21 CFR 860.84 - Classification procedures for “old devices.”
Code of Federal Regulations, 2010 CFR
2010-04-01
... Classification procedures for “old devices.” (a) This subpart sets forth the procedures for the original... the appropriate classification panel organized and operated in accordance with section 513 (b) and (c... set forth in § 860.7 relating to the determination of safety and effectiveness; (2) Determines the...
21 CFR 860.130 - General procedures under section 513(e) of the act.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE CLASSIFICATION PROCEDURES Reclassification § 860.130... reclassification proceedings under the act based upon new information. (b) A proceeding to reclassify a device... would provide reasonable assurance of the safety and effectiveness of the device and there is sufficient...
TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.
Henschke, Cornelia; Panteli, Dimitra; Perleth, Matthias; Busse, Reinhard
2015-01-01
The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.
21 CFR 862.1605 - Pregnanediol test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...
21 CFR 886.1380 - Diagnostic condensing lens.
Code of Federal Regulations, 2010 CFR
2010-04-01
... light from the fundus of the eye. (b) Classification. Class I (general controls). The device is exempt...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure...
Code of Federal Regulations, 2013 CFR
2013-04-01
... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...
Code of Federal Regulations, 2012 CFR
2012-04-01
... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...
Code of Federal Regulations, 2014 CFR
2014-04-01
... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...
Code of Federal Regulations, 2011 CFR
2011-04-01
... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...
Code of Federal Regulations, 2010 CFR
2010-04-01
... submitted in connection with classification and reclassification. 860.5 Section 860.5 Food and Drugs FOOD... DEVICE CLASSIFICATION PROCEDURES General § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification. (a) This section governs the availability...
21 CFR 872.6570 - Impression tube.
Code of Federal Regulations, 2010 CFR
2010-04-01
... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-13
... committee regarding classification of triple chamber pacing system analyzers (PSAs) with external pacing... chamber PSA is intended to be used during the implant procedure of pacemakers and defibrillators...
Gupta, Priyanka; Schomburg, John; Krishna, Suprita; Adejoro, Oluwakayode; Wang, Qi; Marsh, Benjamin; Nguyen, Andrew; Genere, Juan Reyes; Self, Patrick; Lund, Erik; Konety, Badrinath R
2017-01-01
To examine the Manufacturer and User Facility Device Experience Database (MAUDE) database to capture adverse events experienced with the Da Vinci Surgical System. In addition, to design a standardized classification system to categorize the complications and machine failures associated with the device. Overall, 1,057,000 DaVinci procedures were performed in the United States between 2009 and 2012. Currently, no system exists for classifying and comparing device-related errors and complications with which to evaluate adverse events associated with the Da Vinci Surgical System. The MAUDE database was queried for events reports related to the DaVinci Surgical System between the years 2009 and 2012. A classification system was developed and tested among 14 robotic surgeons to associate a level of severity with each event and its relationship to the DaVinci Surgical System. Events were then classified according to this system and examined by using Chi-square analysis. Two thousand eight hundred thirty-seven events were identified, of which 34% were obstetrics and gynecology (Ob/Gyn); 19%, urology; 11%, other; and 36%, not specified. Our classification system had moderate agreement with a Kappa score of 0.52. Using our classification system, we identified 75% of the events as mild, 18% as moderate, 4% as severe, and 3% as life threatening or resulting in death. Seventy-seven percent were classified as definitely related to the device, 15% as possibly related, and 8% as not related. Urology procedures compared with Ob/Gyn were associated with more severe events (38% vs 26%, p < 0.0001). Energy instruments were associated with less severe events compared with the surgical system (8% vs 87%, p < 0.0001). Events that were definitely associated with the device tended to be less severe (81% vs 19%, p < 0.0001). Our classification system is a valid tool with moderate inter-rater agreement that can be used to better understand device-related adverse events. The majority of robotic related events were mild but associated with the device.
21 CFR 864.6600 - Osmotic fragility test.
Code of Federal Regulations, 2011 CFR
2011-04-01
... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
21 CFR 864.6600 - Osmotic fragility test.
Code of Federal Regulations, 2012 CFR
2012-04-01
... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
21 CFR 864.6600 - Osmotic fragility test.
Code of Federal Regulations, 2014 CFR
2014-04-01
... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
21 CFR 864.6600 - Osmotic fragility test.
Code of Federal Regulations, 2013 CFR
2013-04-01
... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
21 CFR 864.6600 - Osmotic fragility test.
Code of Federal Regulations, 2010 CFR
2010-04-01
... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
Wu, Shang-Lin; Liao, Lun-De; Lu, Shao-Wei; Jiang, Wei-Ling; Chen, Shi-An; Lin, Chin-Teng
2013-08-01
Electrooculography (EOG) signals can be used to control human-computer interface (HCI) systems, if properly classified. The ability to measure and process these signals may help HCI users to overcome many of the physical limitations and inconveniences in daily life. However, there are currently no effective multidirectional classification methods for monitoring eye movements. Here, we describe a classification method used in a wireless EOG-based HCI device for detecting eye movements in eight directions. This device includes wireless EOG signal acquisition components, wet electrodes and an EOG signal classification algorithm. The EOG classification algorithm is based on extracting features from the electrical signals corresponding to eight directions of eye movement (up, down, left, right, up-left, down-left, up-right, and down-right) and blinking. The recognition and processing of these eight different features were achieved in real-life conditions, demonstrating that this device can reliably measure the features of EOG signals. This system and its classification procedure provide an effective method for identifying eye movements. Additionally, it may be applied to study eye functions in real-life conditions in the near future.
21 CFR 880.5630 - Nipple shield.
Code of Federal Regulations, 2011 CFR
2011-04-01
... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...
21 CFR 880.5630 - Nipple shield.
Code of Federal Regulations, 2013 CFR
2013-04-01
... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...
21 CFR 880.5630 - Nipple shield.
Code of Federal Regulations, 2014 CFR
2014-04-01
... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...
21 CFR 880.5630 - Nipple shield.
Code of Federal Regulations, 2010 CFR
2010-04-01
... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...
21 CFR 880.5630 - Nipple shield.
Code of Federal Regulations, 2012 CFR
2012-04-01
... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...
21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.
Code of Federal Regulations, 2012 CFR
2012-04-01
...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...
21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.
Code of Federal Regulations, 2011 CFR
2011-04-01
...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...
21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.
Code of Federal Regulations, 2014 CFR
2014-04-01
...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...
21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.
Code of Federal Regulations, 2013 CFR
2013-04-01
...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...
21 CFR 880.5090 - Liquid bandage.
Code of Federal Regulations, 2013 CFR
2013-04-01
... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...
21 CFR 880.5090 - Liquid bandage.
Code of Federal Regulations, 2011 CFR
2011-04-01
... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...
21 CFR 880.5090 - Liquid bandage.
Code of Federal Regulations, 2014 CFR
2014-04-01
... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...
21 CFR 880.5090 - Liquid bandage.
Code of Federal Regulations, 2012 CFR
2012-04-01
... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...
21 CFR 886.1200 - Optokinetic drum.
Code of Federal Regulations, 2010 CFR
2010-04-01
... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...
21 CFR 886.1200 - Optokinetic drum.
Code of Federal Regulations, 2011 CFR
2011-04-01
... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...
21 CFR 886.1200 - Optokinetic drum.
Code of Federal Regulations, 2014 CFR
2014-04-01
... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...
21 CFR 886.1200 - Optokinetic drum.
Code of Federal Regulations, 2013 CFR
2013-04-01
... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...
21 CFR 886.1200 - Optokinetic drum.
Code of Federal Regulations, 2012 CFR
2012-04-01
... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...
21 CFR 880.5090 - Liquid bandage.
Code of Federal Regulations, 2010 CFR
2010-04-01
... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...
21 CFR 864.3300 - Cytocentrifuge.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
21 CFR 864.3300 - Cytocentrifuge.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...
21 CFR 862.1560 - Urinary phenylketones (nonquantitative) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...
[Requirements for CE-marking of apps and wearables].
Berensmann, Michael; Gratzfeld, Markus
2018-03-01
Depending on the intended use, apps and wearables can be medical devices. In such cases, the manufacturer has to provide evidence that the requirements stated in directive 93/42/EWG are fulfilled. Depending on the classification of the medical device, several so-called conformity assessment procedures are possible. Once the conformity assessment procedure has been finished successfully, the manufacturer attaches the CE-marking to the product. This assures that all requirements of the directive have been fulfilled and the manufacturer is therefore authorized to put the product onto the market in all member states of the European union. In this article, the possible and practical conformity assessment procedures for apps and wearables are described and their implementation is outlined.For medical devices with sufficiently high-risk classification, the manufacturer has to involve a Notified Body. For the conformity assessment procedure according to annex II, the manufacturer implements a full quality management system and compiles technical documentation. These are supervised and evaluated by Notified Body audits. Especially for startups, it is important for the development of apps and wearables to implement a quality management system early and to fulfill the regulatory requirements, for example, related to the software life-cycle model. This also includes considering accompanying processes during development like risk management, usability engineering, and clinical evaluation.Additionally, it should be pointed out, that according to the new medical device regulation almost all apps will fall at least into class IIa. Thus, the involvement of a Notified Body in the related conformity assessment procedures would be required. Apps that have already been put onto the market as class I devices, and are now upgraded to a higher class, need the approval of a notified body starting from 26 May 2020.
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...
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...
21 CFR 874.1800 - Air or water caloric stimulator.
Code of Federal Regulations, 2010 CFR
2010-04-01
... vestibular function testing of a patient's body balance system. The vestibular stimulation of the...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...
21 CFR 868.1575 - Gas collection vessel.
Code of Federal Regulations, 2012 CFR
2012-04-01
... for subsequent analysis. It does not include a sampling pump. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...
21 CFR 876.5160 - Urological clamp for males.
Code of Federal Regulations, 2010 CFR
2010-04-01
... temporarily. It is an external clamp. (b) Classification. Class I (general controls). Except when intended for internal use or use on females, the device is exempt from the premarket notification procedures in subpart...
21 CFR 886.4070 - Powered corneal burr.
Code of Federal Regulations, 2013 CFR
2013-04-01
... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...
21 CFR 886.4070 - Powered corneal burr.
Code of Federal Regulations, 2011 CFR
2011-04-01
... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...
21 CFR 886.4070 - Powered corneal burr.
Code of Federal Regulations, 2014 CFR
2014-04-01
... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...
21 CFR 886.4070 - Powered corneal burr.
Code of Federal Regulations, 2010 CFR
2010-04-01
... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...
21 CFR 886.4070 - Powered corneal burr.
Code of Federal Regulations, 2012 CFR
2012-04-01
... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...
21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.
Code of Federal Regulations, 2012 CFR
2012-04-01
... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...
21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.
Code of Federal Regulations, 2014 CFR
2014-04-01
... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...
21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.
Code of Federal Regulations, 2013 CFR
2013-04-01
... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...
21 CFR 888.4800 - Template for clinical use.
Code of Federal Regulations, 2011 CFR
2011-04-01
... cutting. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR...
Chiarelli, Antonio Maria; Croce, Pierpaolo; Merla, Arcangelo; Zappasodi, Filippo
2018-06-01
Brain-computer interface (BCI) refers to procedures that link the central nervous system to a device. BCI was historically performed using electroencephalography (EEG). In the last years, encouraging results were obtained by combining EEG with other neuroimaging technologies, such as functional near infrared spectroscopy (fNIRS). A crucial step of BCI is brain state classification from recorded signal features. Deep artificial neural networks (DNNs) recently reached unprecedented complex classification outcomes. These performances were achieved through increased computational power, efficient learning algorithms, valuable activation functions, and restricted or back-fed neurons connections. By expecting significant overall BCI performances, we investigated the capabilities of combining EEG and fNIRS recordings with state-of-the-art deep learning procedures. We performed a guided left and right hand motor imagery task on 15 subjects with a fixed classification response time of 1 s and overall experiment length of 10 min. Left versus right classification accuracy of a DNN in the multi-modal recording modality was estimated and it was compared to standalone EEG and fNIRS and other classifiers. At a group level we obtained significant increase in performance when considering multi-modal recordings and DNN classifier with synergistic effect. BCI performances can be significantly improved by employing multi-modal recordings that provide electrical and hemodynamic brain activity information, in combination with advanced non-linear deep learning classification procedures.
