi, Hisashi

    2017-12-06

    Accurate evaluation of speech characteristics through formant frequency measurement is important for proper speech rehabilitation in patients after maxillectomy. This study aimed to evaluate the utility of digital acoustic analysis and vowel pentagon space for the prediction of speech ability after maxillectomy, by comparing the acoustic characteristics of vowel articulation in three classes of maxillectomy defects. Aramany's classifications I, II, and IV were used to group 27 male patients after maxillectomy. Digital acoustic analysis of five Japanese vowels-/a/, /e/, /i/, /o/, and /u/-was performed using a speech analysis system. First formant (F1) and second formant (F2) frequencies were calculated using an autocorrelation method. Data were plotted on an F1-F2 plane for each patient, and the F1 and F2 ranges were calculated. The vowel pentagon spaces were also determined. One-way ANOVA was applied to compare all results between the three groups. Class II maxillectomy patients had a significantly higher F2 range than did Class I and Class IV patients (p = 0.002). In contrast, there was no significant difference in the F1 range between the three classes. The vowel pentagon spaces were significantly larger in class II maxillectomy patients than in Class I and Class IV patients (p = 0.014). The results of this study indicate that the acoustic characteristics of maxillectomy patients are affected by the defect area. This finding may provide information for obturator design based on vowel articulation and defect class. © 2017 by the American College of Prosthodontists.

  19. DFT description of the magnetic properties and electron localization in dinuclear di-mu-oxo-bridged manganese complexes.

    PubMed

    Barone, Vincenzo; Bencini, Alessandro; Gatteschi, Dante; Totti, Federico

    2002-11-04

    Density functional theory (DFT) was applied to describe the magnetic and electron-transfer properties of dinuclear systems containing the [MnO2Mn]n+ core, with n=0,1,2,3,4. The calculation of the potential energy surfaces (PESs) of the mixed-valence species (n=1,3) allowed the classification of these systems according to the extent of valence localization as Class II compounds, in the Robin-Day classification scheme. The fundamental frequencies corresponding to the asymmetric breathing vibration were also computed.

  20. Leadership Ability and Achieving Styles among Student-Athletes at a NCAA-II University in the Northeast United States

    ERIC Educational Resources Information Center

    Nigro, Mary Theresa

    2012-01-01

    This study examined student-athletes' self-reported leadership ability and achieving styles. It analyzed leadership ability and achieving style preferences as they related to gender, class status, ethnicity, and sport classification: individual-sport vs. team-sport athletes. A paper and pencil survey consisting of a composite variable of six…

  1. Benchmark of Machine Learning Methods for Classification of a SENTINEL-2 Image

    NASA Astrophysics Data System (ADS)

    Pirotti, F.; Sunar, F.; Piragnolo, M.

    2016-06-01

    Thanks to mainly ESA and USGS, a large bulk of free images of the Earth is readily available nowadays. One of the main goals of remote sensing is to label images according to a set of semantic categories, i.e. image classification. This is a very challenging issue since land cover of a specific class may present a large spatial and spectral variability and objects may appear at different scales and orientations. In this study, we report the results of benchmarking 9 machine learning algorithms tested for accuracy and speed in training and classification of land-cover classes in a Sentinel-2 dataset. The following machine learning methods (MLM) have been tested: linear discriminant analysis, k-nearest neighbour, random forests, support vector machines, multi layered perceptron, multi layered perceptron ensemble, ctree, boosting, logarithmic regression. The validation is carried out using a control dataset which consists of an independent classification in 11 land-cover classes of an area about 60 km2, obtained by manual visual interpretation of high resolution images (20 cm ground sampling distance) by experts. In this study five out of the eleven classes are used since the others have too few samples (pixels) for testing and validating subsets. The classes used are the following: (i) urban (ii) sowable areas (iii) water (iv) tree plantations (v) grasslands. Validation is carried out using three different approaches: (i) using pixels from the training dataset (train), (ii) using pixels from the training dataset and applying cross-validation with the k-fold method (kfold) and (iii) using all pixels from the control dataset. Five accuracy indices are calculated for the comparison between the values predicted with each model and control values over three sets of data: the training dataset (train), the whole control dataset (full) and with k-fold cross-validation (kfold) with ten folds. Results from validation of predictions of the whole dataset (full) show the random forests method with the highest values; kappa index ranging from 0.55 to 0.42 respectively with the most and least number pixels for training. The two neural networks (multi layered perceptron and its ensemble) and the support vector machines - with default radial basis function kernel - methods follow closely with comparable performance.

  2. Multimethod latent class analysis

    PubMed Central

    Nussbeck, Fridtjof W.; Eid, Michael

    2015-01-01

    Correct and, hence, valid classifications of individuals are of high importance in the social sciences as these classifications are the basis for diagnoses and/or the assignment to a treatment. The via regia to inspect the validity of psychological ratings is the multitrait-multimethod (MTMM) approach. First, a latent variable model for the analysis of rater agreement (latent rater agreement model) will be presented that allows for the analysis of convergent validity between different measurement approaches (e.g., raters). Models of rater agreement are transferred to the level of latent variables. Second, the latent rater agreement model will be extended to a more informative MTMM latent class model. This model allows for estimating (i) the convergence of ratings, (ii) method biases in terms of differential latent distributions of raters and differential associations of categorizations within raters (specific rater bias), and (iii) the distinguishability of categories indicating if categories are satisfyingly distinct from each other. Finally, an empirical application is presented to exemplify the interpretation of the MTMM latent class model. PMID:26441714

  3. A New Classification System for IgG4 Autoantibodies

    PubMed Central

    Koneczny, Inga

    2018-01-01

    IgG4 autoimmune diseases are characterized by the presence of antigen-specific autoantibodies of the IgG4 subclass and contain well-characterized diseases such as muscle-specific kinase myasthenia gravis, pemphigus, and thrombotic thrombocytopenic purpura. In recent years, several new diseases were identified, and by now 14 antigens targeted by IgG4 autoantibodies have been described. The IgG4 subclass is considered immunologically inert and functionally monovalent due to structural differences compared to other IgG subclasses. IgG4 usually arises after chronic exposure to antigen and competes with other antibody species, thus “blocking” their pathogenic effector mechanisms. Accordingly, in the context of IgG4 autoimmunity, the pathogenicity of IgG4 is associated with blocking of enzymatic activity or protein–protein interactions of the target antigen. Pathogenicity of IgG4 autoantibodies has not yet been systematically analyzed in IgG4 autoimmune diseases. Here, we establish a modified classification system based on Witebsky’s postulates to determine IgG4 pathogenicity in IgG4 autoimmune diseases, review characteristics and pathogenic mechanisms of IgG4 in these disorders, and also investigate the contribution of other antibody entities to pathophysiology by additional mechanisms. As a result, three classes of IgG4 autoimmune diseases emerge: class I where IgG4 pathogenicity is validated by the use of subclass-specific autoantibodies in animal models and/or in vitro models of pathogenicity; class II where IgG4 pathogenicity is highly suspected but lack validation by the use of subclass specific antibodies in in vitro models of pathogenicity or animal models; and class III with insufficient data or a pathogenic mechanism associated with multivalent antigen binding. Five out of the 14 IgG4 antigens were validated as class I, five as class II, and four as class III. Antibodies of other IgG subclasses or immunoglobulin classes were present in several diseases and could contribute additional pathogenic mechanisms. PMID:29483905

  4. Medical devices; hematology and pathology devices; classification of the Factor V Leiden DNA mutation detection systems devices. Final rule.

    PubMed

    2004-03-16

    The Food and Drug Administration (FDA) is classifying the Factor V Leiden deoxyribonucleic acid (DNA) mutation detections systems device into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

  5. Proposal for a bariatric mortality risk classification system for patients undergoing bariatric surgery.

    PubMed

    Nguyen, Ninh T; Nguyen, Brian; Smith, Brian; Reavis, Kevin M; Elliott, Christian; Hohmann, Samuel

    2013-01-01

    An obesity surgery mortality risk score derived from a single clinical series can be used to stratify the mortality risk of patients undergoing gastric bypass. However, such a scoring system does not take into account 2 important factors in contemporary bariatric surgery--increased use of the laparoscopic approach and laparoscopic adjustable gastric banding. The present study analyzed the preoperative factors that might predict in-hospital mortality after bariatric surgery using data from academic medical centers and proposes a classification system for predicting mortality. Using the "International Classification of Diseases, 9th revision," diagnosis and procedural codes, the data for all patients who underwent bariatric surgery for the treatment of morbid obesity from 2002 to 2009 were obtained from the University HealthSystem Consortium database. The limitations of this database included the lack of the body mass index and the underestimation of some co-morbidities, such as sleep apnea. Multiple regression analyses were performed to determine the factors predictive of greater in-hospital mortality. The factors examined included race, gender, age, co-morbidities, surgical technique (laparoscopic versus open), bariatric operation (gastric bypass versus nongastric bypass), and payer type. A scoring system was devised by assigning 1 point for each major factor (those with an adjusted odds ratio [AOR] of ≥2.0) and .5 point for each minor factor (those with an AOR <2.0). Using contemporary data from 2007 to 2009, the in-hospital mortality was analyzed according to the classification: class I, 0-0.5 point; class II, 1.0-1.5 points; class III, 2.0-3.0 points; and class IV, ≥3.5 points. During the 8-year period, 105,287 patients underwent bariatric surgery. The operations included laparoscopic gastric bypass (45%), open gastric bypass (41%), and laparoscopic gastric banding or gastroplasty (14%). The overall in-hospital mortality rate was .17%. The number of deaths per 1000 bariatric operations decreased from 4.0 in 2002 to .6 in 2009. Using regression analyses, the factors predictive of greater in-hospital mortality were male gender (AOR 3.2), gastric bypass procedure (AOR 5.8), open surgical technique (AOR 4.8), Medicare payer (AOR 3.0), diabetes (AOR 1.6), and age >60 years (AOR 1.9). The mortality rate was .10% for class I patients, .15% for class II, .33% for class III, and .70% for class IV (P < .05 among all classes). Within the context of academic centers, the mortality after bariatric surgery has decreased substantially since 2002, with an increase in the use of the laparoscopic technique and laparoscopic gastric banding. A bariatric mortality risk classification system was developed to stratify mortality, given the limits of this database, which does not include the body mass index and underestimates the incidence of sleep apnea. It might be useful to aid surgeons in surgical decision-making, to inform patients of their risks, and for quality improvement reporting purposes. Copyright © 2013 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  6. Classification of ulnar triangular fibrocartilage complex tears. A treatment algorithm for Palmer type IB tears.

    PubMed

    Atzei, A; Luchetti, R; Garagnani, L

    2017-05-01

    The classical definition of 'Palmer Type IB' triangular fibrocartilage complex tear, includes a spectrum of clinical conditions. This review highlights the clinical and arthroscopic criteria that enable us to categorize five classes on a treatment-oriented classification system of triangular fibrocartilage complex peripheral tears. Class 1 lesions represent isolated tears of the distal triangular fibrocartilage complex without distal radio-ulnar joint instability and are amenable to arthroscopic suture. Class 2 tears include rupture of both the distal triangular fibrocartilage complex and proximal attachments of the triangular fibrocartilage complex to the fovea. Class 3 tears constitute isolated ruptures of the proximal attachment of the triangular fibrocartilage complex to the fovea; they are not visible at radio-carpal arthroscopy. Both Class 2 and Class 3 tears are diagnosed with a positive hook test and are typically associated with distal radio-ulnar joint instability. If required, treatment is through reattachment of the distal radio-ulnar ligament insertions to the fovea. Class 4 lesions are irreparable tears due to the size of the defect or to poor tissue quality and, if required, treatment is through distal radio-ulnar ligament reconstruction with tendon graft. Class 5 tears are associated with distal radio-ulnar joint arthritis and can only be treated with salvage procedures. This subdivision of type IB triangular fibrocartilage complex tear provides more insights in the pathomechanics and treatment strategies. II.

  7. Evidence report: Genetic and metabolic testing on children with global developmental delay: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society.

    PubMed

    Michelson, D J; Shevell, M I; Sherr, E H; Moeschler, J B; Gropman, A L; Ashwal, S

    2011-10-25

    To systematically review the evidence concerning the diagnostic yield of genetic and metabolic evaluation of children with global developmental delay or intellectual disability (GDD/ID). Relevant literature was reviewed, abstracted, and classified according to the 4-tiered American Academy of Neurology classification of evidence scheme. In patients with GDD/ID, microarray testing is diagnostic on average in 7.8% (Class III), G-banded karyotyping is abnormal in at least 4% (Class II and III), and subtelomeric fluorescence in situ hybridization is positive in 3.5% (Class I, II, and III). Testing for X-linked ID genes has a yield of up to 42% in males with an appropriate family history (Class III). FMR1 testing shows full expansion in at least 2% of patients with mild to moderate GDD/ID (Class II and III), and MeCP2 testing is diagnostic in 1.5% of females with moderate to severe GDD/ID (Class III). Tests for metabolic disorders have a yield of up to 5%, and tests for congenital disorders of glycosylation and cerebral creatine disorders have yields of up to 2.8% (Class III). Several genetic and metabolic screening tests have been shown to have a better than 1% diagnostic yield in selected populations of children with GDD/ID. These values should be among the many factors considered in planning the laboratory evaluation of such children.

  8. Evaluation of arch form between Vietnamese and North American Caucasians using 3-dimensional virtual models.

    PubMed

    Trang, Vu Thi Thu; Park, Jae Hyun; Bayome, Mohamed; Shastry, Shruti; Mellion, Alex; Kook, Yoon-Ah

    2015-01-01

    The purpose of this study was to investigate the three-dimensional (3D) morphologic differences in the mandibular arch of Vietnamese and North American White subjects. The sample included 113 Vietnamese subjects (41 Class I, 37 Class II and 35 Class III) and 96 White subjects (29 Class I, 30 Class II and 37 Class III). The samples were regrouped according to arch form types (tapered, ovoid, and square) to compare the frequency distribution of the three arch forms between ethnic groups in each angle classification. The facial axis point of each tooth was digitized on 3D virtual models. Four linear and two ratio variables were measured. In comparing arch dimensions, the intercanine and intermolar widths were wider in Vietnamese than in Whites (p < 0.001, p = 0.042, respectively). In the White group, there was even frequency distribution of the three arch forms. However, in the Vietnamese group, the square arch form was the most frequent followed by tapered and ovoid arch forms. The arch forms of Whites were narrower than Vietnamese. In North American Whites, the distribution of the arch form types showed similar frequency. In Vietnamese, the square arch form was more frequent.