NASA Astrophysics Data System (ADS)
Chiarelli, Antonio Maria; Croce, Pierpaolo; Merla, Arcangelo; Zappasodi, Filippo
2018-06-01
Objective. Brain–computer interface (BCI) refers to procedures that link the central nervous system to a device. BCI was historically performed using electroencephalography (EEG). In the last years, encouraging results were obtained by combining EEG with other neuroimaging technologies, such as functional near infrared spectroscopy (fNIRS). A crucial step of BCI is brain state classification from recorded signal features. Deep artificial neural networks (DNNs) recently reached unprecedented complex classification outcomes. These performances were achieved through increased computational power, efficient learning algorithms, valuable activation functions, and restricted or back-fed neurons connections. By expecting significant overall BCI performances, we investigated the capabilities of combining EEG and fNIRS recordings with state-of-the-art deep learning procedures. Approach. We performed a guided left and right hand motor imagery task on 15 subjects with a fixed classification response time of 1 s and overall experiment length of 10 min. Left versus right classification accuracy of a DNN in the multi-modal recording modality was estimated and it was compared to standalone EEG and fNIRS and other classifiers. Main results. At a group level we obtained significant increase in performance when considering multi-modal recordings and DNN classifier with synergistic effect. Significance. BCI performances can be significantly improved by employing multi-modal recordings that provide electrical and hemodynamic brain activity information, in combination with advanced non-linear deep learning classification procedures.
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...
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...
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...
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...
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...
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...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-15
... Administrator among the fields of hospital payment systems; hospital medical care delivery systems; provider billing and accounting systems; APC groups; Current Procedural Terminology codes; HCPCS codes; the use of, and payment for, drugs, medical devices, and other services in the outpatient setting; and other forms...
Keltie, Kim; Cole, Helen; Arber, Mick; Patrick, Hannah; Powell, John; Campbell, Bruce; Sims, Andrew
2014-11-28
Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes. The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.
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.
40 CFR 152.164 - Classification procedures.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Classification procedures. 152.164... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.164 Classification procedures. (a) Grouping of products for classification purposes. In its discretion, the Agency may identify...
40 CFR 152.164 - Classification procedures.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Classification procedures. 152.164... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.164 Classification procedures. (a) Grouping of products for classification purposes. In its discretion, the Agency may identify...
40 CFR 152.164 - Classification procedures.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Classification procedures. 152.164... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.164 Classification procedures. (a) Grouping of products for classification purposes. In its discretion, the Agency may identify...
40 CFR 152.164 - Classification procedures.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Classification procedures. 152.164... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.164 Classification procedures. (a) Grouping of products for classification purposes. In its discretion, the Agency may identify...
40 CFR 152.164 - Classification procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Classification procedures. 152.164... PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.164 Classification procedures. (a) Grouping of products for classification purposes. In its discretion, the Agency may identify...
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...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...
Ahmed, Afaz Uddin; Tariqul Islam, Mohammad; Ismail, Mahamod; Kibria, Salehin; Arshad, Haslina
2014-01-01
An artificial neural network (ANN) and affinity propagation (AP) algorithm based user categorization technique is presented. The proposed algorithm is designed for closed access femtocell network. ANN is used for user classification process and AP algorithm is used to optimize the ANN training process. AP selects the best possible training samples for faster ANN training cycle. The users are distinguished by using the difference of received signal strength in a multielement femtocell device. A previously developed directive microstrip antenna is used to configure the femtocell device. Simulation results show that, for a particular house pattern, the categorization technique without AP algorithm takes 5 indoor users and 10 outdoor users to attain an error-free operation. While integrating AP algorithm with ANN, the system takes 60% less training samples reducing the training time up to 50%. This procedure makes the femtocell more effective for closed access operation. PMID:25133214
Ahmed, Afaz Uddin; Islam, Mohammad Tariqul; Ismail, Mahamod; Kibria, Salehin; Arshad, Haslina
2014-01-01
An artificial neural network (ANN) and affinity propagation (AP) algorithm based user categorization technique is presented. The proposed algorithm is designed for closed access femtocell network. ANN is used for user classification process and AP algorithm is used to optimize the ANN training process. AP selects the best possible training samples for faster ANN training cycle. The users are distinguished by using the difference of received signal strength in a multielement femtocell device. A previously developed directive microstrip antenna is used to configure the femtocell device. Simulation results show that, for a particular house pattern, the categorization technique without AP algorithm takes 5 indoor users and 10 outdoor users to attain an error-free operation. While integrating AP algorithm with ANN, the system takes 60% less training samples reducing the training time up to 50%. This procedure makes the femtocell more effective for closed access operation.
7 CFR 27.34 - Classification procedure.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 7 Agriculture 2 2014-01-01 2014-01-01 false Classification procedure. 27.34 Section 27.34... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification and Micronaire Determinations § 27.34 Classification procedure. Classification shall proceed as rapidly as possible, but not...
7 CFR 27.34 - Classification procedure.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 7 Agriculture 2 2013-01-01 2013-01-01 false Classification procedure. 27.34 Section 27.34... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification and Micronaire Determinations § 27.34 Classification procedure. Classification shall proceed as rapidly as possible, but not...
7 CFR 27.34 - Classification procedure.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 7 Agriculture 2 2012-01-01 2012-01-01 false Classification procedure. 27.34 Section 27.34... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification and Micronaire Determinations § 27.34 Classification procedure. Classification shall proceed as rapidly as possible, but not...
7 CFR 27.34 - Classification procedure.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 7 Agriculture 2 2011-01-01 2011-01-01 false Classification procedure. 27.34 Section 27.34... REGULATIONS COTTON CLASSIFICATION UNDER COTTON FUTURES LEGISLATION Regulations Classification and Micronaire Determinations § 27.34 Classification procedure. Classification shall proceed as rapidly as possible, but not...
21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...
21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...
21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...
21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...
21 CFR 860.93 - Classification of implants, life-supporting or life-sustaining devices.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Classification of implants, life-supporting or life-sustaining devices. 860.93 Section 860.93 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Classification § 860.93 Classification of implants, life-supporting or life-sustaining devices. (a) The...
Code of Federal Regulations, 2010 CFR
2010-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...) of the act with respect to the classification and reclassification of devices intended for human use... information submitted to classification panels or to the Commissioner in connection with classification and...
Code of Federal Regulations, 2011 CFR
2011-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE...) of the act with respect to the classification and reclassification of devices intended for human use... information submitted to classification panels or to the Commissioner in connection with classification and...
78 FR 68983 - Cotton Futures Classification: Optional Classification Procedure
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-18
...-AD33 Cotton Futures Classification: Optional Classification Procedure AGENCY: Agricultural Marketing... regulations to allow for the addition of an optional cotton futures classification procedure--identified and known as ``registration'' by the U.S. cotton industry and the Intercontinental Exchange (ICE). In...
76 FR 60388 - Revision of Cotton Futures Classification Procedures
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-29
...-005] RIN 0581-AD16 Revision of Cotton Futures Classification Procedures AGENCY: Agricultural Marketing... update the procedures for cotton futures quality classification services by using Smith-Doxey classification data in the cotton futures classification process. In addition, references to a separate and...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-24
...; Clarification of Classification for Human Dura Mater; Technical Amendment AGENCY: Food and Drug Administration... amending the device regulations to clarify the applicability of the device classification for human dura..., human dura mater is now defined under 21 CFR 1271.3(d) as a HCT/P. As such, it is regulated under...
28 CFR 524.73 - Classification procedures.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Classification procedures. 524.73 Section..., CLASSIFICATION, AND TRANSFER CLASSIFICATION OF INMATES Central Inmate Monitoring (CIM) System § 524.73 Classification procedures. (a) Initial assignment. Except as provided for in paragraphs (a) (1) through (4) of...
28 CFR 524.73 - Classification procedures.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Classification procedures. 524.73 Section..., CLASSIFICATION, AND TRANSFER CLASSIFICATION OF INMATES Central Inmate Monitoring (CIM) System § 524.73 Classification procedures. (a) Initial assignment. Except as provided for in paragraphs (a) (1) through (4) of...
28 CFR 524.73 - Classification procedures.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Classification procedures. 524.73 Section..., CLASSIFICATION, AND TRANSFER CLASSIFICATION OF INMATES Central Inmate Monitoring (CIM) System § 524.73 Classification procedures. (a) Initial assignment. Except as provided for in paragraphs (a) (1) through (4) of...
28 CFR 524.73 - Classification procedures.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Classification procedures. 524.73 Section..., CLASSIFICATION, AND TRANSFER CLASSIFICATION OF INMATES Central Inmate Monitoring (CIM) System § 524.73 Classification procedures. (a) Initial assignment. Except as provided for in paragraphs (a) (1) through (4) of...
Closure of patent foramen ovale: when and how?
Lisignoli, Veronica; Lanzone, Alberto M; Zavalloni, Dennis; Pagnotta, Paolo; Presbitero, Patrizia
2007-10-01
Percutaneous closure of a patent foramen ovale (PFO) was performed in 98 consecutive patients (mean age 52.5 +/- 13 years, 61 women). Indications included recurrent transient ischaemic attack (47%), cryptogenic stroke (34%), peripheral embolism (11%), disabling migraine with aura (4%), professional scuba diving (1 pt) and severe platypnea-orthodeoxia syndrome (1 pt). Each PFO was characterized by transesophageal echocardiography (TEE) according to anatomy, degree of shunt (1-mild, 2-moderate, 3-severe), right atrial anatomical features relevant for PFO closure (such as presence of an Eustachian valve, Chiari network, lipomatosis or absence of septum secundum) with a new classification scheme. According to this classification successful device delivery was obtained in 100% of pts. Major complications included heparin-induced thrombocytopenia in 1 pt and device dislodgment in 1 pt; minor complications were mostly related to the catheter introduction site (2 pts) and mild immediate shunt (2 pts). In conclusion, percutaneous PFO closure based on strict anatomic criteria is a safe procedure with minimal periprocedural complications.
An automatic agricultural zone classification procedure for crop inventory satellite images
NASA Technical Reports Server (NTRS)
Parada, N. D. J. (Principal Investigator); Kux, H. J.; Velasco, F. R. D.; Deoliveira, M. O. B.
1982-01-01
A classification procedure for assessing crop areal proportion in multispectral scanner image is discussed. The procedure is into four parts: labeling; classification; proportion estimation; and evaluation. The procedure also has the following characteristics: multitemporal classification; the need for a minimum field information; and verification capability between automatic classification and analyst labeling. The processing steps and the main algorithms involved are discussed. An outlook on the future of this technology is also presented.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-18
.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...
Anderson, Ted L; Yunker, Amanda C; Scheib, Stacey A; Callahan, Tamara L
2013-01-01
To determine factors associated with hysteroscopic sterilization success and whether it differs between the operating room and office settings. Retrospective cohort analysis (Canadian Task Force classification II-2). Major university medical center. Six hundred thirty-eight women who underwent hysteroscopic sterilization between July 1, 2005, and June 30, 2011. Data collected included age, body mass index, previous office procedures, previous cesarean section, and presence of myomas or retroverted uterus. Place of surgery, experience of surgeon, insurance type, bilateral device placement, compliance with hysterosalpingography, and confirmation of occlusion were also recorded. Bivariate analysis of patient characteristics between groups was performed using χ(2) and independent t tests, and identified confounders and associated variables. Multivariate analysis was performed using logistic regression to assess for association and to adjust for confounders. Procedures were performed in the operating room (57%) or in the office (43%). There was no association between success in bilateral device placement or occlusion and any patient characteristic, regardless of surgery setting. Private insurance, patient age, and performance of procedures in the office setting were positively associated with likelihood of compliance with hysterosalpingography. Successful device placement and tubal occlusion are independent of patient age, body mass index, or setting of the procedure. Association between insurance type and completing hysterosalpingography illustrates an important public health problem. Patients who fail to undergo hysterosalpingography to confirm tubal occlusion may unknowingly be at risk of pregnancy and increased risk of ectopic pregnancy. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...