  9. Determination of Classification Accuracy for Land Use/cover Types Using Landsat-Tm Spot-Mss and Multipolarized and Multi-Channel Synthetic Aperture Radar

    NASA Astrophysics Data System (ADS)

    Dondurur, Mehmet

    The primary objective of this study was to determine the degree to which modern SAR systems can be used to obtain information about the Earth's vegetative resources. Information obtainable from microwave synthetic aperture radar (SAR) data was compared with that obtainable from LANDSAT-TM and SPOT data. Three hypotheses were tested: (a) Classification of land cover/use from SAR data can be accomplished on a pixel-by-pixel basis with the same overall accuracy as from LANDSAT-TM and SPOT data. (b) Classification accuracy for individual land cover/use classes will differ between sensors. (c) Combining information derived from optical and SAR data into an integrated monitoring system will improve overall and individual land cover/use class accuracies. The study was conducted with three data sets for the Sleeping Bear Dunes test site in the northwestern part of Michigan's lower peninsula, including an October 1982 LANDSAT-TM scene, a June 1989 SPOT scene and C-, L- and P-Band radar data from the Jet Propulsion Laboratory AIRSAR. Reference data were derived from the Michigan Resource Information System (MIRIS) and available color infrared aerial photos. Classification and rectification of data sets were done using ERDAS Image Processing Programs. Classification algorithms included Maximum Likelihood, Mahalanobis Distance, Minimum Spectral Distance, ISODATA, Parallelepiped, and Sequential Cluster Analysis. Classified images were rectified as necessary so that all were at the same scale and oriented north-up. Results were analyzed with contingency tables and percent correctly classified (PCC) and Cohen's Kappa (CK) as accuracy indices using CSLANT and ImagePro programs developed for this study. Accuracy analyses were based upon a 1.4 by 6.5 km area with its long axis east-west. Reference data for this subscene total 55,770 15 by 15 m pixels with sixteen cover types, including seven level III forest classes, three level III urban classes, two level II range classes, two water classes, one wetland class and one agriculture class. An initial analysis was made without correcting the 1978 MIRIS reference data to the different dates of the TM, SPOT and SAR data sets. In this analysis, highest overall classification accuracy (PCC) was 87% with the TM data set, with both SPOT and C-Band SAR at 85%, a difference statistically significant at the 0.05 level. When the reference data were corrected for land cover change between 1978 and 1991, classification accuracy with the C-Band SAR data increased to 87%. Classification accuracy differed from sensor to sensor for individual land cover classes, Combining sensors into hypothetical multi-sensor systems resulted in higher accuracies than for any single sensor. Combining LANDSAT -TM and C-Band SAR yielded an overall classification accuracy (PCC) of 92%. The results of this study indicate that C-Band SAR data provide an acceptable substitute for LANDSAT-TM or SPOT data when land cover information is desired of areas where cloud cover obscures the terrain. Even better results can be obtained by integrating TM and C-Band SAR data into a multi-sensor system.

  10. Gender, Race, and Survival: A Study in Non-Small-Cell Lung Cancer Brain Metastases Patients Utilizing the Radiation Therapy Oncology Group Recursive Partitioning Analysis Classification

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Videtic, Gregory M.M., E-mail: videtig@ccf.or; Reddy, Chandana A.; Chao, Samuel T.

    Purpose: To explore whether gender and race influence survival in non-small-cell lung cancer (NSCLC) in patients with brain metastases, using our large single-institution brain tumor database and the Radiation Therapy Oncology Group recursive partitioning analysis (RPA) brain metastases classification. Methods and materials: A retrospective review of a single-institution brain metastasis database for the interval January 1982 to September 2004 yielded 835 NSCLC patients with brain metastases for analysis. Patient subsets based on combinations of gender, race, and RPA class were then analyzed for survival differences. Results: Median follow-up was 5.4 months (range, 0-122.9 months). There were 485 male patients (M)more » (58.4%) and 346 female patients (F) (41.6%). Of the 828 evaluable patients (99%), 143 (17%) were black/African American (B) and 685 (83%) were white/Caucasian (W). Median survival time (MST) from time of brain metastasis diagnosis for all patients was 5.8 months. Median survival time by gender (F vs. M) and race (W vs. B) was 6.3 months vs. 5.5 months (p = 0.013) and 6.0 months vs. 5.2 months (p = 0.08), respectively. For patients stratified by RPA class, gender, and race, MST significantly favored BFs over BMs in Class II: 11.2 months vs. 4.6 months (p = 0.021). On multivariable analysis, significant variables were gender (p = 0.041, relative risk [RR] 0.83) and RPA class (p < 0.0001, RR 0.28 for I vs. III; p < 0.0001, RR 0.51 for II vs. III) but not race. Conclusions: Gender significantly influences NSCLC brain metastasis survival. Race trended to significance in overall survival but was not significant on multivariable analysis. Multivariable analysis identified gender and RPA classification as significant variables with respect to survival.« less

  11. Compensation trends of the angulation of first molars: retrospective study of 1403 malocclusion cases.

    PubMed

    Su, Hong; Han, Bing; Li, Sa; Na, Bin; Ma, Wen; Xu, Tian-Min

    2014-09-01

    We investigated the compensatory trends of mesiodistal angulation of first molars in malocclusion cases. We compared differences in the angulation of first molars in different developmental stages, malocclusion classifications and skeletal patterns. The medical records and lateral cephalogrammes of 1403 malocclusion cases taken before treatment were measured to evaluate compensation of molar angulation in relation to the skeletal jaw. The cases were stratified by age, Angle classification and skeletal patterns. Differences in the mesiodistal angulation of the first molars were compared among the stratifications. We observed three main phenomena. First, angulation of the upper first molar varied significantly with age and tipped most distally in cases aged <12 years and least distally in cases aged >16 years. The lower first molar did not show such differences. Second, in Angle Class II or skeletal Class II cases, the upper first molar was the most distally tipped, the lower first molar was the most mesially tipped, and opposite angulation compensation was observed in Class III cases. Third, in high-angle cases, the upper and lower first molars were the most distally tipped, and opposite angulation compensation was observed in low-angle cases. These data suggest that the angulation of the molars compensated for various growth patterns and malocclusion types. Hence, awareness of molar angulation compensation would help to adjust occlusal relationships, control anchorage and increase the chances of long-term stability.

  12. Guidelines for acute ischemic stroke treatment: part II: stroke treatment.

    PubMed

    Martins, Sheila Cristina Ouriques; Freitas, Gabriel Rodriguez de; Pontes-Neto, Octávio Marques; Pieri, Alexandre; Moro, Carla Heloísa Cabral; Jesus, Pedro Antônio Pereira de; Longo, Alexandre; Evaristo, Eli Faria; Carvalho, João José Freitas de; Fernandes, Jefferson Gomes; Gagliardi, Rubens José; Oliveira-Filho, Jamary

    2012-11-01

    The second part of these Guidelines covers the topics of antiplatelet, anticoagulant, and statin therapy in acute ischemic stroke, reperfusion therapy, and classification of Stroke Centers. Information on the classes and levels of evidence used in this guideline is provided in Part I. A translated version of the Guidelines is available from the Brazilian Stroke Society website (www.sbdcv.com.br).

  13. A comprehensive classification of galaxies in the Sloan Digital Sky Survey: how to tell true from fake AGN?

    NASA Astrophysics Data System (ADS)

    Cid Fernandes, R.; Stasińska, G.; Mateus, A.; Vale Asari, N.

    2011-05-01

    We use the WHα versus [N II]/Hα (WHAN) diagram introduced by us in previous work to provide a comprehensive emission-line classification of Sloan Digital Sky Survey galaxies. This classification is able to cope with the large population of weak line galaxies that do not appear in traditional diagrams due to a lack of some of the diagnostic lines. A further advantage of the WHAN diagram is to allow the differentiation between two very distinct classes that overlap in the low-ionization nuclear emission-line region (LINER) region of traditional diagnostic diagrams. These are galaxies hosting a weakly active galactic nucleus (wAGN) and 'retired galaxies' (RGs), i.e. galaxies that have stopped forming stars and are ionized by their hot low-mass evolved stars. A useful criterion to distinguish true from fake AGN (i.e. the RGs) is the value of ξ, which measures the ratio of the extinction-corrected Hα luminosity with respect to the Hα luminosity expected from photoionization by stellar populations older than 108 yr. We find that ξ follows a markedly bimodal distribution, with a ξ≫ 1 population composed by systems undergoing star formation and/or nuclear activity, and a peak at ξ˜ 1 corresponding to the prediction of the RG model. We base our classification scheme not on ξ but on a more readily available and model-independent quantity which provides an excellent observational proxy for ξ: the equivalent width of Hα. Based on the bimodal distribution of WHα, we set the practical division between wAGN and RGs at WHα= 3 Å. Five classes of galaxies are identified within the WHAN diagram: (i) pure star-forming galaxies: ? and WHα > 3 Å; (ii) strong AGN (i.e. Seyferts): ? and WHα > 6 Å; (iii) weak AGN: ? and WHα between 3 and 6 Å; (iv) RGs (i.e. fake AGN): WHα < 3 Å; (v) passive galaxies (actually, lineless galaxies): WHα and W[N II] < 0.5 Å. A comparative analysis of star formation histories and of other physical and observational properties in these different classes of galaxies corroborates our proposed differentiation between RGs and wAGN in the LINER-like family. This analysis also shows similarities between strong and weak AGN on the one hand, and retired and passive galaxies on the other.

  14. A 2-d classification of diseases based on age-specific death rates

    NASA Astrophysics Data System (ADS)

    Richmond, Peter; Roehner, Bertrand M.

    2018-02-01

    Age specific mortality curves exhibit an age tc (about 10 years) which plays a crucial role in that the mortality curve decreases hyperbolically in the age interval A before tc and increases exponentially in the interval B following tc. For those familiar with reliability theory, region A is called the "burn in" phase and B is the "wear out" phase. Using the exponents of the hyperbolic and exponential phases, we introduce a new 2 dimensional map of diseases. This permits the classification of diseases into three broad classes: AS1, AS2 and S. Class AS1 includes all diseases arising from congenital malformations which dominate infant and child mortality; class AS2 includes degenerative diseases such as dementia and Alzheimer's which dominate old age mortality. In class S, which includes most infectious and metabolic diseases, the exponents from both aging phases contribute to positions on the map. Cancer is one of these mixed cases but is closer to class AS2 than AS1. A second line classification is needed to resolve S cases and to this end we introduce a 3rd dimension, namely (calendar) time. Using historical data we show that in their response to treatment (particularly vaccination), S diseases fall into three sub-classes. (i) Class E diseases (e.g. measles or meningococcal disease) which have been almost eliminated at all ages (ii) class C diseases (e.g. tuberculosis) which can be cured but whose cure becomes less effective at old age. (iii) Class U diseases for which radical cures are still unknown. Regarding the future, the fact that the wear-out process of numerous diseases already starts around the age of 25 means that a major extension of the human lifespan beyond 120 certainly also requires to uncover the secret of the "elixir of eternal youth" which has driven timeless human efforts and still seems unlikely in the foreseeable future.

  15. A heuristic multi-criteria classification approach incorporating data quality information for choropleth mapping

    PubMed Central

    Sun, Min; Wong, David; Kronenfeld, Barry

    2016-01-01

    Despite conceptual and technology advancements in cartography over the decades, choropleth map design and classification fail to address a fundamental issue: estimates that are statistically indifferent may be assigned to different classes on maps or vice versa. Recently, the class separability concept was introduced as a map classification criterion to evaluate the likelihood that estimates in two classes are statistical different. Unfortunately, choropleth maps created according to the separability criterion usually have highly unbalanced classes. To produce reasonably separable but more balanced classes, we propose a heuristic classification approach to consider not just the class separability criterion but also other classification criteria such as evenness and intra-class variability. A geovisual-analytic package was developed to support the heuristic mapping process to evaluate the trade-off between relevant criteria and to select the most preferable classification. Class break values can be adjusted to improve the performance of a classification. PMID:28286426

  16. Genome-wide identification and expression analysis of the ClTCP transcription factors in Citrullus lanatus.

    PubMed

    Shi, Pibiao; Guy, Kateta Malangisha; Wu, Weifang; Fang, Bingsheng; Yang, Jinghua; Zhang, Mingfang; Hu, Zhongyuan

    2016-04-12

    The plant-specific TCP transcription factor family, which is involved in the regulation of cell growth and proliferation, performs diverse functions in multiple aspects of plant growth and development. However, no comprehensive analysis of the TCP family in watermelon (Citrullus lanatus) has been undertaken previously. A total of 27 watermelon TCP encoding genes distributed on nine chromosomes were identified. Phylogenetic analysis clustered the genes into 11 distinct subgroups. Furthermore, phylogenetic and structural analyses distinguished two homology classes within the ClTCP family, designated Class I and Class II. The Class II genes were differentiated into two subclasses, the CIN subclass and the CYC/TB1 subclass. The expression patterns of all members were determined by semi-quantitative PCR. The functions of two ClTCP genes, ClTCP14a and ClTCP15, in regulating plant height were confirmed by ectopic expression in Arabidopsis wild-type and ortholog mutants. This study represents the first genome-wide analysis of the watermelon TCP gene family, which provides valuable information for understanding the classification and functions of the TCP genes in watermelon.

  17. The evolution of flaring and non-flaring active regions

    NASA Astrophysics Data System (ADS)

    Kilcik, A.; Yurchyshyn, V.; Sahin, S.; Sarp, V.; Obridko, V.; Ozguc, A.; Rozelot, J. P.

    2018-06-01

    According to the modified Zurich classification, sunspot groups are classified into seven different classes (A, B, C, D, E, F and H) based on their morphology and evolution. In this classification, classes A and B, which are small groups, describe the beginning of sunspot evolution, while classes D, E and F describe the large and evolved groups. Class C describes the middle phase of sunspot evolution and the class H describes the end of sunspot evolution. Here, we compare the lifetime and temporal evolution of flaring and non-flaring active regions (ARs), and the flaring effect on ARs in these groups in detail for the last two solar cycles (1996 through 2016). Our main findings are as follows: (i) Flaring sunspot groups have longer lifetimes than non-flaring ones. (ii) Most of the class A, B and C flaring ARs rapidly evolve to higher classes, while this is not applicable for non-flaring ARs. More than 50 per cent of the flaring A, B and C groups changed morphologically, while the remaining D, E, F and H groups did not change remarkably after the flare activity. (iii) 75 per cent of all flaring sunspot groups are large and complex. (iv) There is a significant increase in the sunspot group area in classes A, B, C, D and H after flaring activity. In contrast, the sunspot group area of classes E and F decreased. The sunspot counts of classes D, E and F decreased as well, while classes A, B, C and H showed an increase.

  18. 32 CFR 1642.2 - The claim for classification in Class 3-A.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... SYSTEM CLASSIFICATION OF REGISTRANTS DEFERRED BECAUSE OF HARDSHIP TO DEPENDENTS § 1642.2 The claim for classification in Class 3-A. A claim for classification in Class 3-A must be made by the registrant in writing... 32 National Defense 6 2010-07-01 2010-07-01 false The claim for classification in Class 3-A. 1642...

  19. 32 CFR 1642.2 - The claim for classification in Class 3-A.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... SYSTEM CLASSIFICATION OF REGISTRANTS DEFERRED BECAUSE OF HARDSHIP TO DEPENDENTS § 1642.2 The claim for classification in Class 3-A. A claim for classification in Class 3-A must be made by the registrant in writing... 32 National Defense 6 2011-07-01 2011-07-01 false The claim for classification in Class 3-A. 1642...

  20. Crystallization tendency of active pharmaceutical ingredients following rapid solvent evaporation--classification and comparison with crystallization tendency from undercooled melts.

    PubMed

    Van Eerdenbrugh, Bernard; Baird, Jared A; Taylor, Lynne S

    2010-09-01

    In this study, the crystallization behavior of a variety of compounds was studied following rapid solvent evaporation using spin coating. Initial screening to determine model compound suitability was performed using a structurally diverse set of 51 compounds in three different solvent systems [dichloromethane (DCM), a 1:1 (w/w) dichloromethane/ethanol mixture (MIX), and ethanol (EtOH)]. Of this starting set of 153 drug-solvent combinations, 93 (40 compounds) were selected for further evaluation based on solubility, chemical solution stability, and processability criteria. These systems were spin coated and their crystallization was monitored using polarized light microscopy (7 days, dry conditions). The crystallization behavior of the samples could be classified as rapid (Class I: 39 cases), intermediate (Class II: 23 cases), or slow (Class III: 31 cases). The solvent system employed influenced the classification outcome for only four of the compounds. The various compounds showed very diverse crystallization behavior. Upon comparison of classification results with those of a previous study, where cooling from the melt was used as a preparation technique, a good similarity was found whereby 68% of the cases were identically classified. Multivariate analysis was performed using a set of relevant physicochemical compound characteristics. It was found that a number of these parameters tended to differ between the different classes. These could be further interpreted in terms of the nature of the crystallization process. Additional multivariate analysis on the separate classes of compounds indicated some potential in predicting the crystallization tendency of a given compound.

  1. Phylogenetic analysis, subcellular localization, and expression patterns of RPD3/HDA1 family histone deacetylases in plants

    PubMed Central

    Alinsug, Malona V; Yu, Chun-Wei; Wu, Keqiang

    2009-01-01

    Background Although histone deacetylases from model organisms have been previously identified, there is no clear basis for the classification of histone deacetylases under the RPD3/HDA1 superfamily, particularly on plants. Thus, this study aims to reconstruct a phylogenetic tree to determine evolutionary relationships between RPD3/HDA1 histone deacetylases from six different plants representing dicots with Arabidopsis thaliana, Populus trichocarpa, and Pinus taeda, monocots with Oryza sativa and Zea mays, and the lower plants with Physcomitrella patens. Results Sixty two histone deacetylases of RPD3/HDA1 family from the six plant species were phylogenetically analyzed to determine corresponding orthologues. Three clusters were formed separating Class I, Class II, and Class IV. We have confirmed lower and higher plant orthologues for AtHDA8 and AtHDA14, classifying both genes as Class II histone deacetylases in addition to AtHDA5, AtHDA15, and AtHDA18. Since Class II histone deacetylases in other eukaryotes have been known to undergo nucleocytoplasmic transport, it remains unknown whether such functional regulation also happens in plants. Thus, bioinformatics studies using different programs and databases were conducted to predict their corresponding localization sites, nuclear export signal, nuclear localization signal, as well as expression patterns. We also found new conserved domains in most of the RPD3/HDA1 histone deacetylases which were similarly conserved in its corresponding orthologues. Assessing gene expression patterns using Genevestigator, it appears that RPD3/HDA1 histone deacetylases are expressed all throughout the plant parts and developmental stages of the plant. Conclusion The RPD3/HDA1 histone deacetylase family in plants is divided into three distinct groups namely, Class I, Class II, and Class IV suggesting functional diversification. Class II comprises not only AtHDA5, AtHDA15, and AtHDA18 but also includes AtHDA8 and AtHDA14. New conserved domains have also been identified in most of the RPD3/HDA1 family indicating further versatile roles other than histone deacetylation. PMID:19327164

  2. Plasma lipophilic antioxidants and malondialdehyde in congestive heart failure patients: relationship to disease severity.

    PubMed

    Polidori, Maria Cristina; Savino, Ketty; Alunni, Gianfranco; Freddio, Michela; Senin, Umberto; Sies, Helmut; Stahl, Wilhelm; Mecocci, Patrizia

    2002-01-15

    Plasma levels of malondialdehyde (MDA), vitamin A, and of antioxidant micronutrients including vitamin E, lutein, zeaxanthin, beta-cryptoxanthin, lycopene, and alpha- and beta-carotene were measured in 30 patients with class II and III congestive heart failure (CHF) according to the New York Heart Association (NYHA) classification and in 55 controls. Ejection fraction was evaluated by echocardiography in all patients as a measure of the emptying capacity of the heart. Plasma levels of all measured compounds were significantly lower and MDA significantly higher in patients compared to controls (p <.001). Class II NYHA patients showed significantly lower MDA levels and significantly higher levels of vitamin A, vitamin E, lutein, and lycopene than class III patients. Ejection fraction was inversely correlated with MDA levels and directly correlated with vitamin A, vitamin E, lutein, and lycopene levels in patients. The present study supports the concept that an increased consumption of vitamin-rich fruits and vegetables might help in achieving cardiovascular health.

  3. Evidence-based medicine and contemporary certification: Analysis of the American Board of Vascular Medicine endovascular board examination.

    PubMed

    Slovut, David Paul; Gray, Bruce H; Saiar, Amin; Bates, Mark C

    2017-08-01

    Since 2005, the American Board of Vascular Medicine (ABVM) endovascular examination has been used to certify vascular practitioners. Annual rigorous review has confirmed it is psychometrically valid and reliable. However, the evidence basis underlying the examination items has not been studied systematically. The aim of this study was to adjudicate class of recommendation (COR) and level of evidence (LOE) for the 2015 ABVM endovascular examination and establish an additional feedback mechanism for examination improvement based on contemporary evidence-based guidelines. We performed a pooled consensus process to classify each of the 110 items in the 2015 ABVM endovascular examination by COR and LOE as detailed in the current guideline statements. We added additional categories for items that were not eligible for assignment using traditional current evidence-based metrics: 'COR X', cannot be determined, not applicable, or simple recognition; and 'LOE X', cannot be determined or not applicable. COR classifications were assigned in the following proportion: Class I=15%, Class II=40%, Class III=3%, COR X=42%. LOE classifications were assigned in the following proportion: Level A=12%, Level B=34%, Level C=32%, LOE X=22%. Our analysis showed that nearly half of the 2015 ABVM endovascular examination items were supported by strong scientific evidence or fact-based knowledge. COR and LOE analysis yielded notably different results. Use of alternate classification schema may be powerful tools for improving certification exams in healthcare.

  4. Analysis of spatial distribution of land cover maps accuracy

    NASA Astrophysics Data System (ADS)

    Khatami, R.; Mountrakis, G.; Stehman, S. V.

    2017-12-01

    Land cover maps have become one of the most important products of remote sensing science. However, classification errors will exist in any classified map and affect the reliability of subsequent map usage. Moreover, classification accuracy often varies over different regions of a classified map. These variations of accuracy will affect the reliability of subsequent analyses of different regions based on the classified maps. The traditional approach of map accuracy assessment based on an error matrix does not capture the spatial variation in classification accuracy. Here, per-pixel accuracy prediction methods are proposed based on interpolating accuracy values from a test sample to produce wall-to-wall accuracy maps. Different accuracy prediction methods were developed based on four factors: predictive domain (spatial versus spectral), interpolation function (constant, linear, Gaussian, and logistic), incorporation of class information (interpolating each class separately versus grouping them together), and sample size. Incorporation of spectral domain as explanatory feature spaces of classification accuracy interpolation was done for the first time in this research. Performance of the prediction methods was evaluated using 26 test blocks, with 10 km × 10 km dimensions, dispersed throughout the United States. The performance of the predictions was evaluated using the area under the curve (AUC) of the receiver operating characteristic. Relative to existing accuracy prediction methods, our proposed methods resulted in improvements of AUC of 0.15 or greater. Evaluation of the four factors comprising the accuracy prediction methods demonstrated that: i) interpolations should be done separately for each class instead of grouping all classes together; ii) if an all-classes approach is used, the spectral domain will result in substantially greater AUC than the spatial domain; iii) for the smaller sample size and per-class predictions, the spectral and spatial domain yielded similar AUC; iv) for the larger sample size (i.e., very dense spatial sample) and per-class predictions, the spatial domain yielded larger AUC; v) increasing the sample size improved accuracy predictions with a greater benefit accruing to the spatial domain; and vi) the function used for interpolation had the smallest effect on AUC.

  5. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies.

    PubMed

    Grimbizis, Grigoris F; Gordts, Stephan; Di Spiezio Sardo, Attilio; Brucker, Sara; De Angelis, Carlo; Gergolet, Marco; Li, Tin-Chiu; Tanos, Vasilios; Brölmann, Hans; Gianaroli, Luca; Campo, Rudi

    2013-08-01

    What classification system is more suitable for the accurate, clear, simple and related to the clinical management categorization of female genital anomalies? The new ESHRE/ESGE classification system of female genital anomalies is presented. Congenital malformations of the female genital tract are common miscellaneous deviations from normal anatomy with health and reproductive consequences. Until now, three systems have been proposed for their categorization but all of them are associated with serious limitations. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) have established a common Working Group, under the name CONUTA (CONgenital UTerine Anomalies), with the goal of developing a new updated classification system. A scientific committee (SC) has been appointed to run the project, looking also for consensus within the scientists working in the field. The new system is designed and developed based on (i) scientific research through critical review of current proposals and preparation of an initial proposal for discussion between the experts, (ii) consensus measurement among the experts through the use of the DELPHI procedure and (iii) consensus development by the SC, taking into account the results of the DELPHI procedure and the comments of the experts. Almost 90 participants took part in the process of development of the ESHRE/ESGE classification system, contributing with their structured answers and comments. The ESHRE/ESGE classification system is based on anatomy. Anomalies are classified into the following main classes, expressing uterine anatomical deviations deriving from the same embryological origin: U0, normal uterus; U1, dysmorphic uterus; U2, septate uterus; U3, bicorporeal uterus; U4, hemi-uterus; U5, aplastic uterus; U6, for still unclassified cases. Main classes have been divided into sub-classes expressing anatomical varieties with clinical significance. Cervical and vaginal anomalies are classified independently into sub-classes having clinical significance. The ESHRE/ESGE classification of female genital anomalies seems to fulfill the expectations and the needs of the experts in the field, but its clinical value needs to be proved in everyday practice. The ESHRE/ESGE classification system of female genital anomalies could be used as a starting point for the development of guidelines for their diagnosis and treatment. None.

  6. Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure. Final order.

    PubMed

    2016-02-12

    The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (<=6 hours), such device or accessory will be subject to the same regulatory controls applied to the oxygenator (i.e., class II, special controls) when evaluated as part of the ECMO circuit for long-term use (>6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.

  7. Compensation trends of the angulation of first molars: retrospective study of 1 403 malocclusion cases

    PubMed Central

    Su, Hong; Han, Bing; Li, Sa; Na, Bin; Ma, Wen; Xu, Tian-Min

    2014-01-01

    We investigated the compensatory trends of mesiodistal angulation of first molars in malocclusion cases. We compared differences in the angulation of first molars in different developmental stages, malocclusion classifications and skeletal patterns. The medical records and lateral cephalogrammes of 1 403 malocclusion cases taken before treatment were measured to evaluate compensation of molar angulation in relation to the skeletal jaw. The cases were stratified by age, Angle classification and skeletal patterns. Differences in the mesiodistal angulation of the first molars were compared among the stratifications. We observed three main phenomena. First, angulation of the upper first molar varied significantly with age and tipped most distally in cases aged <12 years and least distally in cases aged >16 years. The lower first molar did not show such differences. Second, in Angle Class II or skeletal Class II cases, the upper first molar was the most distally tipped, the lower first molar was the most mesially tipped, and opposite angulation compensation was observed in Class III cases. Third, in high-angle cases, the upper and lower first molars were the most distally tipped, and opposite angulation compensation was observed in low-angle cases. These data suggest that the angulation of the molars compensated for various growth patterns and malocclusion types. Hence, awareness of molar angulation compensation would help to adjust occlusal relationships, control anchorage and increase the chances of long-term stability. PMID:24699185

  8. 32 CFR 1642.3 - Basis for classification in Class 3-A.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 6 2011-07-01 2011-07-01 false Basis for classification in Class 3-A. 1642.3... CLASSIFICATION OF REGISTRANTS DEFERRED BECAUSE OF HARDSHIP TO DEPENDENTS § 1642.3 Basis for classification in... registrant for classification in Class 3-A, the board will first determine whether the registrant's wife...