Grant, Angeline; Njiru, James; Okoth, Edgar; Awino, Imelda; Briend, André; Murage, Samuel; Abdirahman, Saida; Myatt, Mark
2018-01-01
A novel approach for improving community case-detection of acute malnutrition involves mothers/caregivers screening their children for acute malnutrition using a mid-upper arm circumference (MUAC) insertion tape. The objective of this study was to test three simple MUAC classification devices to determine whether they improved the sensitivity of mothers/caregivers at detecting acute malnutrition. Prospective, non-randomised, partially-blinded, clinical diagnostic trial describing and comparing the performance of three "Click-MUAC" devices and a MUAC insertion tape. The study took place in twenty-one health facilities providing integrated management of acute malnutrition (IMAM) services in Isiolo County, Kenya. Mothers/caregivers classified their child ( n =1040), aged 6-59 months, using the "Click-MUAC" devices and a MUAC insertion tape. These classifications were compared to a "gold standard" classification (the mean of three measurements taken by a research assistant using the MUAC insertion tape). The sensitivity of mother/caregiver classifications was high for all devices (>93% for severe acute malnutrition (SAM), defined by MUAC < 115 mm, and > 90% for global acute malnutrition (GAM), defined by MUAC < 125 mm). Mother/caregiver sensitivity for SAM and GAM classification was higher using the MUAC insertion tape (100% sensitivity for SAM and 99% sensitivity for GAM) than using "Click-MUAC" devices. Younden's J for SAM classification, and sensitivity for GAM classification, were significantly higher for the MUAC insertion tape (99% and 99% respectively). Specificity was high for all devices (>96%) with no significant difference between the "Click-MUAC" devices and the MUAC insertion tape. The results of this study indicate that, although the "Click-MUAC" devices performed well, the MUAC insertion tape performed best. The results for sensitivity are higher than found in previous studies. The high sensitivity for both SAM and GAM classification by mothers/caregivers with the MUAC insertion tape could be due to the use of an improved MUAC tape design which has a number of new design features. The one-on-one demonstration provided to mothers/caregivers on the use of the devices may also have helped improve sensitivity. The results of this study provide evidence that mothers/caregivers can perform sensitive and specific classifications of their child's nutritional status using MUAC. Clinical trials registration number: NCT02833740.
48 CFR 245.201-73 - Security classification.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Security classification... Procedures 245.201-73 Security classification. Follow the procedures at PGI 245.201-73 for security classification. ...
48 CFR 245.201-73 - Security classification.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Security classification... Procedures 245.201-73 Security classification. Follow the procedures at PGI 245.201-73 for security classification. ...
Medical applications of near-eye display devices: an exploratory study.
Vorraber, Wolfgang; Voessner, Siegfried; Stark, Gerhard; Neubacher, Dietmar; DeMello, Steven; Bair, Aaron
2014-12-01
Near-eye display devices (such as Google Glass) may improve the efficiency and effectiveness of clinical care by giving clinicians information (such as the patient's vital signs) continuously within their field of vision during various procedures. We describe the use of Glass during a radiological intervention in three patients. Other possible applications (including tele-mentoring and the supervision of trainees) are discussed and a classification proposed. An app was developed to facilitate the use of Glass, so vital physical signs (pulse and blood pressure) could be projected on the near-eye display, via an intranet to protect sensitive data. The device was then used during radiological interventions (percutaneous transluminal angioplasty) in three patients, and assessed by the interventionalists who were interviewed before and after each procedure. The interventionalists reported that Google Glass improved concentration on the task in hand by reducing head and neck movements (which would be needed to view several remote monitors). However, heat generation by the device and low battery capacity are shortcomings for which solutions must be developed, and data protection is mandatory. Google Glass may have a number of clinical applications and can quicken interventions where vital signs or other visual data need to be monitored by the operator. Copyright © 2014 Surgical Associates Ltd. All rights reserved.
77 FR 5379 - Revision of Cotton Futures Classification Procedures
Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-03
... 0581-AD16 Revision of Cotton Futures Classification Procedures AGENCY: Agricultural Marketing Service... for cotton futures quality classification services by using Smith-Doxey classification data in the cotton futures classification process. In addition, references to a separate and optional review of...
49 CFR 8.19 - Procedures for submitting and processing requests for classification reviews.
Code of Federal Regulations, 2011 CFR
2011-10-01
... for classification reviews. 8.19 Section 8.19 Transportation Office of the Secretary of Transportation CLASSIFIED INFORMATION: CLASSIFICATION/DECLASSIFICATION/ACCESS Classification/Declassification of Information § 8.19 Procedures for submitting and processing requests for classification reviews. (a) The Director...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...
NASA Technical Reports Server (NTRS)
Carnes, J. G.; Baird, J. E. (Principal Investigator)
1980-01-01
The classification procedure utilized in making crop proportion estimates for corn and soybeans using remotely sensed data was evaluated. The procedure was derived during the transition year of the Large Area Crop Inventory Experiment. Analysis of variance techniques were applied to classifications performed by 3 groups of analysts who processed 25 segments selected from 4 agrophysical units (APU's). Group and APU effects were assessed to determine factors which affected the quality of the classifications. The classification results were studied to determine the effectiveness of the procedure in producing corn and soybeans proportion estimates.
Kiran, Viralam S; Tiwari, Ashish
2018-04-06
The aims of this study were to determine the incidence and correlates of left ventricular (LV) dysfunction amongst percutaneous patent ductus arteriosus (PDA) device closure patients, and to propose an indexed parameter for predicting LV dysfunction. In a retrospective cross-sectional analysis of 30 months duration, 447 patients who underwent PDA device closure were studied. The diameter of the PDA at the pulmonary artery end was measured in the angiograms in all patients and was indexed for their body surface area. The indexed PDA size was categorised into group A (1-2.9 mm/m², 35/447), B (3-5.9 mm/m², 254/447), C (6-8.9 mm/m², 66/447) and D (>9 mm/m², 35/447). Systolic LV function was evaluated using echocardiography at frequent intervals. Overall, 62.63% of the patients were female (280/447). At baseline, all 447 patients had normal LV function. LV dysfunction was seen in 102/447 (22.8%) patients with 2.8% in category A (1/35), 10.6% in category B (27/254), 34.1% in category C (42/123) and 91.4% in category D (32/35) after PDA device closure. Correlation of indexed PDA size and LV dysfunction was statistically significant (p<0.05). Accurate prediction of LV dysfunction is important in risk stratification, ICU management and counselling in PDA device closures. Indexed PDA size correlates well with post-procedural LV dysfunction. The authors propose a new classification of PDA utilising this accurate, reproducible and easy to perform parameter, which does not involve any extra cost, for risk stratification and early management in device closure of PDA.
2012-01-01
Background Procedures documented by general practitioners in primary care have not been studied in relation to procedure coding systems. We aimed to describe procedures documented by Swedish general practitioners in electronic patient records and to compare them to the Swedish Classification of Health Interventions (KVÅ) and SNOMED CT. Methods Procedures in 200 record entries were identified, coded, assessed in relation to two procedure coding systems and analysed. Results 417 procedures found in the 200 electronic patient record entries were coded with 36 different Classification of Health Interventions categories and 148 different SNOMED CT concepts. 22.8% of the procedures could not be coded with any Classification of Health Interventions category and 4.3% could not be coded with any SNOMED CT concept. 206 procedure-concept/category pairs were assessed as a complete match in SNOMED CT compared to 10 in the Classification of Health Interventions. Conclusions Procedures documented by general practitioners were present in nearly all electronic patient record entries. Almost all procedures could be coded using SNOMED CT. Classification of Health Interventions covered the procedures to a lesser extent and with a much lower degree of concordance. SNOMED CT is a more flexible terminology system that can be used for different purposes for procedure coding in primary care. PMID:22230095
10 CFR 1045.8 - Procedural exemptions.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Classification. (b) A request for an exemption shall be made in writing to the Director of Classification and... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NUCLEAR CLASSIFICATION AND DECLASSIFICATION Program Management of the Restricted Data and Formerly Restricted Data Classification System § 1045.8 Procedural exemptions...
10 CFR 1045.8 - Procedural exemptions.
Code of Federal Regulations, 2011 CFR
2011-01-01
... Classification. (b) A request for an exemption shall be made in writing to the Director of Classification and... DEPARTMENT OF ENERGY (GENERAL PROVISIONS) NUCLEAR CLASSIFICATION AND DECLASSIFICATION Program Management of the Restricted Data and Formerly Restricted Data Classification System § 1045.8 Procedural exemptions...
77 FR 20503 - Revision of Cotton Classification Procedures for Determining Cotton Leaf Grade
Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-05
...-AD19 Revision of Cotton Classification Procedures for Determining Cotton Leaf Grade AGENCY... amending the procedures for determining the official leaf grade for Upland and Pima cotton. The leaf grade is a part of the official classification which denotes cotton fiber quality used in cotton marketing...
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.
12 CFR 1229.12 - Procedures related to capital classification and other actions.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Procedures related to capital classification and other actions. 1229.12 Section 1229.12 Banks and Banking FEDERAL HOUSING FINANCE AGENCY ENTITY REGULATIONS CAPITAL CLASSIFICATIONS AND PROMPT CORRECTIVE ACTION Federal Home Loan Banks § 1229.12 Procedures...
48 CFR 245.201-71 - Security classification.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Security classification... Procedures 245.201-71 Security classification. Follow the procedures at PGI 245.201-71 for security classification. [76 FR 3537, Jan. 20, 2011. Redesignated and amended at 77 FR 76937, Dec. 31, 2012] ...
48 CFR 245.201-71 - Security classification.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Security classification... Procedures 245.201-71 Security classification. Follow the procedures at PGI 245.201-71 for security classification. [76 FR 3537, Jan. 20, 2011. Redesignated and amended at 77 FR 76937, Dec. 31, 2012] ...
Formalizing the Austrian Procedure Catalogue: A 4-step methodological analysis approach.
Neururer, Sabrina Barbara; Lasierra, Nelia; Peiffer, Karl Peter; Fensel, Dieter
2016-04-01
Due to the lack of an internationally accepted and adopted standard for coding health interventions, Austria has established its own country-specific procedure classification system - the Austrian Procedure Catalogue (APC). Even though the APC is an elaborate coding standard for medical procedures, it has shortcomings that limit its usability. In order to enhance usability and usefulness, especially for research purposes and e-health applications, we developed an ontologized version of the APC. In this paper we present a novel four-step approach for the ontology engineering process, which enables accurate extraction of relevant concepts for medical ontologies from written text. The proposed approach for formalizing the APC consists of the following four steps: (1) comparative pre-analysis, (2) definition analysis, (3) typological analysis, and (4) ontology implementation. The first step contained a comparison of the APC to other well-established or elaborate health intervention coding systems in order to identify strengths and weaknesses of the APC. In the second step, a list of definitions of medical terminology used in the APC was obtained. This list of definitions was used as input for Step 3, in which we identified the most important concepts to describe medical procedures using the qualitative typological analysis approach. The definition analysis as well as the typological analysis are well-known and effective methods used in social sciences, but not commonly employed in the computer science or ontology engineering domain. Finally, this list of concepts was used in Step 4 to formalize the APC. The pre-analysis highlighted the major shortcomings of the APC, such as the lack of formal definition, leading to implicitly available, but not directly accessible information (hidden data), or the poor procedural type classification. After performing the definition and subsequent typological analyses, we were able to identify the following main characteristics of health interventions: (1) Procedural type, (2) Anatomical site, (3) Medical device, (4) Pathology, (5) Access, (6) Body system, (7) Population, (8) Aim, (9) Discipline, (10) Technique, and (11) Body Function. These main characteristics were taken as input of classes for the formalization of the APC. We were also able to identify relevant relations between classes. The proposed four-step approach for formalizing the APC provides a novel, systematically developed, strong framework to semantically enrich procedure classifications. Although this methodology was designed to address the particularities of the APC, the included methods are based on generic analysis tasks, and therefore can be re-used to provide a systematic representation of other procedure catalogs or classification systems and hence contribute towards a universal alignment of such representations, if desired. Copyright © 2015 Elsevier Inc. All rights reserved.