  9. Objectification of Orthodontic Treatment Needs: Does the Classification of Malocclusions or a History of Orthodontic Treatment Matter?

    PubMed

    Kozanecka, Anna; Sarul, Michał; Kawala, Beata; Antoszewska-Smith, Joanna

    2016-01-01

    Orthodontic classifications make it possible to give an accurate diagnosis but do not indicate an objective orthodontic treatment need. In order to evaluate the need for treatment, it is necessary to use such indicators as the IOTN. The aim of the study was to find (i) relationships between individual diagnosis and objective recommendations for treatment and (ii) an answer to the question whether and which occlusal anomalies play an important role in the objectification of treatment needs. Two hundred three 18-year-old adolescents (104 girls, 99 boys) were examined. In order to recognize occlusal anomalies, the classifications proposed by Orlik-Grzybowska and Ackerman-Proffit were used. The occlusal anomalies were divided into three categories: belonging to both classifications, typical of OrlikGrzybowska classification and typical of Ackerman-Proffit classification. In order to determine the objective need for orthodontic treatment, the Dental Health Component (DHC) of the IOTN was used. The occurrence of the following malocclusions covered by both classifications, namely abnormal overjet, crossbite and Angle's class, had a statistically significant (p < 0.05) impact on an increase of treatment needs in the subjects (DHC > 3). As for the classification by Orlik-Grzybowska, dental malpositions and canine class significantly affected the need for orthodontic treatment, while in the case of the Ackerman-Proffit scheme, it was asymmetry and crowding. There was no statistically significant correlation between past orthodontic treatment and current orthodontic treatment need. IOTN may be affected by a greater number of occlusal anomalies than it was assumed. Orthodontic treatment received in the past slightly reduces the need for treatment in 18-year-olds.

  10. 14 CFR Sec. 19-4 - Service classes.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... a composite of first class, coach, and mixed passenger/cargo service. The following classifications... integral part of services performed pursuant to published flight schedules. The following classifications... Classifications Sec. 19-4 Service classes. The statistical classifications are designed to reflect the operating...

  11. 14 CFR Sec. 19-4 - Service classes.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... a composite of first class, coach, and mixed passenger/cargo service. The following classifications... integral part of services performed pursuant to published flight schedules. The following classifications... Classifications Sec. 19-4 Service classes. The statistical classifications are designed to reflect the operating...

  12. Is Obesity a Risk Factor for Adverse Events After Knee Arthroscopy?

    PubMed

    Sing, David C; Luan, Tammy F; Feeley, Brian T; Zhang, Alan L

    2016-07-01

    To evaluate how body mass index (BMI) affects rates of 30-day complication, hospital readmissions, and mortality in patients undergoing knee arthroscopy. Patients undergoing knee arthroscopy procedures between 2006 and 2013 were identified in the American College of Surgeons National Surgical Quality Improvement Program database. Patient demographics and preoperative risk factors including BMI were analyzed for postoperative complications within 30 days. Cochran-Armitage testing was performed to detect differences in complication rates across BMI categories according to World Health Organization classification. The independent risk of BMI was assessed using multivariate regression analysis. Of 41,919 patients with mean age 48 years undergoing knee arthroscopy, 20% were classified as normal weight (BMI 18.5 to 24), 35% overweight (BMI 25 to 29), 24% obese class I (BMI 30 to 34), 12% class II (BMI 35 to 40), and 9% class III (BMI ≥40). Risk of complication increased significantly with increasing BMI (normal: 1.5%, overweight: 1.6%, obese class I: 1.7%, obese class II: 1.8%, obese class III: 1.9%, P = .043). On multivariate analysis, there was no increased risk of postoperative complication directly attributed to patient BMI. Independent risk factors for medical and surgical complications after knee arthroscopy included American Society of Anesthesiologists (ASA) rating (class 4 v class 1 odds ratio [OR]: 5.39 [95% confidence interval: 3.11-9.33], P < .001), functional status for activities of daily living (dependent v independent OR: 2.13 [1.42, 3.31], P < .001), history of renal comorbidity (presence v absence OR: 5.10 [2.30, 11.29], P < .001), and previously experienced history of wound infection prior to current surgery (presence v absence OR: 4.91 [2.88, 8.39], P < .001). More than 40% of knee arthroscopy patients qualify as obese. Although univariate analysis suggests that obesity is associated with increased postoperative complications within 30 days of surgery, BMI alone does not predict complications. Independent predictors of complications include patients with high ASA classification, dependent functional status, renal comorbidities, and a recent history of wound infection. Level IV, prognostic case series. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  13. Early warning, warning or alarm systems for natural hazards? A generic classification.

    NASA Astrophysics Data System (ADS)

    Sättele, Martina; Bründl, Michael; Straub, Daniel

    2013-04-01

    Early warning, warning and alarm systems have gained popularity in recent years as cost-efficient measures for dangerous natural hazard processes such as floods, storms, rock and snow avalanches, debris flows, rock and ice falls, landslides, flash floods, glacier lake outburst floods, forest fires and even earthquakes. These systems can generate information before an event causes loss of property and life. In this way, they mainly mitigate the overall risk by reducing the presence probability of endangered objects. These systems are typically prototypes tailored to specific project needs. Despite their importance there is no recognised system classification. This contribution classifies warning and alarm systems into three classes: i) threshold systems, ii) expert systems and iii) model-based expert systems. The result is a generic classification, which takes the characteristics of the natural hazard process itself and the related monitoring possibilities into account. The choice of the monitoring parameters directly determines the system's lead time. The classification of 52 active systems moreover revealed typical system characteristics for each system class. i) Threshold systems monitor dynamic process parameters of ongoing events (e.g. water level of a debris flow) and incorporate minor lead times. They have a local geographical coverage and a predefined threshold determines if an alarm is automatically activated to warn endangered objects, authorities and system operators. ii) Expert systems monitor direct changes in the variable disposition (e.g crack opening before a rock avalanche) or trigger events (e.g. heavy rain) at a local scale before the main event starts and thus offer extended lead times. The final alarm decision incorporates human, model and organisational related factors. iii) Model-based expert systems monitor indirect changes in the variable disposition (e.g. snow temperature, height or solar radiation that influence the occurrence probability of snow avalanches) or trigger events (e.g. heavy snow fall) to predict spontaneous hazard events in advance. They encompass regional or national measuring networks and satisfy additional demands such as the standardisation of the measuring stations. The developed classification and the characteristics, which were revealed for each class, yield a valuable input to quantifying the reliability of warning and alarm systems. Importantly, this will facilitate to compare them with well-established standard mitigation measures such as dams, nets and galleries within an integrated risk management approach.

  14. Evaluation of gene expression classification studies: factors associated with classification performance.

    PubMed

    Novianti, Putri W; Roes, Kit C B; Eijkemans, Marinus J C

    2014-01-01

    Classification methods used in microarray studies for gene expression are diverse in the way they deal with the underlying complexity of the data, as well as in the technique used to build the classification model. The MAQC II study on cancer classification problems has found that performance was affected by factors such as the classification algorithm, cross validation method, number of genes, and gene selection method. In this paper, we study the hypothesis that the disease under study significantly determines which method is optimal, and that additionally sample size, class imbalance, type of medical question (diagnostic, prognostic or treatment response), and microarray platform are potentially influential. A systematic literature review was used to extract the information from 48 published articles on non-cancer microarray classification studies. The impact of the various factors on the reported classification accuracy was analyzed through random-intercept logistic regression. The type of medical question and method of cross validation dominated the explained variation in accuracy among studies, followed by disease category and microarray platform. In total, 42% of the between study variation was explained by all the study specific and problem specific factors that we studied together.

  15. 32 CFR 1639.3 - Basis for classification in Class 2-D.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Basis for classification in Class 2-D. 1639.3... CLASSIFICATION OF REGISTRANTS PREPARING FOR THE MINISTRY § 1639.3 Basis for classification in Class 2-D. (a) In... maintained for qualification for the deferment. (b) The registrant's classification shall be determined on...

  16. 32 CFR 1639.3 - Basis for classification in Class 2-D.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 6 2011-07-01 2011-07-01 false Basis for classification in Class 2-D. 1639.3... CLASSIFICATION OF REGISTRANTS PREPARING FOR THE MINISTRY § 1639.3 Basis for classification in Class 2-D. (a) In... maintained for qualification for the deferment. (b) The registrant's classification shall be determined on...

  17. Is Mitochondrial Donation Germ-Line Gene Therapy? Classifications and Ethical Implications.

    PubMed

    Newson, Ainsley J; Wrigley, Anthony

    2017-01-01

    The classification of techniques used in mitochondrial donation, including their role as purported germ-line gene therapies, is far from clear. These techniques exhibit characteristics typical of a variety of classifications that have been used in both scientific and bioethics scholarship. This raises two connected questions, which we address in this paper: (i) how should we classify mitochondrial donation techniques?; and (ii) what ethical implications surround such a classification? First, we outline how methods of genetic intervention, such as germ-line gene therapy, are typically defined or classified. We then consider whether techniques of mitochondrial donation fit into these, whether they might do so with some refinement of these categories, or whether they require some other approach to classification. To answer the second question, we discuss the relationship between classification and several key ethical issues arising from mitochondrial donation. We conclude that the properties characteristic of mitochondrial inheritance mean that most mitochondrial donation techniques belong to a new sub-class of genetic modification, which we call 'conditionally inheritable genomic modification' (CIGM). © 2017 John Wiley & Sons Ltd.

  18. A Global Classification System for Catchment Hydrology

    NASA Astrophysics Data System (ADS)

    Woods, R. A.

    2004-05-01

    It is a shocking state of affairs - there is no underpinning scientific taxonomy of catchments. There are widely used global classification systems for climate, river morphology, lakes and wetlands, but for river catchments there exists only a plethora of inconsistent, incomplete regional schemes. By proceeding without a common taxonomy for catchments, freshwater science has missed one of its key developmental stages, and has leapt from definition of phenomena to experiments, theories and models, without the theoretical framework of a classification. I propose the development of a global hierarchical classification system for physical aspects of river catchments, to help underpin physical science in the freshwater environment and provide a solid foundation for classification of river ecosystems. Such a classification scheme can open completely new vistas in hydrology: for example it will be possible to (i) rationally transfer experimental knowledge of hydrological processes between basins anywhere in the world, provided they belong to the same class; (ii) perform meaningful meta-analyses in order to reconcile studies that show inconsistent results (iii) generate new testable hypotheses which involve locations worldwide.

  19. Random forests ensemble classifier trained with data resampling strategy to improve cardiac arrhythmia diagnosis.

    PubMed

    Ozçift, Akin

    2011-05-01

    Supervised classification algorithms are commonly used in the designing of computer-aided diagnosis systems. In this study, we present a resampling strategy based Random Forests (RF) ensemble classifier to improve diagnosis of cardiac arrhythmia. Random forests is an ensemble classifier that consists of many decision trees and outputs the class that is the mode of the class's output by individual trees. In this way, an RF ensemble classifier performs better than a single tree from classification performance point of view. In general, multiclass datasets having unbalanced distribution of sample sizes are difficult to analyze in terms of class discrimination. Cardiac arrhythmia is such a dataset that has multiple classes with small sample sizes and it is therefore adequate to test our resampling based training strategy. The dataset contains 452 samples in fourteen types of arrhythmias and eleven of these classes have sample sizes less than 15. Our diagnosis strategy consists of two parts: (i) a correlation based feature selection algorithm is used to select relevant features from cardiac arrhythmia dataset. (ii) RF machine learning algorithm is used to evaluate the performance of selected features with and without simple random sampling to evaluate the efficiency of proposed training strategy. The resultant accuracy of the classifier is found to be 90.0% and this is a quite high diagnosis performance for cardiac arrhythmia. Furthermore, three case studies, i.e., thyroid, cardiotocography and audiology, are used to benchmark the effectiveness of the proposed method. The results of experiments demonstrated the efficiency of random sampling strategy in training RF ensemble classification algorithm. Copyright © 2011 Elsevier Ltd. All rights reserved.

  20. Comparison of clinical causes of death with autopsy diagnosis using discrepency classification.

    PubMed

    Ullah, Khalil; Alamgir, Wasim

    2006-12-01

    To determine the usefulness of autopsy findings in the quality improvement of patients care. An observational study. Departments of Pathology and Medicine, Combined Military Hospital (CMH) Kharian, a tertiary care hospital, from January 2001 to December 2003. The clinical and necropsy findings of all the cases, who died in hospital and had undergone autopsy examination at CMH, Kharian, from January 2001 to December 2003, were retrieved from record of clinical case sheet data and autopsy record of the hospital. The two were analyzed and compared according to the discrepancy classification. The exclusion and inclusion criteria, the international classification of disease (ICD) to code deaths, the global burden of disease (GBD) system to classify and group diseases, and the Goldman discrepancy classification to compare clinical and autopsy diagnosis and classify the discrepancies, were used as described. The death rate varied from 0.94% to 1.29% and autopsy rate from 4.69% to 10.10% annually between January 2001 and December 2003. The number of cases classified according to GBD system was 3 (5%) in Group 1, 26 (43.33 %) in Group 2 and 31 (51.66 %) in Group 3. The discrepancy classes included 9 (15 %) class I major discrepancies and 3 (5 %) class II major discrepancies. Non-discrepant diagnosis was seen in 37 cases (61.66 %) and 11 cases (18.32 %) were non-classifiable. This study showed the usefulness of autopsy findings in the quality improvement of the diagnosis and management of the disease by showing only a minority of cases with discrepant diagnosis of the cause of death.