Engagement Assessment Using EEG Signals
NASA Technical Reports Server (NTRS)
Li, Feng; Li, Jiang; McKenzie, Frederic; Zhang, Guangfan; Wang, Wei; Pepe, Aaron; Xu, Roger; Schnell, Thomas; Anderson, Nick; Heitkamp, Dean
2012-01-01
In this paper, we present methods to analyze and improve an EEG-based engagement assessment approach, consisting of data preprocessing, feature extraction and engagement state classification. During data preprocessing, spikes, baseline drift and saturation caused by recording devices in EEG signals are identified and eliminated, and a wavelet based method is utilized to remove ocular and muscular artifacts in the EEG recordings. In feature extraction, power spectrum densities with 1 Hz bin are calculated as features, and these features are analyzed using the Fisher score and the one way ANOVA method. In the classification step, a committee classifier is trained based on the extracted features to assess engagement status. Finally, experiment results showed that there exist significant differences in the extracted features among different subjects, and we have implemented a feature normalization procedure to mitigate the differences and significantly improved the engagement assessment performance.
78 FR 54970 - Cotton Futures Classification: Optional Classification Procedure
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-09
... Service 7 CFR Part 27 [AMS-CN-13-0043] RIN 0581-AD33 Cotton Futures Classification: Optional... optional cotton futures classification procedure--identified and known as ``registration'' by the U.S. cotton industry and the Intercontinental Exchange (ICE). In response to requests from the U.S. cotton...
Analysis of emboli during carotid stenting with distal protection device.
Chen, Chin-I; Iguchi, Yasuyuki; Garami, Zsolt; Malkoff, Marc D; Smalling, Richard W; Campbell, Morgan S; Alexandrov, Andrei V
2006-01-01
The newly developed multi-frequency transcranial Doppler (TCD) is able to differentiate gaseous from solid emboli. Our goal was to apply this technology to initially characterize emboli detected during carotid stenting with distal protection. Patients undergoing carotid angiography and stenting were monitored with 2-2.5 MHz TCD (Embo-Dop, DWL) over the middle cerebral artery unilateral to stent deployment. Sonographers insured optimal signal recordings during the procedures. Automated emboli detection and classification software (MultiXLab version 2.0) was applied for offline count and analysis. Monitoring using the Filter Wire EX (Boston Scientific) and ACCUNET system (Guidant Corporation) was performed. A total of 9,649 embolic signals were detected during 11 angiographic and 10 stenting procedures. An observer confirmed the signals using the International Consensus definition. Automated software classified these events into 5,900 gaseous and 3,749 solid emboli. During contrast injections without the protection device, 1,013 emboli were detected with 28% of these being solid. With deployment of the distal protection device, 8,636 emboli were found with 40% being solid (p < 0.001). During stenting and angioplasty with the protection device, 7,395 emboli with 42% solids were detected (p < 0.001). Finally injection of contrast after the procedure, with the protection device still deployed, yielded 1,241 emboli with 31% solids (NS). Only 1 patient developed transient hemiparesthesia during ballooning that reduced the flow velocity to zero for 14 s. Neither gaseous nor solid emboli resulted in a mean flow velocity decrease or clinical symptoms. Microembolization frequently occurs during stenting even with deployment of the distal protection device. More solid emboli are seen during manipulations associated with lesion crossing. Although novel TCD methods yield a high frequency of embolic signals, further validation of this technique to determine the true nature, size, and number of emboli is needed.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-11
... Classification Elections. DATES: Written comments should be received on or before May 10, 2011 to be assured of... Classification Elections. OMB Number: 1545-1771. Revenue Procedure Number: Revenue Procedure 2009-41. (Rev. Proc... Internal Revenue Code for an eligible entity that requests relief for a late classification election filed...
Some sequential, distribution-free pattern classification procedures with applications
NASA Technical Reports Server (NTRS)
Poage, J. L.
1971-01-01
Some sequential, distribution-free pattern classification techniques are presented. The decision problem to which the proposed classification methods are applied is that of discriminating between two kinds of electroencephalogram responses recorded from a human subject: spontaneous EEG and EEG driven by a stroboscopic light stimulus at the alpha frequency. The classification procedures proposed make use of the theory of order statistics. Estimates of the probabilities of misclassification are given. The procedures were tested on Gaussian samples and the EEG responses.
12 CFR 605.502 - Program and procedures.
Code of Federal Regulations, 2013 CFR
2013-01-01
... procedures. (a) The Farm Credit Administration has no authority for the original classification of... classify information. (b) Derivative classification. “Derivative classification” means the incorporating... developed material consistent with the classification markings that apply to the source information...
12 CFR 605.502 - Program and procedures.
Code of Federal Regulations, 2014 CFR
2014-01-01
... procedures. (a) The Farm Credit Administration has no authority for the original classification of... classify information. (b) Derivative classification. “Derivative classification” means the incorporating... developed material consistent with the classification markings that apply to the source information...
12 CFR 605.502 - Program and procedures.
Code of Federal Regulations, 2011 CFR
2011-01-01
... procedures. (a) The Farm Credit Administration has no authority for the original classification of... classify information. (b) Derivative classification. “Derivative classification” means the incorporating... developed material consistent with the classification markings that apply to the source information...
12 CFR 605.502 - Program and procedures.
Code of Federal Regulations, 2012 CFR
2012-01-01
... procedures. (a) The Farm Credit Administration has no authority for the original classification of... classify information. (b) Derivative classification. “Derivative classification” means the incorporating... developed material consistent with the classification markings that apply to the source information...
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...
[EYECUBE as 3D multimedia imaging in macular diagnostics].
Hassenstein, Andrea; Scholz, F; Richard, G
2011-11-01
In the new generation of EYECUBE devices, the angiography image and the OCT are included in a 3D illustration as an integration. Other diagnostic procedures such as autofluorescence and ICG can also be correlated to the OCT. The aim was to precisely classify various two-dimensional findings in relation to each other. The new generation of OCT devices enables imaging with a low incidence of motion artefacts with very good fundus image quality - and with that, permits a largely automatic classification. The feature enabling the integration of the EYECUBE was further developed with new software, so that not only the topographic image (red-free, autofluorescence) can be correlated to the Cirrus OCT, but also all other findings gathered within the same time frame can be correlated to each other. These were brightened and projected onto the cube surface in a defined interval. The imaging procedures can be selected in a menu toolbar. Topographic volumetry OCT images can be overlayed. The practical application of the new method was tested on patients with macular disorders. By lightening up the results from various diagnostic procedures, it is possible of late to directly compare pathologies to each other and to the OCT results. In all patients (n = 45 eyes) with good single-image quality, the automated integration into the EYECUBE was possible (to a great extent). The application is not dependent on a certain type of device used in the procedures performed. The increasing level of precision in imaging procedures and the handling of large data volumes has led to the possibility of examining each macular diagnostics procedure from the comparative perspective: imaging (photo) with perfusion (FLA, ICG) and morphology (OCT). The exclusion of motion artefacts and the reliable scan position in the course of the imaging process increases the informative value of OCT. © Georg Thieme Verlag KG Stuttgart · New York.
NASA Technical Reports Server (NTRS)
Justice, C.; Townshend, J. (Principal Investigator)
1981-01-01
Two unsupervised classification procedures were applied to ratioed and unratioed LANDSAT multispectral scanner data of an area of spatially complex vegetation and terrain. An objective accuracy assessment was undertaken on each classification and comparison was made of the classification accuracies. The two unsupervised procedures use the same clustering algorithm. By on procedure the entire area is clustered and by the other a representative sample of the area is clustered and the resulting statistics are extrapolated to the remaining area using a maximum likelihood classifier. Explanation is given of the major steps in the classification procedures including image preprocessing; classification; interpretation of cluster classes; and accuracy assessment. Of the four classifications undertaken, the monocluster block approach on the unratioed data gave the highest accuracy of 80% for five coarse cover classes. This accuracy was increased to 84% by applying a 3 x 3 contextual filter to the classified image. A detailed description and partial explanation is provided for the major misclassification. The classification of the unratioed data produced higher percentage accuracies than for the ratioed data and the monocluster block approach gave higher accuracies than clustering the entire area. The moncluster block approach was additionally the most economical in terms of computing time.
Correlation-based pattern recognition for implantable defibrillators.
Wilkins, J.
1996-01-01
An estimated 300,000 Americans die each year from cardiac arrhythmias. Historically, drug therapy or surgery were the only treatment options available for patients suffering from arrhythmias. Recently, implantable arrhythmia management devices have been developed. These devices allow abnormal cardiac rhythms to be sensed and corrected in vivo. Proper arrhythmia classification is critical to selecting the appropriate therapeutic intervention. The classification problem is made more challenging by the power/computation constraints imposed by the short battery life of implantable devices. Current devices utilize heart rate-based classification algorithms. Although easy to implement, rate-based approaches have unacceptably high error rates in distinguishing supraventricular tachycardia (SVT) from ventricular tachycardia (VT). Conventional morphology assessment techniques used in ECG analysis often require too much computation to be practical for implantable devices. In this paper, a computationally-efficient, arrhythmia classification architecture using correlation-based morphology assessment is presented. The architecture classifies individuals heart beats by assessing similarity between an incoming cardiac signal vector and a series of prestored class templates. A series of these beat classifications are used to make an overall rhythm assessment. The system makes use of several new results in the field of pattern recognition. The resulting system achieved excellent accuracy in discriminating SVT and VT. PMID:8947674
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.
75 FR 9955 - Labor Surplus Area Classification Under Executive Orders 12073 and 10582
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-04
... DEPARTMENT OF LABOR Employment and Training Administration Labor Surplus Area Classification Under Executive Orders 12073 and 10582 AGENCY: Employment and Training Administration, Labor. ACTION: Notice... supplementary, eligibility, classification procedures and petition for exceptional circumstances procedure...
76 FR 43582 - Cardiovascular Devices; Classification of Electrocardiograph Electrodes
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308) Cardiovascular Devices; Classification of... amended as follows: [[Page 43585
Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-03
... medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for... assist that office in processing your request, or fax your request to CDRH at (301) 847-8149. The draft... parts 862 through 892)) have been the basis for the CDRH's Classification Product Code structure and...
Girón, Joel; Gil-Sánchez, Luís; García-Breijo, Eduardo; Pagán, M Jesús; Barat, José M; Grau, Raúl
2015-08-01
Microbiological contamination in dry-cured ham can occur in the early stages of the process, a large number of microorganisms involved in spoilage can produce alterations in the product. These include non-common odours, which are detected at the end of the process by a procedure called "cala", consisting of a sharp instrument punctured in every ham; this is smelled by an expert taster, who classifies hams as good and altered hams. An electronic device would be suitable for this process given the large amount of hams. The present research aims to develop objective equipment based on the potentiometry technique that identifies altered hams. A probe was developed, containing silver, nickel and copper electrodes, and was employed to classify altered and unaltered hams prior to classification by a tester. The results shown lower Ag and higher Cu potential values for altered hams. The differences in potentiometric response reveal a classification model, although further studies are required to obtain a reliable classification model. Copyright © 2015 Elsevier Ltd. All rights reserved.
On Biometrics With Eye Movements.
Zhang, Youming; Juhola, Martti
2017-09-01
Eye movements are a relatively novel data source for biometric identification. When video cameras applied to eye tracking become smaller and more efficient, this data source could offer interesting opportunities for the development of eye movement biometrics. In this paper, we study primarily biometric identification as seen as a classification task of multiple classes, and secondarily biometric verification considered as binary classification. Our research is based on the saccadic eye movement signal measurements from 109 young subjects. In order to test the data measured, we use a procedure of biometric identification according to the one-versus-one (subject) principle. In a development from our previous research, which also involved biometric verification based on saccadic eye movements, we now apply another eye movement tracker device with a higher sampling frequency of 250 Hz. The results obtained are good, with correct identification rates at 80-90% at their best.
NASA Technical Reports Server (NTRS)
Hepner, George F.; Logan, Thomas; Ritter, Niles; Bryant, Nevin
1990-01-01
Recent research has shown an artificial neural network (ANN) to be capable of pattern recognition and the classification of image data. This paper examines the potential for the application of neural network computing to satellite image processing. A second objective is to provide a preliminary comparison and ANN classification. An artificial neural network can be trained to do land-cover classification of satellite imagery using selected sites representative of each class in a manner similar to conventional supervised classification. One of the major problems associated with recognition and classifications of pattern from remotely sensed data is the time and cost of developing a set of training sites. This reseach compares the use of an ANN back propagation classification procedure with a conventional supervised maximum likelihood classification procedure using a minimal training set. When using a minimal training set, the neural network is able to provide a land-cover classification superior to the classification derived from the conventional classification procedure. This research is the foundation for developing application parameters for further prototyping of software and hardware implementations for artificial neural networks in satellite image and geographic information processing.
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.
Kiringoda, Ruwan; Thurm, Audrey E; Hirschtritt, Matthew E; Koziol, Deloris; Wesley, Robert; Swedo, Susan E; O'Grady, Naomi P; Quezado, Zenaide M N
2010-06-01
To quantify the incidence of adverse events associated with anesthesia given for research-driven imaging studies and to identify risk factors for those events in pediatric research subjects. Retrospective cohort study. National Institutes of Health Clinical Center. Children and adolescents enrolled in clinical research protocols who required anesthesia for research-related imaging studies from January 2000 to September 2008. Propofol sedation/anesthesia. The occurrence of respiratory, cardiovascular, and all anesthesia-related adverse events that required intervention while receiving anesthetics for research-driven imaging studies and other noninvasive procedures. We identified 607 children who received 1480 propofol anesthetic procedures for imaging studies. Seventy percent of anesthetics were given to subjects with severe diseases and significant disabilities (American Society of Anesthesiologists Physical Status [ASA] III). Anesthesia had a mean (SD) duration of 115 (55) minutes, and in 12.5% of procedures, an airway device was necessary. There were 98 notable respiratory, cardiovascular, and other events in 79 anesthetic procedures, a rate of 534 per 10 000 anesthetic procedures with 1 or more adverse events. There was no long-lasting morbidity or mortality. The ASA classification (odds ratio [OR], 2.92; 95% confidence interval [CI], 1.24-6.88), anesthetic effect duration (OR, 1.46; 95% CI, 1.25-1.70), and presence of airway abnormalities (OR, 4.41; 95% CI, 1.60-12.12) were independently associated with adverse events during anesthetic use. In our clinical research sample of high-risk children who received sedation/anesthesia by an anesthesiologist, we observed a low incidence of adverse events and no long-term complications. Risk factors for adverse events included higher ASA classification, increasing anesthetic duration, and presence of airway abnormalities.
Gossman, Michael S; Wilkinson, Jeffrey D; Mallick, Avishek
2014-01-01
In a 2-part study, we first examined the results of 71 surveyed physicians who provided responses on how they address the management of patients who maintained either a pacemaker or a defibrillator during radiation treatment. Second, a case review study is presented involving 112 medical records reviewed at 18 institutions to determine whether there was a change in the radiation prescription for the treatment of the target cancer, the method of radiation delivery, or the method of radiation image acquisition. Statistics are provided to illustrate the level of administrative policy; the level of communication between radiation oncologists and heart specialists; American Joint Committee on Cancer (AJCC) staging and classification; National Comprehensive Cancer Network (NCCN) guidelines; tumor site; patient׳s sex; patient׳s age; device type; manufacturer; live monitoring; and the reported decisions for planning, delivery, and imaging. This survey revealed that 37% of patient treatments were considered for some sort of change in this regard, whereas 59% of patients were treated without regard to these alternatives when available. Only 3% of all patients were identified with an observable change in the functionality of the device or patient status in comparison with 96% of patients with normal behavior and operating devices. Documented changes in the patient׳s medical record included 1 device exhibiting failure at 0.3-Gy dose, 1 device exhibiting increased sensor rate during dose delivery, 1 patient having an irregular heartbeat leading to device reprogramming, and 1 patient complained of twinging in the chest wall that resulted in a respiratory arrest. Although policies and procedures should directly involve the qualified medical physicist for technical supervision, their sufficient involvement was typically not requested by most respondents. No treatment options were denied to any patient based on AJCC staging, classification, or NCCN practice standards. Copyright © 2014 American Association of Medical Dosimetrists. Published by Elsevier Inc. All rights reserved.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Gossman, Michael S., E-mail: MGossman@TSRCC.com; Wilkinson, Jeffrey D.; Mallick, Avishek
2014-01-01
In a 2-part study, we first examined the results of 71 surveyed physicians who provided responses on how they address the management of patients who maintained either a pacemaker or a defibrillator during radiation treatment. Second, a case review study is presented involving 112 medical records reviewed at 18 institutions to determine whether there was a change in the radiation prescription for the treatment of the target cancer, the method of radiation delivery, or the method of radiation image acquisition. Statistics are provided to illustrate the level of administrative policy; the level of communication between radiation oncologists and heart specialists;more » American Joint Committee on Cancer (AJCC) staging and classification; National Comprehensive Cancer Network (NCCN) guidelines; tumor site; patient's sex; patient's age; device type; manufacturer; live monitoring; and the reported decisions for planning, delivery, and imaging. This survey revealed that 37% of patient treatments were considered for some sort of change in this regard, whereas 59% of patients were treated without regard to these alternatives when available. Only 3% of all patients were identified with an observable change in the functionality of the device or patient status in comparison with 96% of patients with normal behavior and operating devices. Documented changes in the patient's medical record included 1 device exhibiting failure at 0.3-Gy dose, 1 device exhibiting increased sensor rate during dose delivery, 1 patient having an irregular heartbeat leading to device reprogramming, and 1 patient complained of twinging in the chest wall that resulted in a respiratory arrest. Although policies and procedures should directly involve the qualified medical physicist for technical supervision, their sufficient involvement was typically not requested by most respondents. No treatment options were denied to any patient based on AJCC staging, classification, or NCCN practice standards.« less
Applications of remote sensing, volume 3
NASA Technical Reports Server (NTRS)
Landgrebe, D. A. (Principal Investigator)
1977-01-01
The author has identified the following significant results. Of the four change detection techniques (post classification comparison, delta data, spectral/temporal, and layered spectral temporal), the post classification comparison was selected for further development. This was based upon test performances of the four change detection method, straightforwardness of the procedures, and the output products desired. A standardized modified, supervised classification procedure for analyzing the Texas coastal zone data was compiled. This procedure was developed in order that all quadrangles in the study are would be classified using similar analysis techniques to allow for meaningful comparisons and evaluations of the classifications.
DIF Trees: Using Classification Trees to Detect Differential Item Functioning
ERIC Educational Resources Information Center
Vaughn, Brandon K.; Wang, Qiu
2010-01-01
A nonparametric tree classification procedure is used to detect differential item functioning for items that are dichotomously scored. Classification trees are shown to be an alternative procedure to detect differential item functioning other than the use of traditional Mantel-Haenszel and logistic regression analysis. A nonparametric…
18 CFR 3a.13 - Classification responsibility and procedure.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Classification responsibility and procedure. 3a.13 Section 3a.13 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES NATIONAL SECURITY INFORMATION Classification § 3a...
18 CFR 3a.13 - Classification responsibility and procedure.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Classification responsibility and procedure. 3a.13 Section 3a.13 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES NATIONAL SECURITY INFORMATION Classification § 3a...
18 CFR 3a.13 - Classification responsibility and procedure.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Classification responsibility and procedure. 3a.13 Section 3a.13 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES NATIONAL SECURITY INFORMATION Classification § 3a...
18 CFR 3a.13 - Classification responsibility and procedure.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Classification responsibility and procedure. 3a.13 Section 3a.13 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES NATIONAL SECURITY INFORMATION Classification § 3a...
Acquisition and processing of advanced sensor data for ERW and UXO detection and classification
NASA Astrophysics Data System (ADS)
Schultz, Gregory M.; Keranen, Joe; Miller, Jonathan S.; Shubitidze, Fridon
2014-06-01
The remediation of explosive remnants of war (ERW) and associated unexploded ordnance (UXO) has seen improvements through the injection of modern technological advances and streamlined standard operating procedures. However, reliable and cost-effective detection and geophysical mapping of sites contaminated with UXO such as cluster munitions, abandoned ordnance, and improvised explosive devices rely on the ability to discriminate hazardous items from metallic clutter. In addition to anthropogenic clutter, handheld and vehicle-based metal detector systems are plagued by natural geologic and environmental noise in many post conflict areas. We present new and advanced electromagnetic induction (EMI) technologies including man-portable and towed EMI arrays and associated data processing software. While these systems feature vastly different form factors and transmit-receive configurations, they all exhibit several fundamental traits that enable successful classification of EMI anomalies. Specifically, multidirectional sampling of scattered magnetic fields from targets and corresponding high volume of unique data provide rich information for extracting useful classification features for clutter rejection analysis. The quality of classification features depends largely on the extent to which the data resolve unique physics-based parameters. To date, most of the advanced sensors enable high quality inversion by producing data that are extremely rich in spatial content through multi-angle illumination and multi-point reception.
Submerged Object Detection and Classification System
1993-04-16
example of this type of system is a conventional sonar device wherein a highly directional beam of sonic energy periodically radiates from a...scanning transducer which in turn operates as a receiver to detect echoes reflected from any object within the path of 15 propagation. Sonar devices...classification, which requires relatively high frequency signals. Sonar devices also have the shortcoming of sensing background noise generated by
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.
10 CFR 1045.10 - Purpose and scope.
Code of Federal Regulations, 2013 CFR
2013-01-01
... Government-wide policies and procedures concerning the classification and declassification of RD and FRD information. (b) This subpart establishes procedures for classification prohibitions for RD and FRD, describes authorities and procedures for identifying RD and FRD information, and specifies the policies and criteria DOE...
10 CFR 1045.10 - Purpose and scope.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Government-wide policies and procedures concerning the classification and declassification of RD and FRD information. (b) This subpart establishes procedures for classification prohibitions for RD and FRD, describes authorities and procedures for identifying RD and FRD information, and specifies the policies and criteria DOE...
10 CFR 1045.10 - Purpose and scope.
Code of Federal Regulations, 2014 CFR
2014-01-01
... Government-wide policies and procedures concerning the classification and declassification of RD and FRD information. (b) This subpart establishes procedures for classification prohibitions for RD and FRD, describes authorities and procedures for identifying RD and FRD information, and specifies the policies and criteria DOE...
EL68D Wasteway Watershed Land-Cover Generation
Ruhl, Sheila; Usery, E. Lynn; Finn, Michael P.
2007-01-01
Classification of land cover from Landsat Enhanced Thematic Mapper Plus (ETM+) for the EL68D Wasteway Watershed in the State of Washington is documented. The procedures for classification include use of two ETM+ scenes in a simultaneous unsupervised classification process supported by extensive field data collection using Global Positioning System receivers and digital photos. The procedure resulted in a detailed classification at the individual crop species level.