  1. WHO Class of Obesity Influences Functional Recovery Post-TKA.

    PubMed

    Maniar, Rajesh N; Maniar, Parul R; Singhi, Tushar; Gangaraju, Bharat Kumar

    2018-03-01

    No study in the literature has compared early functional recovery following total knee arthroplasty (TKA) in the obese with the nonobese using World Health Organization (WHO) classes of obesity. Our aim was to compare functional scores and flexion post-TKA in each class of obesity as per WHO classification against a matched control group of nonobese patients. Records of 885 consecutive primary TKA patients (919 knees) operated by a single surgeon were reviewed. The first 35 knees in each class I, class II and class III obesity group during the study period were then matched with a similar number of knees in nonobese TKA patients during the same period. Functional scores recorded pre- and postoperatively at 3 months and 1 year were Western Ontario and McMaster Osteoarthritis Index (WOMAC), Short-Form Health Survey (SF-12) score, and Knee Society Score (KSS). There was no difference in any parameter between the class I obese and matched nonobese at any assessment point. In the class II obese, as compared to the nonobese, there was no difference in any parameter preoperatively and 3 months postoperatively. However, 1 year postoperatively, the SF-12 physical subscore was lower in the class II obese than the nonobese (44.7 vs. 48.6, p = 0.047) and the WOMAC score was significantly higher (15.8 vs. 9.7, p = 0.04). In the class III obese, the WOMAC score was significantly higher than the nonobese (58.1 vs. 44.3, p < 0.001 preoperatively; 15.7 vs. 8.1, p = 0.005 at 1 year) and KSS was significantly lower (83.5 vs. 96.5, p = 0.049 preoperatively; 172 vs. 185; p = 0.003 at 1 year). Knee flexion was significantly lower in the class III obese than the nonobese (95 vs. 113; p < 0.001 preoperatively; 120 vs. 127; p = 0.002 at 1 year). The class I obese can expect good early and late functional recovery as the nonobese. The class II obese can expect comparable early functional recovery as the nonobese but their late function may be lesser. The class III obese would have poorer functional scores and lesser knee flexion postoperatively compared to the nonobese. However, compared to their own preoperative status, there is definite improvement in function and knee flexion.

  2. Laser Atherectomy for Treatment of Femoropopliteal In-Stent Restenosis.

    PubMed

    Armstrong, Ehrin J; Thiruvoipati, Thejasvi; Tanganyika, Kundai; Singh, Gagan D; Laird, John R

    2015-08-01

    To investigate if laser atherectomy with adjunctive balloon angioplasty can improve endovascular treatment outcomes for femoropopliteal in-stent restenosis (ISR). A dual center study included 135 symptomatic patients (mean age 71 years; 76 men) who underwent endovascular treatment of femoropopliteal ISR between 2006 and 2013. Of these, 54 (40%) were treated with laser atherectomy and the remaining 81 patients with balloon angioplasty alone. Angiographic images were reviewed for lesion morphology and characteristics, TransAtlantic InterSociety Consensus (TASC) II classification, and distal runoff. Class I ISR was defined as focal lesions ≤50 mm, class II ISR as lesions >50 mm, and class III ISR as stent total occlusion. Recurrent ISR was determined by a peak systolic velocity ratio >2.4 by duplex ultrasound. Patients treated with laser atherectomy had longer mean ISR lesion length (222 vs 114 mm, p<0.001) and more class III ISR (69% vs 20%, p=0.001). There was no association between laser atherectomy and rates of recurrent restenosis or occlusion for patients with class I/II ISR, but there was a significantly lower rate of target lesion revascularization at 2 years among patients treated with laser atherectomy (14% vs 44%, p=0.05). In comparison, patients with class III ISR treated with laser atherectomy had lower rates of recurrent restenosis at 1 year (54% vs 91%, p=0.05) and 2 years (69% vs 100%, p=0.05). Patients with class III ISR treated with laser atherectomy also had lower rates of recurrent in-stent occlusion at 2-year follow-up (33% vs 71%, p=0.04). When used to treat complex ISR, including in-stent occlusions, laser atherectomy with adjunctive balloon angioplasty may be associated with improved patency. © The Author(s) 2015.

  3. YOUNG STELLAR OBJECTS IN THE GOULD BELT

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Dunham, Michael M.; Allen, Lori E.; Evans II, Neal J.

    2015-09-15

    We present the full catalog of Young Stellar Objects (YSOs) identified in the 18 molecular clouds surveyed by the Spitzer Space Telescope “cores to disks” (c2d) and “Gould Belt” (GB) Legacy surveys. Using standard techniques developed by the c2d project, we identify 3239 candidate YSOs in the 18 clouds, 2966 of which survive visual inspection and form our final catalog of YSOs in the GB. We compile extinction corrected spectral energy distributions for all 2966 YSOs and calculate and tabulate the infrared spectral index, bolometric luminosity, and bolometric temperature for each object. We find that 326 (11%), 210 (7%), 1248more » (42%), and 1182 (40%) are classified as Class 0 + I, Flat-spectrum, Class II, and Class III, respectively, and show that the Class III sample suffers from an overall contamination rate by background Asymptotic Giant Branch stars between 25% and 90%. Adopting standard assumptions, we derive durations of 0.40–0.78 Myr for Class 0 + I YSOs and 0.26–0.50 Myr for Flat-spectrum YSOs, where the ranges encompass uncertainties in the adopted assumptions. Including information from (sub)millimeter wavelengths, one-third of the Class 0 + I sample is classified as Class 0, leading to durations of 0.13–0.26 Myr (Class 0) and 0.27–0.52 Myr (Class I). We revisit infrared color–color diagrams used in the literature to classify YSOs and propose minor revisions to classification boundaries in these diagrams. Finally, we show that the bolometric temperature is a poor discriminator between Class II and Class III YSOs.« less

  4. Expressed MHC class II genes in sea otters (Enhydra lutris) from geographically disparate populations

    USGS Publications Warehouse

    Bowen, Lizabeth; Aldridge, B.M.; Miles, A. Keith; Stott, J.L.

    2006-01-01

    The major histocompatibility complex (MHC) is central to maintaining the immunologic vigor of individuals and populations. Classical MHC class II genes were targeted for partial sequencing in sea otters (Enhydra lutris) from populations in California, Washington, and Alaska. Sequences derived from sea otter peripheral blood leukocyte mRNAs were similar to those classified as DQA, DQB, DRA, and DRB in other species. Comparisons of the derived amino acid compositions supported the classification of these as functional molecules from at least one DQA, DQB, and DRA locus and at least two DRB loci. While limited in scope, phylogenetic analysis of the DRB peptide‐binding region suggested the possible existence of distinct clades demarcated by geographic region. These preliminary findings support the need for additional MHC gene sequencing and expansion to a comprehensive study targeting additional otters.

  5. Three-dimensional relativistic jet simulations and the morphological classification of radio-loud AGN

    NASA Astrophysics Data System (ADS)

    Schuh, Terance; Li, Yutong; Elghossain, Geena; Wiita, Paul J.

    2018-06-01

    We have computed a suite of simulations of propagating three-dimensional relativistic jets, involving substantial ranges of initial jet Lorentz factors and ratios of jet density to external medium density. These allow us to categorize the respective AGN into Fanaroff-Riley class I (jet dominated) and FR class II (lobe-dominated) based upon the stability and morphology of the simulations. We used the Athena code to produce a substantial collection of large 3D variations of jets, many of which propagate stably and quickly for over 100 jet radii, but others of which eventually go unstable and fill up slowing advancing lobes. Most of these simulations have jet-to-ambient medium densities between 0.005 and 0.5 and velocities between 0.90c and 0.995c. Comparing the times when some jets go unstable to these initial parameters allow us to find a threshold where radio-loud AGNs transition from class II to class I. With these high resolution fully 3D relativistic simulations we can represent the jets more accurately and thus improve upon and refine earlier results that were based on 2D simulations.

  6. Skeletal maturation of the cervical vertebrae: association with various types of malocclusion.

    PubMed

    Armond, Mônica Costa; Generoso, Rodrigo; Falci, Saulo Gabriel Moreira; Ramos-Jorge, Maria Letícia; Marques, Leandro Silva

    2012-01-01

    The identification of the skeletal maturation stage of the cervical vertebrae has proven an important reference for orthodontic diagnosis. The aim of the present study was to determine the association between the skeletal maturation stage of the cervical vertebrae and types of malocclusion according to the age and gender of participants. A total of 361 individuals (168 males and 193 females) between 8 and 14 years of age were selected from a convenience sample. Malocclusions were diagnosed through study models using the Angle classification. Maturation stages of the cervical vertebrae were determined using the method proposed by Hassel and Farman. Statistical analysis involved the chi-square test (p £ 0.05) and multiple logistic regression (forward stepwise procedure). Significant differences were observed between the stage of skeletal maturation of the cervical vertebrae and gender at ages 11, 12 and 14 years. Males with Class II malocclusion were twice as likely to be in Stage 1 or 2 of cervical vertebra maturation than individuals with Class I malocclusion (OR = 2.1 [CI 95%, 1.33-3.18]). There were no differences between individuals with Class I and Class III malocclusions. The association between skeletal maturation of the cervical vertebrae and type of malocclusion was significant, suggesting a skeletal component in the determination of Class II malocclusions.

  7. Speech Music Discrimination Using Class-Specific Features

    DTIC Science & Technology

    2004-08-01

    Speech Music Discrimination Using Class-Specific Features Thomas Beierholm...between speech and music . Feature extraction is class-specific and can therefore be tailored to each class meaning that segment size, model orders...interest. Some of the applications of audio signal classification are speech/ music classification [1], acoustical environmental classification [2][3

  8. WND-CHARM: Multi-purpose image classification using compound image transforms

    PubMed Central

    Orlov, Nikita; Shamir, Lior; Macura, Tomasz; Johnston, Josiah; Eckley, D. Mark; Goldberg, Ilya G.

    2008-01-01

    We describe a multi-purpose image classifier that can be applied to a wide variety of image classification tasks without modifications or fine-tuning, and yet provide classification accuracy comparable to state-of-the-art task-specific image classifiers. The proposed image classifier first extracts a large set of 1025 image features including polynomial decompositions, high contrast features, pixel statistics, and textures. These features are computed on the raw image, transforms of the image, and transforms of transforms of the image. The feature values are then used to classify test images into a set of pre-defined image classes. This classifier was tested on several different problems including biological image classification and face recognition. Although we cannot make a claim of universality, our experimental results show that this classifier performs as well or better than classifiers developed specifically for these image classification tasks. Our classifier’s high performance on a variety of classification problems is attributed to (i) a large set of features extracted from images; and (ii) an effective feature selection and weighting algorithm sensitive to specific image classification problems. The algorithms are available for free download from openmicroscopy.org. PMID:18958301

  9. Classification of O Stars in the Yellow-Green: The Exciting Star VES 735

    NASA Astrophysics Data System (ADS)

    Kerton, C. R.; Ballantyne, D. R.; Martin, P. G.

    1999-05-01

    Acquiring data for spectral classification of heavily reddened stars using traditional criteria in the blue-violet region of the spectrum can be prohibitively time consuming using small to medium sized telescopes. One such star is the Vatican Observatory emission-line star VES 735, which we have found excites the H II region KR 140. In order to classify VES 735, we have constructed an atlas of stellar spectra of O stars in the yellow-green (4800-5420 Å). We calibrate spectral type versus the line ratio He I lambda4922:He II lambda5411, showing that this ratio should be useful for the classification of heavily reddened O stars associated with H II regions. Application to VES 735 shows that the spectral type is O8.5. The absolute magnitude suggests luminosity class V. Comparison of the rate of emission of ionizing photons and the bolometric luminosity of VES 735, inferred from radio and infrared measurements of the KR 140 region, to recent stellar models gives consistent evidence for a main-sequence star of mass 25 M_solar and age less than a few million years with a covering factor 0.4-0.5 by the nebular material. Spectra taken in the red (6500-6700 Å) show that the stellar Hα emission is double-peaked about the systemic velocity and slightly variable. Hβ is in absorption, so that the emission-line classification is ``(e)''. However, unlike the case of the more well-known O(e) star zeta Oph, the emission from VES 735 appears to be long-lived rather than episodic.

  10. Modular Digital Missile Guidance, Phase I2

    DTIC Science & Technology

    1976-01-28

    at OMR. The revised study plan was fornally approved by ONR on 29 May 1975, confining the sinulatlon analysis work to a Class II missile with...functions analyzed in tne Phase I and Phase 11 studies . It can be seen thatf tnere practicable» (based on the results of function partitioning trade...llaillAU AS a result of this study » three generic missile families have oeen established and» relative to this classification» on

  11. Information, Consistent Estimation and Dynamic System Identification.

    DTIC Science & Technology

    1976-11-01

    Washington,DC 232129 Tj-CUOSITORING AGENCY NAMIE 6 AOORESS(lI dittevmet Itroo CuooottaaII Offics) IS.- SECURITY CLASS. (of this *.part) SCHEDULE ’B...representative model from a given model set, applicable to infinite and even non-compact model sets. S-UNCLASSIFIED SECURITY CLASSIFICATION OF THIS PAOrj(*whe...ergodicity. For a thorough development of ergodic theory the reader is referred to, e.g., Doob [1953], Halmos [1956] and Chacon and Ornstein [1959

  12. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Downes, R.A.

    Galactic plane ultraviolet-excess (uv-excess) objects covering about 1000 square degrees of sky were surveyed. Photographic plates were obtained with both uv and blue filters, to select the uv-excess candidates, which were then observed spectroscopically to determine their classification. Most of the objects selected were nearby early-type stars with low interstellar reddening; however, a collection of hot white dwarfs, subdwarf O (sdO) stars, subdwarf B (sdB) stars, and cataclysmic variables was also found. Photoelectric photometry was obtained for these stars and a statistical analysis was performed to determine the space densities and scale heights for the four classes of objects. Severalmore » interesting objects (or class of objects) were discovered, and data for some of these stars are presented. Among the peculiar objects found are an emission-line white dwarf similar to the pulsating PG 1159 stars, a Population II Wolf-Rayet star, a previously catalogued object with a strong Fe II emission-line spectrum, and a new class of object, resembling the sdB stars, that shows variable strength H..cap alpha.. absorption, with the H..cap alpha.. line sometimes completely filled in.« less

  13. Multi-class biological tissue classification based on a multi-classifier: Preliminary study of an automatic output power control for ultrasonic surgical units.

    PubMed

    Youn, Su Hyun; Sim, Taeyong; Choi, Ahnryul; Song, Jinsung; Shin, Ki Young; Lee, Il Kwon; Heo, Hyun Mu; Lee, Daeweon; Mun, Joung Hwan

    2015-06-01

    Ultrasonic surgical units (USUs) have the advantage of minimizing tissue damage during surgeries that require tissue dissection by reducing problems such as coagulation and unwanted carbonization, but the disadvantage of requiring manual adjustment of power output according to the target tissue. In order to overcome this limitation, it is necessary to determine the properties of in vivo tissues automatically. We propose a multi-classifier that can accurately classify tissues based on the unique impedance of each tissue. For this purpose, a multi-classifier was built based on single classifiers with high classification rates, and the classification accuracy of the proposed model was compared with that of single classifiers for various electrode types (Type-I: 6 mm invasive; Type-II: 3 mm invasive; Type-III: surface). The sensitivity and positive predictive value (PPV) of the multi-classifier by cross checks were determined. According to the 10-fold cross validation results, the classification accuracy of the proposed model was significantly higher (p<0.05 or <0.01) than that of existing single classifiers for all electrode types. In particular, the classification accuracy of the proposed model was highest when the 3mm invasive electrode (Type-II) was used (sensitivity=97.33-100.00%; PPV=96.71-100.00%). The results of this study are an important contribution to achieving automatic optimal output power adjustment of USUs according to the properties of individual tissues. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies†,‡

    PubMed Central

    Grimbizis, Grigoris F.; Gordts, Stephan; Di Spiezio Sardo, Attilio; Brucker, Sara; De Angelis, Carlo; Gergolet, Marco; Li, Tin-Chiu; Tanos, Vasilios; Brölmann, Hans; Gianaroli, Luca; Campo, Rudi

    2013-01-01

    STUDY QUESTION What classification system is more suitable for the accurate, clear, simple and related to the clinical management categorization of female genital anomalies? SUMMARY ANSWER The new ESHRE/ESGE classification system of female genital anomalies is presented. WHAT IS KNOWN ALREADY Congenital malformations of the female genital tract are common miscellaneous deviations from normal anatomy with health and reproductive consequences. Until now, three systems have been proposed for their categorization but all of them are associated with serious limitations. STUDY DESIGN, SIZE AND DURATION The European Society of Human Reproduction and Embryology (ESHRE) and the European Society for Gynaecological Endoscopy (ESGE) have established a common Working Group, under the name CONUTA (CONgenital UTerine Anomalies), with the goal of developing a new updated classification system. A scientific committee (SC) has been appointed to run the project, looking also for consensus within the scientists working in the field. PARTICIPANTS/MATERIALS, SETTING, METHODS The new system is designed and developed based on (i) scientific research through critical review of current proposals and preparation of an initial proposal for discussion between the experts, (ii) consensus measurement among the experts through the use of the DELPHI procedure and (iii) consensus development by the SC, taking into account the results of the DELPHI procedure and the comments of the experts. Almost 90 participants took part in the process of development of the ESHRE/ESGE classification system, contributing with their structured answers and comments. MAIN RESULTS AND THE ROLE OF CHANCE The ESHRE/ESGE classification system is based on anatomy. Anomalies are classified into the following main classes, expressing uterine anatomical deviations deriving from the same embryological origin: U0, normal uterus; U1, dysmorphic uterus; U2, septate uterus; U3, bicorporeal uterus; U4, hemi-uterus; U5, aplastic uterus; U6, for still unclassified cases. Main classes have been divided into sub-classes expressing anatomical varieties with clinical significance. Cervical and vaginal anomalies are classified independently into sub-classes having clinical significance. LIMITATIONS, REASONS FOR CAUTION The ESHRE/ESGE classification of female genital anomalies seems to fulfill the expectations and the needs of the experts in the field, but its clinical value needs to be proved in everyday practice. WIDER IMPLICATIONS OF THE FINDINGS The ESHRE/ESGE classification system of female genital anomalies could be used as a starting point for the development of guidelines for their diagnosis and treatment. STUDY FUNDING/COMPETING INTEREST(S) None. PMID:23771171

  15. Excavatability and the effect of weathering degree on the excavatability of rock masses: An example from Eastern Turkey

    NASA Astrophysics Data System (ADS)

    Gurocak, Zulfu; Yalcin, Erkut

    2016-06-01

    In this study, the effect of the weathering degree on the excavatability of rock masses was investigated. The ophiolitic rock mass along the route of Komurhan Tunnel was chosen as the case study. Both laboratory and field studies were carried out for this purpose. In the first stage, the ophiolitic rock mass along the tunnel route was classified into three subzones according to the weathering degree and the ophiolitic rock masses of the each subzones were classified using the empirical excavatability classifications proposed by the different researchers. Furthermore, in-situ excavatability classes of rock masses in each zone were determined and the results were compared. The in-situ excavatability class of fresh (Zone-I) and slightly weathered (Zone-II) rock masses was determined as Blasting and that of moderately weathered (Zone-III) rock mass was determined as Very Hard/Very Difficult. As the obtained results were compared, it was found that the weathering degree has a significant effect on the excavatability and that it is more appropriate to prefer empirical classifications in the empirical determination of excavatability classes of rock masses having the same lithology by taking the weathering degree into account.

  16. Resource theory of non-Gaussian operations

    NASA Astrophysics Data System (ADS)

    Zhuang, Quntao; Shor, Peter W.; Shapiro, Jeffrey H.

    2018-05-01

    Non-Gaussian states and operations are crucial for various continuous-variable quantum information processing tasks. To quantitatively understand non-Gaussianity beyond states, we establish a resource theory for non-Gaussian operations. In our framework, we consider Gaussian operations as free operations, and non-Gaussian operations as resources. We define entanglement-assisted non-Gaussianity generating power and show that it is a monotone that is nonincreasing under the set of free superoperations, i.e., concatenation and tensoring with Gaussian channels. For conditional unitary maps, this monotone can be analytically calculated. As examples, we show that the non-Gaussianity of ideal photon-number subtraction and photon-number addition equal the non-Gaussianity of the single-photon Fock state. Based on our non-Gaussianity monotone, we divide non-Gaussian operations into two classes: (i) the finite non-Gaussianity class, e.g., photon-number subtraction, photon-number addition, and all Gaussian-dilatable non-Gaussian channels; and (ii) the diverging non-Gaussianity class, e.g., the binary phase-shift channel and the Kerr nonlinearity. This classification also implies that not all non-Gaussian channels are exactly Gaussian dilatable. Our resource theory enables a quantitative characterization and a first classification of non-Gaussian operations, paving the way towards the full understanding of non-Gaussianity.

  17. Differentiation of Candida albicans, Candida glabrata, and Candida krusei by FT-IR and chemometrics by CHROMagar™ Candida.

    PubMed

    Wohlmeister, Denise; Vianna, Débora Renz Barreto; Helfer, Virginia Etges; Calil, Luciane Noal; Buffon, Andréia; Fuentefria, Alexandre Meneghello; Corbellini, Valeriano Antonio; Pilger, Diogo André

    2017-10-01

    Pathogenic Candida species are detected in clinical infections. CHROMagar™ is a phenotypical method used to identify Candida species, although it has limitations, which indicates the need for more sensitive and specific techniques. Infrared Spectroscopy (FT-IR) is an analytical vibrational technique used to identify patterns of metabolic fingerprint of biological matrixes, particularly whole microbial cell systems as Candida sp. in association of classificatory chemometrics algorithms. On the other hand, Soft Independent Modeling by Class Analogy (SIMCA) is one of the typical algorithms still little employed in microbiological classification. This study demonstrates the applicability of the FT-IR-technique by specular reflectance associated with SIMCA to discriminate Candida species isolated from vaginal discharges and grown on CHROMagar™. The differences in spectra of C. albicans, C. glabrata and C. krusei were suitable for use in the discrimination of these species, which was observed by PCA. Then, a SIMCA model was constructed with standard samples of three species and using the spectral region of 1792-1561cm -1 . All samples (n=48) were properly classified based on the chromogenic method using CHROMagar™ Candida. In total, 93.4% (n=45) of the samples were correctly and unambiguously classified (Class I). Two samples of C. albicans were classified correctly, though these could have been C. glabrata (Class II). Also, one C. glabrata sample could have been classified as C. krusei (Class II). Concerning these three samples, one triplicate of each was included in Class II and two in Class I. Therefore, FT-IR associated with SIMCA can be used to identify samples of C. albicans, C. glabrata, and C. krusei grown in CHROMagar™ Candida aiming to improve clinical applications of this technique. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Systemic treatment after whole-brain radiotherapy may improve survival in RPA class II/III breast cancer patients with brain metastasis.

    PubMed

    Zhang, Qian; Chen, Jian; Yu, Xiaoli; Ma, Jinli; Cai, Gang; Yang, Zhaozhi; Cao, Lu; Chen, Xingxing; Guo, Xiaomao; Chen, Jiayi

    2013-09-01

    Whole brain radiotherapy (WBRT) is the most widely used treatment for brain metastasis (BM), especially for patients with multiple intracranial lesions. The purpose of this study was to examine the efficacy of systemic treatments following WBRT in breast cancer patients with BM who had different clinical characteristics, based on the classification of the Radiation Therapy Oncology Group recursive partitioning analysis (RPA) and the breast cancer-specific Graded Prognostic Assessment (Breast-GPA). One hundred and one breast cancer patients with BM treated between 2006 and 2010 were analyzed. The median interval between breast cancer diagnosis and identification of BM in the triple-negative patients was shorter than in the luminal A subtype (26 vs. 36 months, respectively; P = 0.021). Univariate analysis indicated that age at BM diagnosis, Karnofsky performance status/recursive partitioning analysis (KPS/RPA) classes, number of BMs, primary tumor control, extracranial metastases and systemic treatment following WBRT were significant prognostic factors for overall survival (OS) (P < 0.05). Multivariate analysis revealed that KPS/RPA classes and systemic treatments following WBRT remained the significant prognostic factors for OS. For RPA class I, the median survival with and without systemic treatments following WBRT was 25 and 22 months, respectively (P = 0.819), while for RPA class II/III systemic treatments significantly improved OS from 7 and 2 months to 11 and 5 months, respectively (P < 0.05). Our results suggested that triple-negative patients had a shorter interval between initial diagnosis and the development of BM than luminal A patients. Systemic treatments following WBRT improved the survival of RPA class II/III patients.

  19. Association between third molar and mandibular angle fracture: A systematic review and meta-analysis.

    PubMed

    Giovacchini, Francesco; Paradiso, Daniele; Bensi, Caterina; Belli, Stefano; Lomurno, Giuseppe; Tullio, Antonio

    2018-04-01

    The aim of this study was to investigate the risk of mandibular angle fracture associated with the presence of a mandibular third molar and its position when the mandibular fracture occurs. A systematic literary search was performed in Pubmed, Scopus, and the Cochrane Library for observational studies with at least 250 patients that included frequency of mandibular angle fracture, presence of third molar, and its position. A total of seven studies were included in the review, from an initial search of 622 titles. The relative risk of mandibular angle fracture with third molar was 1.90 (95% CI = 1.47-2.46). The relative risk of mandibular angle fracture related to third molar position (according to the Pell and Gregory classification) was 1.18 (95% CI = 0.62-2.25), 1.98 (95% CI = 0.95-4.10), 2.72 (95% CI = 1.78-4.16), 1.31 (95% CI = 0.80-2.14), 2.21 (95% CI = 1.69-2.87) and 2.99 (95% CI = 2.12-4.22) for Class A, Class B, Class C, Class I, Class II, and Class III, respectively. Our meta-analysis reported a two-fold increased risk of mandibular angle fracture with the presence of a third molar in patients who presented with mandibular fractures. Even the third molar position seemed to influence mandibular angle fracture, especially Class C, Class II, and Class III. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  20. Object-based classification of global undersea topography and geomorphological features from the SRTM30_PLUS data

    NASA Astrophysics Data System (ADS)

    Dekavalla, Maria; Argialas, Demetre

    2017-07-01

    The analysis of undersea topography and geomorphological features provides necessary information to related disciplines and many applications. The development of an automated knowledge-based classification approach of undersea topography and geomorphological features is challenging due to their multi-scale nature. The aim of the study is to develop and evaluate an automated knowledge-based OBIA approach to: i) decompose the global undersea topography to multi-scale regions of distinct morphometric properties, and ii) assign the derived regions to characteristic geomorphological features. First, the global undersea topography was decomposed through the SRTM30_PLUS bathymetry data to the so-called morphometric objects of discrete morphometric properties and spatial scales defined by data-driven methods (local variance graphs and nested means) and multi-scale analysis. The derived morphometric objects were combined with additional relative topographic position information computed with a self-adaptive pattern recognition method (geomorphons), and auxiliary data and were assigned to characteristic undersea geomorphological feature classes through a knowledge base, developed from standard definitions. The decomposition of the SRTM30_PLUS data to morphometric objects was considered successful for the requirements of maximizing intra-object and inter-object heterogeneity, based on the near zero values of the Moran's I and the low values of the weighted variance index. The knowledge-based classification approach was tested for its transferability in six case studies of various tectonic settings and achieved the efficient extraction of 11 undersea geomorphological feature classes. The classification results for the six case studies were compared with the digital global seafloor geomorphic features map (GSFM). The 11 undersea feature classes and their producer's accuracies in respect to the GSFM relevant areas were Basin (95%), Continental Shelf (94.9%), Trough (88.4%), Plateau (78.9%), Continental Slope (76.4%), Trench (71.2%), Abyssal Hill (62.9%), Abyssal Plain (62.4%), Ridge (49.8%), Seamount (48.8%) and Continental Rise (25.4%). The knowledge-based OBIA classification approach was considered transferable since the percentages of spatial and thematic agreement between the most of the classified undersea feature classes and the GSFM exhibited low deviations across the six case studies.

  1. Validity of the American Board of Orthodontics Discrepancy Index and the Peer Assessment Rating Index for comprehensive evaluation of malocclusion severity.