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.
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.
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.
76 FR 80278 - Revision of Cotton Classification Procedures for Determining Cotton Leaf Grade
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-23
...-0066] RIN 0581-AD19 Revision of Cotton Classification Procedures for Determining Cotton Leaf Grade... Pima cotton. The leaf grade is a part of the official classification which denotes cotton fiber quality used in cotton marketing and manufacturing of cotton products. Currently, the leaf grade is determined...
ERIC Educational Resources Information Center
Yang, Xiangdong; Poggio, John C.; Glasnapp, Douglas R.
2006-01-01
The effects of five ability estimators, that is, maximum likelihood estimator, weighted likelihood estimator, maximum a posteriori, expected a posteriori, and Owen's sequential estimator, on the performances of the item response theory-based adaptive classification procedure on multiple categories were studied via simulations. The following…
Specifying Skill-Based Training Strategies and Devices: A Model Description
1990-06-01
Technical Report 897 Specifying Skill-Based Training N Strategies and Devices: A Model Description I Paui J. Sticha and Mark Schlager Human Resources...unlimied 90 ’ Technical Report 897 Specifying Skill-Based Training Strategies and Devices: A Model Description Paul J. Sticha and Mark Schlager Human...SECURITY CLASSIFICATION OF THIS PAGE Form Approved REPORT DOCUMENTATION PAGE FMNo o7 ote la. REPORT SECURITY CLASSIFICATION lb. RESTRICTWE MARKINGS
Refining Landsat classification results using digital terrain data
Miller, Wayne A.; Shasby, Mark
1982-01-01
Scientists at the U.S. Geological Survey's Earth Resources Observation systems (EROS) Data Center have recently completed two land-cover mapping projects in which digital terrain data were used to refine Landsat classification results. Digital ter rain data were incorporated into the Landsat classification process using two different procedures that required developing decision criteria either subjectively or quantitatively. The subjective procedure was used in a vegetation mapping project in Arizona, and the quantitative procedure was used in a forest-fuels mapping project in Montana. By incorporating digital terrain data into the Landsat classification process, more spatially accurate landcover maps were produced for both projects.
Hoffmann, Jürgen; Wallwiener, Diethelm
2009-04-08
One of the basic prerequisites for generating evidence-based data is the availability of classification systems. Attempts to date to classify breast cancer operations have focussed on specific problems, e.g. the avoidance of secondary corrective surgery for surgical defects, rather than taking a generic approach. Starting from an existing, simpler empirical scheme based on the complexity of breast surgical procedures, which was used in-house primarily in operative report-writing, a novel classification of ablative and breast-conserving procedures initially needed to be developed and elaborated systematically. To obtain proof of principle, a prospectively planned analysis of patient records for all major breast cancer-related operations performed at our breast centre in 2005 and 2006 was conducted using the new classification. Data were analysed using basic descriptive statistics such as frequency tables. A novel two-type, six-tier classification system comprising 12 main categories, 13 subcategories and 39 sub-subcategories of oncological, oncoplastic and reconstructive breast cancer-related surgery was successfully developed. Our system permitted unequivocal classification, without exception, of all 1225 procedures performed in 1166 breast cancer patients in 2005 and 2006. Breast cancer-related surgical procedures can be generically classified according to their surgical complexity. Analysis of all major procedures performed at our breast centre during the study period provides proof of principle for this novel classification system. We envisage various applications for this classification, including uses in randomised clinical trials, guideline development, specialist surgical training, continuing professional development as well as quality of care and public health research.
On evaluating clustering procedures for use in classification
NASA Technical Reports Server (NTRS)
Pore, M. D.; Moritz, T. E.; Register, D. T.; Yao, S. S.; Eppler, W. G. (Principal Investigator)
1979-01-01
The problem of evaluating clustering algorithms and their respective computer programs for use in a preprocessing step for classification is addressed. In clustering for classification the probability of correct classification is suggested as the ultimate measure of accuracy on training data. A means of implementing this criterion and a measure of cluster purity are discussed. Examples are given. A procedure for cluster labeling that is based on cluster purity and sample size is presented.
Low-back electromyography (EMG) data-driven load classification for dynamic lifting tasks.
Totah, Deema; Ojeda, Lauro; Johnson, Daniel D; Gates, Deanna; Mower Provost, Emily; Barton, Kira
2018-01-01
Numerous devices have been designed to support the back during lifting tasks. To improve the utility of such devices, this research explores the use of preparatory muscle activity to classify muscle loading and initiate appropriate device activation. The goal of this study was to determine the earliest time window that enabled accurate load classification during a dynamic lifting task. Nine subjects performed thirty symmetrical lifts, split evenly across three weight conditions (no-weight, 10-lbs and 24-lbs), while low-back muscle activity data was collected. Seven descriptive statistics features were extracted from 100 ms windows of data. A multinomial logistic regression (MLR) classifier was trained and tested, employing leave-one subject out cross-validation, to classify lifted load values. Dimensionality reduction was achieved through feature cross-correlation analysis and greedy feedforward selection. The time of full load support by the subject was defined as load-onset. Regions of highest average classification accuracy started at 200 ms before until 200 ms after load-onset with average accuracies ranging from 80% (±10%) to 81% (±7%). The average recall for each class ranged from 69-92%. These inter-subject classification results indicate that preparatory muscle activity can be leveraged to identify the intent to lift a weight up to 100 ms prior to load-onset. The high accuracies shown indicate the potential to utilize intent classification for assistive device applications. Active assistive devices, e.g. exoskeletons, could prevent back injury by off-loading low-back muscles. Early intent classification allows more time for actuators to respond and integrate seamlessly with the user.
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.
A Novel Classification System for Injuries After Electronic Cigarette Explosions.
Patterson, Scott B; Beckett, Allison R; Lintner, Alicia; Leahey, Carly; Greer, Ashley; Brevard, Sidney B; Simmons, Jon D; Kahn, Steven A
Electronic cigarettes (e-cigarettes) contain lithium batteries that have been known to explode and/or cause fires that have resulted in burn injury. The purpose of this article is to present a case study, review injuries caused by e-cigarettes, and present a novel classification system from the newly emerging patterns of burns. A case study was presented and online media reports for e-cigarette burns were queried with search terms "e-cigarette burns" and "electronic cigarette burns." The reports and injury patterns were tabulated. Analysis was then performed to create a novel classification system based on the distinct injury patterns seen in the study. Two patients were seen at our regional burn center after e-cigarette burns. One had an injury to his thigh and penis that required operative intervention after ignition of this device in his pocket. The second had a facial burn and corneal abrasions when the device exploded while he was inhaling vapor. The Internet search and case studies resulted in 26 cases for evaluation. The burn patterns were divided in direct injury from the device igniting and indirect injury when the device caused a house or car fire. A numerical classification was created: direct injury: type 1 (hand injury) 7 cases, type 2 (face injury) 8 cases, type 3 (waist/groin injury) 11 cases, and type 5a (inhalation injury from using device) 2 cases; indirect injury: type 4 (house fire injury) 7 cases and type 5b (inhalation injury from fire started by the device) 4 cases. Multiple e-cigarette injuries are occurring in the United States and distinct patterns of burns are emerging. The classification system developed in this article will aid in further study and future regulation of these dangerous devices.
Doursounian, L; Kilinc, A; Cherrier, B; Nourissat, G
2011-02-01
Despite recent improvements in surgical devices, complex proximal humerus fractures internal fixation still encounters frequent mechanical failures. The aim of this study was to confirm that the Bilboquet device (a design mimicking the cup-and-ball game) helps solving mechanical difficulties associated with these fractures internal fixation and to present a simplified version of the original surgical procedure. This non-randomised prospective study included 22 fractures in 22 patients, mean age: 70 years. According to the Neer classification there were three-part fractures in seven cases and four-part fractures in 15 cases. Fractures were all reduced and treated by internal fixation in a simplified surgical procedure using the Bilboquet device. Mean postoperative follow-up was 34 months. The mean Constant score was 66 and the weighted Constant score was 86. Mean active forward elevation was 108° and mean active external rotation was 28°. No per- or postoperative complications occurred. Initial reduction of the tuberosity was incomplete in four cases. Union was obtained in all fractures. There was no secondary tilting of the head, and no migration or pseudarthrosis of the tuberosities. Five patients developed postoperative avascular necrosis of the humeral head. The Bilboquet staple component provides a supporting platform for the entire humeral head area. This peripheral stabilization associated with tension band wiring explains the lack of secondary displacement in these cases. Although the Bilboquet device provides a solution to the mechanical problems of complex fractures of the proximal humerus, it does not solve the problem of secondary avascular necrosis of the humeral head, which occurred in 23% of the patients in this series and in 33% of patients in the four-part fractures subgroup. IV (non-randomised prospective study). Copyright © 2010 Elsevier Masson SAS. All rights reserved.
43 CFR 2461.1 - Proposed classifications.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Proposed classifications. 2461.1 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.1 Proposed classifications. (a) Proposed classifications will...
43 CFR 2461.4 - Changing classifications.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Changing classifications. 2461.4 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.4 Changing classifications. Classifications may be changed...
43 CFR 2461.1 - Proposed classifications.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Proposed classifications. 2461.1 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.1 Proposed classifications. (a) Proposed classifications will...
43 CFR 2461.4 - Changing classifications.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Changing classifications. 2461.4 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.4 Changing classifications. Classifications may be changed...
43 CFR 2461.1 - Proposed classifications.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Proposed classifications. 2461.1 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.1 Proposed classifications. (a) Proposed classifications will...
43 CFR 2461.4 - Changing classifications.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Changing classifications. 2461.4 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.4 Changing classifications. Classifications may be changed...
43 CFR 2461.1 - Proposed classifications.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Proposed classifications. 2461.1 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.1 Proposed classifications. (a) Proposed classifications will...
43 CFR 2461.4 - Changing classifications.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Changing classifications. 2461.4 Section... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.4 Changing classifications. Classifications may be changed...
Pattern classification using charge transfer devices
NASA Technical Reports Server (NTRS)
1980-01-01
The feasibility of using charge transfer devices in the classification of multispectral imagery was investigated by evaluating particular devices to determine their suitability in matrix multiplication subsystem of a pattern classifier and by designing a protype of such a system. Particular attention was given to analog-analog correlator devices which consist of two tapped delay lines, chip multipliers, and a summed output. The design for the classifier and a printed circuit layout for the analog boards were completed and the boards were fabricated. A test j:g for the board was built and checkout was begun.
Screening and classification of ceramic powders
NASA Technical Reports Server (NTRS)
Miwa, S.
1983-01-01
A summary is given of the classification technology of ceramic powders. Advantages and disadvantages of the wet and dry screening and classification methods are discussed. Improvements of wind force screening devices are described.
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.
21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.
Code of Federal Regulations, 2014 CFR
2014-04-01
... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...
21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.
Code of Federal Regulations, 2012 CFR
2012-04-01
... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...
21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.
Code of Federal Regulations, 2013 CFR
2013-04-01
... SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Surgical Devices § 870.4200... mounting bracket or system-priming equipment. (b) Classification. (1) Class I. The device is classified as...
Contour classification in thermographic images for detection of breast cancer
NASA Astrophysics Data System (ADS)
Okuniewski, Rafał; Nowak, Robert M.; Cichosz, Paweł; Jagodziński, Dariusz; Matysiewicz, Mateusz; Neumann, Łukasz; Oleszkiewicz, Witold
2016-09-01
Thermographic images of breast taken by the Braster device are uploaded into web application which uses different classification algorithms to automatically decide whether a patient should be more thoroughly examined. This article presents the approach to the task of classifying contours visible on thermographic images of breast taken by the Braster device in order to make the decision about the existence of cancerous tumors in breast. It presents the results of the researches conducted on the different classification algorithms.
Certain aspects on medical devices software law regulation.