    PubMed

    Liu, S; Oh, H; Chambers, D W; Baumrind, S; Xu, T

    2017-08-01

    To assess the validity of the American Board of Orthodontics Discrepancy Index (ABO-DI) and Peer Assessment Rating (PAR) Index in evaluating malocclusion severity in Chinese orthodontic patients. A stratified random sample of 120 orthodontic patients based on Angle classification was collected from six university orthodontic centres. Sixty-nine orthodontists rated malocclusion severity on a five-point scale by assessing a full set of pre-treatment records for each case and listed reasons for their decision. Their judgement was then compared with ABO-DI and PAR scores determined by three calibrated examiners. Excellent interexaminer reliability of clinician judgement, ABO-DI and PAR index was demonstrated by the Intraclass Correlation Coefficient (rho= 0.995, 0.990 and 0.964, respectively). Both the ABO-DI and US-PAR index showed good correlation with clinician judgement (r=.700 and r=.707, respectively). There was variability among the different Angle classifications: the ABO-DI showed the highest correlation with clinician judgement in Class II patients (r=.780), whereas the US-PAR index showed the highest correlation with clinician judgement in Class III patients (r=.710). Both indices demonstrated the lowest correlations with clinician judgement in Class I patients. With strong interexaminer agreement, the panel consensus was used for validating the ABO-DI and US-PAR index for malocclusion severity. Overall, the ABO-DI and US-PAR index were reliable for measuring malocclusion severity with significantly variable weightings for different Angle classifications. Further modification of the indices for different Angle classification may be indicated. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. EXhype: A tool for mineral classification using hyperspectral data

    NASA Astrophysics Data System (ADS)

    Adep, Ramesh Nityanand; shetty, Amba; Ramesh, H.

    2017-02-01

    Various supervised classification algorithms have been developed to classify earth surface features using hyperspectral data. Each algorithm is modelled based on different human expertises. However, the performance of conventional algorithms is not satisfactory to map especially the minerals in view of their typical spectral responses. This study introduces a new expert system named 'EXhype (Expert system for hyperspectral data classification)' to map minerals. The system incorporates human expertise at several stages of it's implementation: (i) to deal with intra-class variation; (ii) to identify absorption features; (iii) to discriminate spectra by considering absorption features, non-absorption features and by full spectra comparison; and (iv) finally takes a decision based on learning and by emphasizing most important features. It is developed using a knowledge base consisting of an Optimal Spectral Library, Segmented Upper Hull method, Spectral Angle Mapper (SAM) and Artificial Neural Network. The performance of the EXhype is compared with a traditional, most commonly used SAM algorithm using Airborne Visible/Infrared Imaging Spectrometer (AVIRIS) data acquired over Cuprite, Nevada, USA. A virtual verification method is used to collect samples information for accuracy assessment. Further, a modified accuracy assessment method is used to get a real users accuracies in cases where only limited or desired classes are considered for classification. With the modified accuracy assessment method, SAM and EXhype yields an overall accuracy of 60.35% and 90.75% and the kappa coefficient of 0.51 and 0.89 respectively. It was also found that the virtual verification method allows to use most desired stratified random sampling method and eliminates all the difficulties associated with it. The experimental results show that EXhype is not only producing better accuracy compared to traditional SAM but, can also rightly classify the minerals. It is proficient in avoiding misclassification between target classes when applied on minerals.

  3. Influencing factors of NT-proBNP level inheart failure patients with different cardiacfunctions and correlation with prognosis.

    PubMed

    Xu, Liang; Chen, Yanchun; Ji, Yanni; Yang, Song

    2018-06-01

    Factors influencing N-terminal pro-brain natriuretic peptide (NT-proBNP) level in heart failure patients with different cardiac functions were identified to explore the correlations with prognosis. Eighty heart failure patients with different cardiac functions treated in Yixing People's Hospital from January 2016 to June 2017 were selected, and divided into two groups (group with cardiac function in class II and below and group with cardiac function in class III and above), according to the cardiac function classification established by New York Heart Association (NYHA). Blood biochemical test and outcome analysis were conducted to measure serum NT-proBNP and matrix metalloproteinase-9 (MMP-9) levels in patients with different cardiac functions, and correlations between levels of NT-proBNP and MMP-9 and left ventricular ejection fraction (LVEF) level were analyzed in patients with different cardiac functions at the same time. In addition, risk factors for heart failure in patients with different cardiac functions were analyzed. Compared with the group with cardiac function in class III and above, the group with cardiac function in class II and below had significantly lower serum NT-proBNP and MMP-9 levels (p<0.05). For echocardiogram indexes, left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) in the group with cardiac function in class II and below were obviously lower than those in the group with cardiac function in class III and above (p<0.05), while LVEF was higher in group with cardiac function in class II and below than that in group with cardiac function in class III and above (p<0.05). NT-proBNP and MMP-9 levels were negatively correlated with LVEF level [r=-0.8517 and -0.8517, respectively, p<0.001 (<0.05)]. Cardiac function in class III and above, increased NT-proBNP, increased MMP-9 and decreased LVEF were relevant risk factors and independent risk factors for heart failure in patients with different cardiac functions. NT-proBNP and MMP-9 levels are negatively correlated with LVEF in patients regardless of the cardiac function class. Therefore, attention should be paid to patients who have cardiac function in class III and above, increased NT-proBNP and MMP-9 levels and decreased LVEF in clinical practices, so as to actively prevent and treat heart failure.

  4. [Proposals for social class classification based on the Spanish National Classification of Occupations 2011 using neo-Weberian and neo-Marxist approaches].

    PubMed

    Domingo-Salvany, Antònia; Bacigalupe, Amaia; Carrasco, José Miguel; Espelt, Albert; Ferrando, Josep; Borrell, Carme

    2013-01-01

    In Spain, the new National Classification of Occupations (Clasificación Nacional de Ocupaciones [CNO-2011]) is substantially different to the 1994 edition, and requires adaptation of occupational social classes for use in studies of health inequalities. This article presents two proposals to measure social class: the new classification of occupational social class (CSO-SEE12), based on the CNO-2011 and a neo-Weberian perspective, and a social class classification based on a neo-Marxist approach. The CSO-SEE12 is the result of a detailed review of the CNO-2011 codes. In contrast, the neo-Marxist classification is derived from variables related to capital and organizational and skill assets. The proposed CSO-SEE12 consists of seven classes that can be grouped into a smaller number of categories according to study needs. The neo-Marxist classification consists of 12 categories in which home owners are divided into three categories based on capital goods and employed persons are grouped into nine categories composed of organizational and skill assets. These proposals are complemented by a proposed classification of educational level that integrates the various curricula in Spain and provides correspondences with the International Standard Classification of Education. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

  5. A Biochar Classification System and Associated Test Methods

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Camps-Arbestain, Marta; Amonette, James E.; Singh, Balwant

    2015-02-18

    In this chapter, a biochar classification system related to its use as soil amendment is proposed. This document builds upon previous work and constrains its scope to materials with properties that satisfy the criteria for biochar as defined by either the International Biochar Initiative (IBI) Biochar Standards or the European Biochar Community (EBC) Standards, and it is intended to minimise the need for testing in addition to those required according to the above-mentioned standards. The classification system envisions enabling stakeholders and commercial entities to (i) identify the most suitable biochar to fulfil the requirements for a particular soil and/or land-use,more » and (ii) distinguish the application of biochar for specific niches (e.g., soilless agriculture). It is based on the best current knowledge and the intention is to periodically review and update the document based on new data and knowledge that become available in the scientific literature. The main thrust of this classification system is based on the direct or indirect beneficial effects that biochar provides from its application to soil. We have classified the potential beneficial effects of biochar application to soils into five categories with their corresponding classes, where applicable: (i) carbon (C) storage value, (ii) fertiliser value, (iii) liming value, (iv) particle-size, and (v) use in soil-less agriculture. A summary of recommended test methods is provided at the end of the chapter.« less

  6. ACTN3 R577X Genotypes Associate with Class II and Deep Bite Malocclusions

    PubMed Central

    Zebrick, Brian; Teeramongkolgul, Teesit; Nicot, Romain; Horton, Michael J.; Raoul, Gwenael; Ferri, Joel; Vieira, Alexandre R.; Sciote, James J.

    2014-01-01

    Introduction α-actinins are myofibril anchor proteins which influence contractile properties of skeletal muscle. ACTN2 is expressed in slow type I and fast type II fibers whereas ACTN3 is expressed only in fast fibers. ACTN3 homozygosity for the 577X stop codon (i.e. changing 577RR to 577XX - the R577X polymorphism) results in the absence of α-actinin-3 in about 18% of Europeans, diminished fast contractile ability, enhanced endurance performance and reduced bone mass or bone mineral density. We have examined ACTN3 expression and genetic variation in masseter muscle of orthognathic surgery patients to determine genotype associations with malocclusion. Methods Clinical information, masseter muscle biopsies and saliva samples were obtained from 60 subjects. Genotyping for ACTN3 SNPs, RT-PCR quantitation of muscle gene message and muscle morphometric fiber type properties were compared to determine statistical differences between genotype and phenotype. Results Muscle mRNA expression level was significantly different for ACTN3 SNP genotypes (p<0.01). The frequency of ACTN3 genotypes was significantly different for sagittal and vertical classifications of malocclusion with the clearest association being elevated 577XX genotype in skeletal class II malocclusion (p = 0.003). This genotype also resulted in significantly smaller diameter of fast type II fibers in masseter muscle (p = 0.002). Conclusion ACTN3 577XX is overrepresented in skeletal class II malocclusion, suggesting a biologic influence during bone growth. ACTN3 577XX is underrepresented in deep bite malocclusion, suggesting muscle differences contribute to variations in vertical facial dimensions. PMID:25439211

  7. Classification of stellar spectra with SVM based on within-class scatter and between-class scatter

    NASA Astrophysics Data System (ADS)

    Liu, Zhong-bao; Zhou, Fang-xiao; Qin, Zhen-tao; Luo, Xue-gang; Zhang, Jing

    2018-07-01

    Support Vector Machine (SVM) is a popular data mining technique, and it has been widely applied in astronomical tasks, especially in stellar spectra classification. Since SVM doesn't take the data distribution into consideration, and therefore, its classification efficiencies can't be greatly improved. Meanwhile, SVM ignores the internal information of the training dataset, such as the within-class structure and between-class structure. In view of this, we propose a new classification algorithm-SVM based on Within-Class Scatter and Between-Class Scatter (WBS-SVM) in this paper. WBS-SVM tries to find an optimal hyperplane to separate two classes. The difference is that it incorporates minimum within-class scatter and maximum between-class scatter in Linear Discriminant Analysis (LDA) into SVM. These two scatters represent the distributions of the training dataset, and the optimization of WBS-SVM ensures the samples in the same class are as close as possible and the samples in different classes are as far as possible. Experiments on the K-, F-, G-type stellar spectra from Sloan Digital Sky Survey (SDSS), Data Release 8 show that our proposed WBS-SVM can greatly improve the classification accuracies.

  8. Design of partially supervised classifiers for multispectral image data

    NASA Technical Reports Server (NTRS)

    Jeon, Byeungwoo; Landgrebe, David

    1993-01-01

    A partially supervised classification problem is addressed, especially when the class definition and corresponding training samples are provided a priori only for just one particular class. In practical applications of pattern classification techniques, a frequently observed characteristic is the heavy, often nearly impossible requirements on representative prior statistical class characteristics of all classes in a given data set. Considering the effort in both time and man-power required to have a well-defined, exhaustive list of classes with a corresponding representative set of training samples, this 'partially' supervised capability would be very desirable, assuming adequate classifier performance can be obtained. Two different classification algorithms are developed to achieve simplicity in classifier design by reducing the requirement of prior statistical information without sacrificing significant classifying capability. The first one is based on optimal significance testing, where the optimal acceptance probability is estimated directly from the data set. In the second approach, the partially supervised classification is considered as a problem of unsupervised clustering with initially one known cluster or class. A weighted unsupervised clustering procedure is developed to automatically define other classes and estimate their class statistics. The operational simplicity thus realized should make these partially supervised classification schemes very viable tools in pattern classification.

  9. Identification of transitional disks in Chamaeleon with Herschel

    NASA Astrophysics Data System (ADS)

    Ribas, Á.; Merín, B.; Bouy, H.; Alves de Oliveira, C.; Ardila, D. R.; Puga, E.; Kóspál, Á.; Spezzi, L.; Cox, N. L. J.; Prusti, T.; Pilbratt, G. L.; André, Ph.; Matrà, L.; Vavrek, R.

    2013-04-01

    Context. Transitional disks are circumstellar disks with inner holes that in some cases are produced by planets and/or substellar companions in these systems. For this reason, these disks are extremely important for the study of planetary system formation. Aims: The Herschel Space Observatory provides an unique opportunity for studying the outer regions of protoplanetary disks. In this work we update previous knowledge on the transitional disks in the Chamaeleon I and II regions with data from the Herschel Gould Belt Survey. Methods: We propose a new method for transitional disk classification based on the WISE 12 μm - PACS 70 μm color, together with inspection of the Herschel images. We applied this method to the population of Class II sources in the Chamaeleon region and studied the spectral energy distributions of the transitional disks in the sample. We also built the median spectral energy distribution of Class II objects in these regions for comparison with transitional disks. Results: The proposed method allows a clear separation of the known transitional disks from the Class II sources. We find six transitional disks, all previously known, and identify five objects previously thought to be transitional as possibly non-transitional. We find higher fluxes at the PACS wavelengths in the sample of transitional disks than those of Class II objects. Conclusions: We show the Herschel 70 μm band to be a robust and efficient tool for transitional disk identification. The sensitivity and spatial resolution of Herschel reveals a significant contamination level among the previously identified transitional disk candidates for the two regions, which calls for a revision of previous samples of transitional disks in other regions. The systematic excess found at the PACS bands could be either a result of the mechanism that produces the transitional phase, or an indication of different evolutionary paths for transitional disks and Class II sources. Herschel is an ESA space observatory with science instruments provided by European-led Principal Investigator consortia and with important participation from NASA.Appendix A is available in electronic form at http://www.aanda.org

  10. Automatic classification of spectra from the Infrared Astronomical Satellite (IRAS)

    NASA Technical Reports Server (NTRS)

    Cheeseman, Peter; Stutz, John; Self, Matthew; Taylor, William; Goebel, John; Volk, Kevin; Walker, Helen

    1989-01-01

    A new classification of Infrared spectra collected by the Infrared Astronomical Satellite (IRAS) is presented. The spectral classes were discovered automatically by a program called Auto Class 2. This program is a method for discovering (inducing) classes from a data base, utilizing a Bayesian probability approach. These classes can be used to give insight into the patterns that occur in the particular domain, in this case, infrared astronomical spectroscopy. The classified spectra are the entire Low Resolution Spectra (LRS) Atlas of 5,425 sources. There are seventy-seven classes in this classification and these in turn were meta-classified to produce nine meta-classes. The classification is presented as spectral plots, IRAS color-color plots, galactic distribution plots and class commentaries. Cross-reference tables, listing the sources by IRAS name and by Auto Class class, are also given. These classes show some of the well known classes, such as the black-body class, and silicate emission classes, but many other classes were unsuspected, while others show important subtle differences within the well known classes.