Pashkov, Vitalii; Harkusha, Andrii
some kind of easiness of entry in creating software products on various computing platforms has led to such products being made available perhaps without due consideration of potential risks to users and patients and the most valuable reason for this have been lack of regulatory clarity. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Guidelines on the qualification and classification of standalone software; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that works in United States of America. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. in accordance with Ukrainian legislation, software that has a medical purpose could be a medical device. Ukrainian legislation which is established on European Union Medical Devices Directives divide all medical devices on classes. But there aren't any special recommendations or advices on classifications for software medical devices in Ukraine. It is necessary to develop and adopt guidelines on the qualification and classification of medical device software in Ukraine especially considering the harmonization of Ukrainian legislation with the EU legislation, develop special rules for the application of the national mark of conformity for medical device software and defined the « responsible organization » for the medical device software approval process.
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...
19 CFR 152.16 - Judicial changes in classification.
Code of Federal Regulations, 2010 CFR
2010-04-01
... OF THE TREASURY (CONTINUED) CLASSIFICATION AND APPRAISEMENT OF MERCHANDISE Classification § 152.16 Judicial changes in classification. The following procedures apply to changes in classification made by... 19 Customs Duties 2 2010-04-01 2010-04-01 false Judicial changes in classification. 152.16 Section...
Smartphone-based fluorescence spectroscopy device aiding in preliminary skin screening
NASA Astrophysics Data System (ADS)
Sahoo, Aparajita; Wahi, Akshat; Das, Anshuman
2018-02-01
Preliminary diagnosis of closely resembling skin conditions can be highly subjective for dermatologists. In ambiguous cases, it often leads to performing invasive procedures like biopsies. Different skin conditions, however, have varying concentrations of fluorophores (like collagen, NADH) and chromophores (like melanin, hemoglobin) which can alter their fluorescence spectra. We demonstrate a handheld, portable, smartphone-based spectrometer that leverages these alterations in skin autofluorescence spectra for rapid screening of skin conditions. This methodology involves excitation of affected skin areas with ultraviolet (UV-A) 385 nm light, capturing the generated fluorescence spectra and sending the data wirelessly to a companion mobile application for data storage, analysis and visualization. By collecting the fluorescence spectral signals from healthy and unhealthy skin conditions, we establish that the signals collected using this portable device can be used to develop a classification method to help in differentially diagnosing these conditions. It shows promise as a useful skin screening tool for both dermatologists and primary health care workers. This device can enable quick, non-invasive and a more objective preliminary examination. We envision the device to be especially useful in primary healthcare centers of developing countries where availability of dermatologists is limited.
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). ...
Low-back electromyography (EMG) data-driven load classification for dynamic lifting tasks
Ojeda, Lauro; Johnson, Daniel D.; Gates, Deanna; Mower Provost, Emily; Barton, Kira
2018-01-01
Objective Numerous devices have been designed to support the back during lifting tasks. To improve the utility of such devices, this research explores the use of preparatory muscle activity to classify muscle loading and initiate appropriate device activation. The goal of this study was to determine the earliest time window that enabled accurate load classification during a dynamic lifting task. Methods Nine subjects performed thirty symmetrical lifts, split evenly across three weight conditions (no-weight, 10-lbs and 24-lbs), while low-back muscle activity data was collected. Seven descriptive statistics features were extracted from 100 ms windows of data. A multinomial logistic regression (MLR) classifier was trained and tested, employing leave-one subject out cross-validation, to classify lifted load values. Dimensionality reduction was achieved through feature cross-correlation analysis and greedy feedforward selection. The time of full load support by the subject was defined as load-onset. Results Regions of highest average classification accuracy started at 200 ms before until 200 ms after load-onset with average accuracies ranging from 80% (±10%) to 81% (±7%). The average recall for each class ranged from 69–92%. Conclusion These inter-subject classification results indicate that preparatory muscle activity can be leveraged to identify the intent to lift a weight up to 100 ms prior to load-onset. The high accuracies shown indicate the potential to utilize intent classification for assistive device applications. Significance Active assistive devices, e.g. exoskeletons, could prevent back injury by off-loading low-back muscles. Early intent classification allows more time for actuators to respond and integrate seamlessly with the user. PMID:29447252
A detailed procedure for the use of small-scale photography in land use classification
NASA Technical Reports Server (NTRS)
Vegas, P. L.
1974-01-01
A procedure developed to produce accurate land use maps from available high-altitude, small-scale photography in a cost-effective manner is presented. An alternative procedure, for use when the capability for updating the resultant land use map is not required, is also presented. The technical approach is discussed in detail, and personnel and equipment needs are analyzed. Accuracy percentages are listed, and costs are cited. The experiment land use classification categories are explained, and a proposed national land use classification system is recommended.
78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-15
... the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v...
Classification of wheat: Badhwar profile similarity technique
NASA Technical Reports Server (NTRS)
Austin, W. W.
1980-01-01
The Badwar profile similarity classification technique used successfully for classification of corn was applied to spring wheat classifications. The software programs and the procedures used to generate full-scene classifications are presented, and numerical results of the acreage estimations are given.
Incineration of different types of medical wastes: emission factors for gaseous emissions
NASA Astrophysics Data System (ADS)
Alvim-Ferraz, M. C. M.; Afonso, S. A. V.
Previous research works showed that to protect public health, the hospital incinerators should be provided with air pollution control devices. As most hospital incinerators do not possess such equipment, efficient methodologies should be developed to evaluate the safety of incineration procedure. Emission factors (EF) can be used for an easy estimation of legal parameters. Nevertheless, the actual knowledge is yet very scarce, mainly because EF previously published do not include enough information about the incinerated waste composition, besides considering many different waste classifications. This paper reports the first EF estimated for CO, SO 2, NO x and HCl, associated to the incineration of medical waste, segregated in different types according to the classification of the Portuguese legislation. The results showed that those EF are strongly influenced by incinerated waste composition, directly affected by incinerated waste type, waste classification, segregation practice and management methodology. The correspondence between different waste classifications was analysed comparing the estimated EF with the sole results previously published for specific waste types, being observed that the correspondence is not always possible. The legal limit for pollutant concentrations could be obeyed for NO x, but concentrations were higher than the limit for CO (11-24 times), SO 2 (2-5 times), and HCl (9-200 times), confirming that air pollution control devices must be used to protect human health. The small heating value of medical wastes with compulsory incineration implied the requirement of a bigger amount of auxiliary fuel for their incineration, which affects the emitted amounts of CO, NO x and SO 2 (28, 20 and practically 100% of the respective values were related with fuel combustion). Nevertheless, the incineration of those wastes lead to the smallest amount of emitted pollutants, the emitted amount of SO 2 and NO x reducing to 93% and the emitted amount of CO and HCl to more than 99%.
Geometry-based ensembles: toward a structural characterization of the classification boundary.
Pujol, Oriol; Masip, David
2009-06-01
This paper introduces a novel binary discriminative learning technique based on the approximation of the nonlinear decision boundary by a piecewise linear smooth additive model. The decision border is geometrically defined by means of the characterizing boundary points-points that belong to the optimal boundary under a certain notion of robustness. Based on these points, a set of locally robust linear classifiers is defined and assembled by means of a Tikhonov regularized optimization procedure in an additive model to create a final lambda-smooth decision rule. As a result, a very simple and robust classifier with a strong geometrical meaning and nonlinear behavior is obtained. The simplicity of the method allows its extension to cope with some of today's machine learning challenges, such as online learning, large-scale learning or parallelization, with linear computational complexity. We validate our approach on the UCI database, comparing with several state-of-the-art classification techniques. Finally, we apply our technique in online and large-scale scenarios and in six real-life computer vision and pattern recognition problems: gender recognition based on face images, intravascular ultrasound tissue classification, speed traffic sign detection, Chagas' disease myocardial damage severity detection, old musical scores clef classification, and action recognition using 3D accelerometer data from a wearable device. The results are promising and this paper opens a line of research that deserves further attention.
ERIC Educational Resources Information Center
Lau, C. Allen; Wang, Tianyou
The purposes of this study were to: (1) extend the sequential probability ratio testing (SPRT) procedure to polytomous item response theory (IRT) models in computerized classification testing (CCT); (2) compare polytomous items with dichotomous items using the SPRT procedure for their accuracy and efficiency; (3) study a direct approach in…
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.
49 CFR 8.19 - Procedures for submitting and processing requests for classification reviews.
Code of Federal Regulations, 2010 CFR
2010-10-01
... classification determination made by another department or agency, the Committee will immediately consult with... for classification reviews. 8.19 Section 8.19 Transportation Office of the Secretary of Transportation CLASSIFIED INFORMATION: CLASSIFICATION/DECLASSIFICATION/ACCESS Classification/Declassification of Information...
Robot-supported assessment of balance in standing and walking.
Shirota, Camila; van Asseldonk, Edwin; Matjačić, Zlatko; Vallery, Heike; Barralon, Pierre; Maggioni, Serena; Buurke, Jaap H; Veneman, Jan F
2017-08-14
Clinically useful and efficient assessment of balance during standing and walking is especially challenging in patients with neurological disorders. However, rehabilitation robots could facilitate assessment procedures and improve their clinical value. We present a short overview of balance assessment in clinical practice and in posturography. Based on this overview, we evaluate the potential use of robotic tools for such assessment. The novelty and assumed main benefits of using robots for assessment are their ability to assess 'severely affected' patients by providing assistance-as-needed, as well as to provide consistent perturbations during standing and walking while measuring the patient's reactions. We provide a classification of robotic devices on three aspects relevant to their potential application for balance assessment: 1) how the device interacts with the body, 2) in what sense the device is mobile, and 3) on what surface the person stands or walks when using the device. As examples, nine types of robotic devices are described, classified and evaluated for their suitability for balance assessment. Two example cases of robotic assessments based on perturbations during walking are presented. We conclude that robotic devices are promising and can become useful and relevant tools for assessment of balance in patients with neurological disorders, both in research and in clinical use. Robotic assessment holds the promise to provide increasingly detailed assessment that allows to individually tailor rehabilitation training, which may eventually improve training effectiveness.
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...
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.
21 CFR 862.1795 - Vanilmandelic acid test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... certain hypertensive conditions. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 862.1335 - Glucagon test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... mellitus, hypoglycemia, and hyperglycemia. (b) Classification. Class I (general controls). The device is...
21 CFR 878.5910 - Pneumatic tourniquet.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...
21 CFR 878.5910 - Pneumatic tourniquet.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...
21 CFR 878.5910 - Pneumatic tourniquet.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...
21 CFR 878.5910 - Pneumatic tourniquet.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...
21 CFR 878.5910 - Pneumatic tourniquet.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Therapeutic Devices § 878.5910 Pneumatic tourniquet... patient's limb and inflated to reduce or totally occlude circulation during surgery. (b) Classification...
43 CFR 2461.2 - Classifications.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Classifications. 2461.2 Section 2461.2..., DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.2 Classifications. Not less than 60 days after publication of the...
43 CFR 2461.2 - Classifications.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Classifications. 2461.2 Section 2461.2..., DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.2 Classifications. Not less than 60 days after publication of the...
43 CFR 2461.2 - Classifications.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Classifications. 2461.2 Section 2461.2..., DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.2 Classifications. Not less than 60 days after publication of the...
43 CFR 2461.2 - Classifications.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Classifications. 2461.2 Section 2461.2..., DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Multiple-Use Classification Procedures § 2461.2 Classifications. Not less than 60 days after publication of the...
21 CFR 862.1490 - Lysozyme (muramidase) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... monocytic leukemia and kidney disease. (b) Classification. Class I (general controls). The device is exempt...
21 CFR 862.1430 - 17-Ketosteroids test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... hypertension, diabetes, and hypothyroidism. (b) Classification. Class I (general controls). The device is...