  11. Distributed Network Protocols

    DTIC Science & Technology

    1980-07-01

    MONITORING AGENCY NAME & ADDRESS(II different from Controlting Office) IS. SECURITY CLASS. (of this report) S Office of Naval Research Unclassified...All protocols are extended to networks with changing. topology. S80 8 4 246 DD0I iA 1473 EDITION OF INOV 65 IS OBSOLETE 8 0 24 SECURITY CLASSIFICATION...to the netowrk . f) Each node knows its adjacent links, but not necessarily the identity of its neighbors, i.e. the nodes at the other end of the links

  12. Mapping ecological states in a complex environment

    NASA Astrophysics Data System (ADS)

    Steele, C. M.; Bestelmeyer, B.; Burkett, L. M.; Ayers, E.; Romig, K.; Slaughter, A.

    2013-12-01

    The vegetation of northern Chihuahuan Desert rangelands is sparse, heterogeneous and for most of the year, consists of a large proportion of non-photosynthetic material. The soils in this area are spectrally bright and variable in their reflectance properties. Both factors provide challenges to the application of remote sensing for estimating canopy variables (e.g., leaf area index, biomass, percentage canopy cover, primary production). Additionally, with reference to current paradigms of rangeland health assessment, remotely-sensed estimates of canopy variables have limited practical use to the rangeland manager if they are not placed in the context of ecological site and ecological state. To address these challenges, we created a multifactor classification system based on the USDA-NRCS ecological site schema and associated state-and-transition models to map ecological states on desert rangelands in southern New Mexico. Applying this system using per-pixel image processing techniques and multispectral, remotely sensed imagery raised other challenges. Per-pixel image classification relies upon the spectral information in each pixel alone, there is no reference to the spatial context of the pixel and its relationship with its neighbors. Ecological state classes may have direct relevance to managers but the non-unique spectral properties of different ecological state classes in our study area means that per-pixel classification of multispectral data performs poorly in discriminating between different ecological states. We found that image interpreters who are familiar with the landscape and its associated ecological site descriptions perform better than per-pixel classification techniques in assigning ecological states. However, two important issues affect manual classification methods: subjectivity of interpretation and reproducibility of results. An alternative to per-pixel classification and manual interpretation is object-based image analysis. Object-based image analysis provides a platform for classification that more closely resembles human recognition of objects within a remotely sensed image. The analysis presented here compares multiple thematic maps created for test locations on the USDA-ARS Jornada Experimental Range ranch. Three study sites in different pastures, each 300 ha in size, were selected for comparison on the basis of their ecological site type (';Clayey', ';Sandy' and a combination of both) and the degree of complexity of vegetation cover. Thematic maps were produced for each study site using (i) manual interpretation of digital aerial photography (by five independent interpreters); (ii) object-oriented, decision-tree classification of fine and moderate spatial resolution imagery (Quickbird; Landsat Thematic Mapper) and (iii) ground survey. To identify areas of uncertainty, we compared agreement in location, areal extent and class assignation between 5 independently produced, manually-digitized ecological state maps and with the map created from ground survey. Location, areal extent and class assignation of the map produced by object-oriented classification was also assessed with reference to the ground survey map.

  13. Feature Selection Has a Large Impact on One-Class Classification Accuracy for MicroRNAs in Plants.

    PubMed

    Yousef, Malik; Saçar Demirci, Müşerref Duygu; Khalifa, Waleed; Allmer, Jens

    2016-01-01

    MicroRNAs (miRNAs) are short RNA sequences involved in posttranscriptional gene regulation. Their experimental analysis is complicated and, therefore, needs to be supplemented with computational miRNA detection. Currently computational miRNA detection is mainly performed using machine learning and in particular two-class classification. For machine learning, the miRNAs need to be parametrized and more than 700 features have been described. Positive training examples for machine learning are readily available, but negative data is hard to come by. Therefore, it seems prerogative to use one-class classification instead of two-class classification. Previously, we were able to almost reach two-class classification accuracy using one-class classifiers. In this work, we employ feature selection procedures in conjunction with one-class classification and show that there is up to 36% difference in accuracy among these feature selection methods. The best feature set allowed the training of a one-class classifier which achieved an average accuracy of ~95.6% thereby outperforming previous two-class-based plant miRNA detection approaches by about 0.5%. We believe that this can be improved upon in the future by rigorous filtering of the positive training examples and by improving current feature clustering algorithms to better target pre-miRNA feature selection.

  14. Fast-HPLC Fingerprinting to Discriminate Olive Oil from Other Edible Vegetable Oils by Multivariate Classification Methods.

    PubMed

    Jiménez-Carvelo, Ana M; González-Casado, Antonio; Pérez-Castaño, Estefanía; Cuadros-Rodríguez, Luis

    2017-03-01

    A new analytical method for the differentiation of olive oil from other vegetable oils using reversed-phase LC and applying chemometric techniques was developed. A 3 cm short column was used to obtain the chromatographic fingerprint of the methyl-transesterified fraction of each vegetable oil. The chromatographic analysis took only 4 min. The multivariate classification methods used were k-nearest neighbors, partial least-squares (PLS) discriminant analysis, one-class PLS, support vector machine classification, and soft independent modeling of class analogies. The discrimination of olive oil from other vegetable edible oils was evaluated by several classification quality metrics. Several strategies for the classification of the olive oil were used: one input-class, two input-class, and pseudo two input-class.

  15. Changes in classification of genetic variants in BRCA1 and BRCA2.

    PubMed

    Kast, Karin; Wimberger, Pauline; Arnold, Norbert

    2018-02-01

    Classification of variants of unknown significance (VUS) in the breast cancer genes BRCA1 and BRCA2 changes with accumulating evidence for clinical relevance. In most cases down-staging towards neutral variants without clinical significance is possible. We searched the database of the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC) for changes in classification of genetic variants as an update to our earlier publication on genetic variants in the Centre of Dresden. Changes between 2015 and 2017 were recorded. In the group of variants of unclassified significance (VUS, Class 3, uncertain), only changes of classification towards neutral genetic variants were noted. In BRCA1, 25% of the Class 3 variants (n = 2/8) changed to Class 2 (likely benign) and Class 1 (benign). In BRCA2, in 50% of the Class 3 variants (n = 16/32), a change to Class 2 (n = 10/16) or Class 1 (n = 6/16) was observed. No change in classification was noted in Class 4 (likely pathogenic) and Class 5 (pathogenic) genetic variants in both genes. No up-staging from Class 1, Class 2 or Class 3 to more clinical significance was observed. All variants with a change in classification in our cohort were down-staged towards no clinical significance by a panel of experts of the German Consortium for Hereditary Breast and Ovarian Cancer (GC-HBOC). Prevention in families with Class 3 variants should be based on pedigree based risks and should not be guided by the presence of a VUS.

  16. The Onfp Class in the Magellanic Clouds

    NASA Astrophysics Data System (ADS)

    Walborn, Nolan R.; Howarth, Ian D.; Evans, Christopher J.; Crowther, Paul A.; Moffat, Anthony F. J.; St-Louis, Nicole; Fariña, Cecilia; Bosch, Guillermo L.; Morrell, Nidia I.; Barbá, Rodolfo H.; van Loon, Jacco Th.

    2010-03-01

    The Onfp class of rotationally broadened, hot spectra was defined some time ago in the Galaxy, where its membership to date numbers only eight. The principal defining characteristic is a broad, centrally reversed He II λ 4686 emission profile; other emission and absorption lines are also rotationally broadened. Recent surveys in the Magellanic Clouds (MCs) have brought the class membership there, including some related spectra, to 28. We present a survey of the spectral morphology and rotational velocities, as a first step toward elucidating the nature of this class. Evolved, rapidly rotating hot stars are not expected theoretically, because the stellar winds should brake the rotation. Luminosity classification of these spectra is not possible, because the principal criterion (He II λ4686) is peculiar; however, the MCs provide reliable absolute magnitudes, which show that they span the entire range from dwarfs to supergiants. The Onfp line-broadening distribution is distinct and shifted toward larger values from those of normal O dwarfs and supergiants with >99.99% confidence. All cases with multiple observations show line-profile variations, which even remove some objects from the class temporarily. Some of them are spectroscopic binaries; it is possible that the peculiar profiles may have multiple causes among different objects. The origin and future of these stars are intriguing; for instance, they could be stellar mergers and/or gamma-ray-burst progenitors.

  17. Effect of cyclodextrin complexation on the aqueous solubility and solubility/dose ratio of praziquantel.

    PubMed

    Maragos, Stratos; Archontaki, Helen; Macheras, Panos; Valsami, Georgia

    2009-01-01

    Praziquantel (PZQ), the primary drug of choice in the treatment of schistosomiasis, is a highly lipophilic drug that possesses high permeability and low aqueous solubility and is, therefore, classified as a Class II drug according to the Biopharmaceutics Classification System (BCS). In this work, beta-cyclodextrin (beta-CD) and hydroxypropyl-beta-cyclodextrin (HP-beta-CD) were used in order to determine whether increasing the aqueous solubility of a drug by complexation with CDs, a BCS-Class II compound like PZQ could behave as BCS-Class I (highly soluble/highly permeable) drug. Phase solubility and the kneading and lyophilization techniques were used for inclusion complex preparation; solubility was determined by UV spectroscopy. The ability of the water soluble polymer polyvinylpyrolidone (PVP) to increase the complexation and solubilization efficiency of beta-CD and HP-beta-CD for PZQ was examined. Results showed significant improvement of PZQ solubility in the presence of both cyclodextrins but no additional effect in the presence of PVP. The solubility/dose ratios values of PZQ-cyclodextrin complexes calculated considering the low (150 mg) and the high dose (600 mg) of PZQ, used in practice, indicate that PZQ complexation with CDs may result in drug dosage forms that would behave as a BCS-Class I depending on the administered dose.

  18. Comparison of arch forms between Egyptian and North American white populations.

    PubMed

    Bayome, Mohamed; Sameshima, Glenn T; Kim, Yoonji; Nojima, Kunihiko; Baek, Seung-Hak; Kook, Yoon-Ah

    2011-03-01

    The aim of this study was to evaluate the morphologic differences in the mandibular arches of Egyptian and North American white subjects. The sample included 94 Egyptian subjects (35 Class I, 32 Class II, and 27 Class III) and 92 white subjects (37 Class I, 29 Class II, and 26 Class III). The subjects were grouped according to arch form types (tapered, ovoid, and square) to compare their frequency distribution between ethnic groups in each Angle classification. The most facial portions of 13 proximal contact areas were digitized on scanned images of mandibular casts to estimate the corresponding clinical bracket point for each tooth. Four linear and 2 proportional measurements were taken. In comparing arch dimensions, intermolar width was narrower in Egyptians than in the whites (P = 0.001). There was an even frequency distribution of the 3 arch forms in the Egyptian group. On the other hand, the most frequent arch form was ovoid followed by tapered and square in the white group; the square arch form was significantly less frequent than the tapered and ovoid arch forms (P = 0.029). The arch forms of Egyptians are narrower than those of whites. The distribution of the arch form types in Egyptians showed similar frequency, but the square arch form was less frequent in whites. It is recommended to select narrower archwires from the available variations to suit many Egyptian patients. Copyright © 2011 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  19. Relationship between ionospheric F2-layer critical frequency, F10.7, and F10.7P around African EIA trough

    NASA Astrophysics Data System (ADS)

    Ikubanni, S. O.; Adeniyi, J. O.

    2017-02-01

    Improved ionospheric modeling requires a better understanding of the relationship between ionospheric parameters and their influencing solar and geomagnetic sources. Published reports of the validation of the International Reference Ionosphere (IRI) for quiet-time revealed either underestimation or overestimation at a greater magnitude during high solar fluxes, especially at low latitude. With daily foF2 data from Ouagadougou (geor. 12.4°N, 1.5°W) covering a solar cycle, we have presented preliminary results from the analysis of solar dependence of six different classifications of the data: (i) daily values, (ii) monthly mean, (iii) daily quiet values (with Ap ⩽ 20), (iv) monthly-quiet-mean values, (v) monthly median, and (vi) monthly-quiet-median values. All six classifications show good nonlinear relationship with both F10.7 and F10.7P, however, the differences between the dependence of classes (i) and (iii) of foF2 on the two solar indices is more substantial than those of classes (ii), (iv), (v), and (vi). Of all the six classes, the monthly averages are best related to both solar activity indices. Further analysis shows that magnetic disturbances are non-influential in the variations of the monthly mean of both solar activity indices; this makes both good indices for quiet-time modeling. Likewise, F10.7 and F10.7P are indistinguishable for long-term modeling around the African EIA trough region. While monthly median values may be best for mid-latitude region, either the mean/median values could be used for low-latitude region. However, it could be worthwhile to examine the distribution of the data from the station under consideration.

  20. Limitations and implications of stream classification

    USGS Publications Warehouse

    Juracek, K.E.; Fitzpatrick, F.A.

    2003-01-01

    Stream classifications that are based on channel form, such as the Rosgen Level II classification, are useful tools for the physical description and grouping of streams and for providing a means of communication for stream studies involving scientists and (or) managers with different backgrounds. The Level II classification also is used as a tool to assess stream stability, infer geomorphic processes, predict future geomorphic response, and guide stream restoration or rehabilitation activities. The use of the Level II classification for these additional purposes is evaluated in this paper. Several examples are described to illustrate the limitations and management implications of the Level II classification. Limitations include: (1) time dependence, (2) uncertain applicability across physical environments, (3) difficulty in identification of a true equilibrium condition, (4) potential for incorrect determination of bankfull elevation, and (5) uncertain process significance of classification criteria. Implications of using stream classifications based on channel form, such as Rosgen's, include: (1) acceptance of the limitations, (2) acceptance of the risk of classifying streams incorrectly, and (3) classification results may be used inappropriately. It is concluded that use of the Level II classification for purposes beyond description and communication is not appropriate. Research needs are identified that, if addressed, may help improve the usefulness of the Level II classification.

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