21 CFR 862.1500 - Malic dehydrogenase test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...
Marx, Ítala; Rodrigues, Nuno; Dias, Luís G; Veloso, Ana C A; Pereira, José A; Drunkler, Deisy A; Peres, António M
2017-01-01
Table olives are highly appreciated and consumed worldwide. Different aspects are used for trade category classification being the sensory assessment of negative defects present in the olives and brines one of the most important. The trade category quality classification must follow the International Olive Council directives, requiring the organoleptic assessment of defects by a trained sensory panel. However, the training process is a hard, complex and sometimes subjective task, being the low number of samples that can be evaluated per day a major drawback considering the real needs of the olive industry. In this context, the development of electronic tongues as taste sensors for defects' sensory evaluation is of utmost relevance. So, an electronic tongue was used for table olives classification according to the presence and intensity of negative defects. Linear discrimination models were established based on sub-sets of sensor signals selected by a simulated annealing algorithm. The predictive potential of the novel approach was first demonstrated for standard solutions of chemical compounds that mimic butyric, putrid and zapateria defects (≥93% for cross-validation procedures). Then its applicability was verified; using reference table olives/brine solutions samples identified with a single intense negative attribute, namely butyric, musty, putrid, zapateria or winey-vinegary defects (≥93% cross-validation procedures). Finally, the E-tongue coupled with the same chemometric approach was applied to classify table olive samples according to the trade commercial categories (extra, 1 st choice, 2 nd choice and unsuitable for consumption) and an additional quality category (extra free of defects), established based on sensory analysis data. Despite the heterogeneity of the samples studied and number of different sensory defects perceived, the predictive linear discriminant model established showed sensitivities greater than 86%. So, the overall performance achieved showed that the electrochemical device could be used as a taste sensor for table olives organoleptic trade successful classification, allowing a preliminary quality assessment, which could facilitate, in the future, the complex task of sensory panelists. Copyright © 2016 Elsevier B.V. All rights reserved.
21 CFR 886.1700 - Pupillometer.
Code of Federal Regulations, 2010 CFR
2010-04-01
... eye. (b) Classification. Class I (general controls). The AC-powered device and the manual device are... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1700 Pupillometer. (a) Identification. A pupillometer is an AC...
43 CFR 2450.4 - Protests: Initial classification decision.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Protests: Initial classification decision... CLASSIFICATION SYSTEM Petition-Application Procedures § 2450.4 Protests: Initial classification decision. (a) For a period of 30 days after the proposed classification decision has been served upon the parties...
NASA Astrophysics Data System (ADS)
Palmieri, Roberta; Bonifazi, Giuseppe; Serranti, Silvia
2014-05-01
The recovery of materials from Demolition Waste (DW) represents one of the main target of the recycling industry and the its characterization is important in order to set up efficient sorting and/or quality control systems. End-Of-Life (EOL) concrete materials identification is necessary to maximize DW conversion into useful secondary raw materials, so it is fundamental to develop strategies for the implementation of an automatic recognition system of the recovered products. In this paper, HyperSpectral Imaging (HSI) technique was applied in order to detect DW composition. Hyperspectral images were acquired by a laboratory device equipped with a HSI sensing device working in the near infrared range (1000-1700 nm): NIR Spectral Camera™, embedding an ImSpector™ N17E (SPECIM Ltd, Finland). Acquired spectral data were analyzed adopting the PLS_Toolbox (Version 7.5, Eigenvector Research, Inc.) under Matlab® environment (Version 7.11.1, The Mathworks, Inc.), applying different chemometric methods: Principal Component Analysis (PCA) for exploratory data approach and Partial Least Square- Discriminant Analysis (PLS-DA) to build classification models. Results showed that it is possible to recognize DW materials, distinguishing recycled aggregates from contaminants (e.g. bricks, gypsum, plastics, wood, foam, etc.). The developed procedure is cheap, fast and non-destructive: it could be used to make some steps of the recycling process more efficient and less expensive.
21 CFR 862.1330 - Globulin test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... other disorders of blood globulins. (b) Classification. Class I (general controls). The device is exempt...
21 CFR 862.1470 - Lipid (total) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...
21 CFR 862.1805 - Vitamin A test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...
21 CFR 862.1610 - Pregnanetriol test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (congenital enlargement of the adrenal gland). (b) Classification. Class I (general controls). The device is...
21 CFR 862.1395 - 17-Hydroxyprogesterone test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... adrenal glands or the ovaries. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 864.2360 - Mycoplasma detection media and components.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY DEVICES Cell And Tissue Culture Products... microbial contaminant in cell cultures. (b) Classification. Class I (general controls). These devices are...
NASA Technical Reports Server (NTRS)
Haralick, R. H. (Principal Investigator); Bosley, R. J.
1974-01-01
The author has identified the following significant results. A procedure was developed to extract cross-band textural features from ERTS MSS imagery. Evolving from a single image texture extraction procedure which uses spatial dependence matrices to measure relative co-occurrence of nearest neighbor grey tones, the cross-band texture procedure uses the distribution of neighboring grey tone N-tuple differences to measure the spatial interrelationships, or co-occurrences, of the grey tone N-tuples present in a texture pattern. In both procedures, texture is characterized in such a way as to be invariant under linear grey tone transformations. However, the cross-band procedure complements the single image procedure by extracting texture information and spectral information contained in ERTS multi-images. Classification experiments show that when used alone, without spectral processing, the cross-band texture procedure extracts more information than the single image texture analysis. Results show an improvement in average correct classification from 86.2% to 88.8% for ERTS image no. 1021-16333 with the cross-band texture procedure. However, when used together with spectral features, the single image texture plus spectral features perform better than the cross-band texture plus spectral features, with an average correct classification of 93.8% and 91.6%, respectively.
Deep learning application: rubbish classification with aid of an android device
NASA Astrophysics Data System (ADS)
Liu, Sijiang; Jiang, Bo; Zhan, Jie
2017-06-01
Deep learning is a very hot topic currently in pattern recognition and artificial intelligence researches. Aiming at the practical problem that people usually don't know correct classifications some rubbish should belong to, based on the powerful image classification ability of the deep learning method, we have designed a prototype system to help users to classify kinds of rubbish. Firstly the CaffeNet Model was adopted for our classification network training on the ImageNet dataset, and the trained network was deployed on a web server. Secondly an android app was developed for users to capture images of unclassified rubbish, upload images to the web server for analyzing backstage and retrieve the feedback, so that users can obtain the classification guide by an android device conveniently. Tests on our prototype system of rubbish classification show that: an image of one single type of rubbish with origin shape can be better used to judge its classification, while an image containing kinds of rubbish or rubbish with changed shape may fail to help users to decide rubbish's classification. However, the system still shows promising auxiliary function for rubbish classification if the network training strategy can be optimized further.
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...
Code of Federal Regulations, 2010 CFR
2010-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General Provisions § 892.1 Scope. (a) This part sets forth the classification of radiology devices... devices, as required by § 807.87. (c) To avoid duplicative listings, a radiology device that has two or...
21 CFR 872.6865 - Powered toothbrush.
Code of Federal Regulations, 2010 CFR
2010-04-01
... remove adherent plaque and food debris from the teeth to reduce tooth decay. (b) Classification. Class I... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6865 Powered toothbrush. (a) Identification. A powered...
21 CFR 862.1325 - Gastrin test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas). (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 882.5870 - Implanted peripheral nerve stimulator for pain relief.
Code of Federal Regulations, 2011 CFR
2011-04-01
... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882... the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class...
Das, Tony; Mustapha, Jihad; Indes, Jeffrey; Vorhies, Robert; Beasley, Robert; Doshi, Nilesh; Adams, George L
2014-01-01
The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA. Methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below-the-knee. Patients (3135) undergoing OA by more than 350 physicians at over 200 US institutions were enrolled on an "all-comers" basis, resulting in registries that provided site-reported patient demographics, ABI, Rutherford classification, co-morbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes. Treatment with OA reduced pre-procedural stenosis from an average of 88-35%. Final residual stenosis after adjunctive treatments, typically low-pressure percutaneous transluminal angioplasty (PTA), averaged 10%. Plaque removal was most effective for severely calcified lesions and least effective for soft plaque. Shorter spin times and smaller crown sizes significantly lowered procedural complications which included slow flow (4.4%), embolism (2.2%), and spasm (6.3%), emphasizing the importance of treatment regimens that focus on plaque modification over maximizing luminal gain. The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, corresponded to a lower incidence of adverse events irrespective of calcium burden or co-morbidities. Copyright © 2013 The Authors. Wiley Periodicals, Inc.
43 CFR 2462.1 - Publication of notice of, and public hearings on, proposed classification.
Code of Federal Regulations, 2011 CFR
2011-10-01
... hearings on, proposed classification. 2462.1 Section 2462.1 Public Lands: Interior Regulations Relating to... (2000) BUREAU INITIATED CLASSIFICATION SYSTEM Disposal Classification Procedure: Over 2,560 Acres § 2462.1 Publication of notice of, and public hearings on, proposed classification. The authorized officer...
43 CFR 2462.2 - Publication of notice of classification.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Publication of notice of classification... CLASSIFICATION SYSTEM Disposal Classification Procedure: Over 2,560 Acres § 2462.2 Publication of notice of classification. After having considered the comments received as the result of publication, the authorized...
Boan, Andrea D; Voeks, Jenifer H; Feng, Wuwei Wayne; Bachman, David L; Jauch, Edward C; Adams, Robert J; Ovbiagele, Bruce; Lackland, Daniel T
2014-01-01
The use of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9) diagnostic codes can identify racial disparities in ischemic stroke hospitalizations; however, inclusion of revascularization procedure codes as acute stroke events may affect the magnitude of the risk difference. This study assesses the impact of excluding revascularization procedure codes in the ICD-9 definition of ischemic stroke, compared with the traditional inclusive definition, on racial disparity estimates for stroke incidence and recurrence. Patients discharged with a diagnosis of ischemic stroke (ICD-9 codes 433.00-434.91 and 436) were identified from a statewide inpatient discharge database from 2010 to 2012. Race-age specific disparity estimates of stroke incidence and recurrence and 1-year cumulative recurrent stroke rates were compared between the routinely used traditional classification and a modified classification of stroke that excluded primary ICD-9 cerebral revascularization procedures codes (38.12, 00.61, and 00.63). The traditional classification identified 7878 stroke hospitalizations, whereas the modified classification resulted in 18% fewer hospitalizations (n = 6444). The age-specific black to white rate ratios were significantly higher in the modified than in the traditional classification for stroke incidence (rate ratio, 1.50; 95% confidence interval [CI], 1.43-1.58 vs. rate ratio, 1.24; 95% CI, 1.18-1.30, respectively). In whites, the 1-year cumulative recurrence rate was significantly reduced by 46% (45-64 years) and 49% (≥ 65 years) in the modified classification, largely explained by a higher rate of cerebral revascularization procedures among whites. There were nonsignificant reductions of 14% (45-64 years) and 19% (≥ 65 years) among blacks. Including cerebral revascularization procedure codes overestimates hospitalization rates for ischemic stroke and significantly underestimates the racial disparity estimates in stroke incidence and recurrence. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.
42 CFR 84.52 - Respiratory hazards; classification.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 1 2012-10-01 2012-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...
42 CFR 84.52 - Respiratory hazards; classification.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 1 2014-10-01 2014-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...
42 CFR 84.52 - Respiratory hazards; classification.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 1 2010-10-01 2010-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...
42 CFR 84.52 - Respiratory hazards; classification.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 42 Public Health 1 2013-10-01 2013-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...
42 CFR 84.52 - Respiratory hazards; classification.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 1 2011-10-01 2011-10-01 false Respiratory hazards; classification. 84.52 Section... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.52 Respiratory...
White, Judith; Carolan-Rees, Grace
2013-01-01
A standardised terminology for describing medical devices can enable safe and unambiguous exchange of information. Proposed changes to EU-wide medical devices regulations mandate the use of such a system. This article reviews two important classification systems for medical devices in the UK. The Global Medical Device Nomenclature (GMDN) provides a classification system specifically for medical devices and diagnostics, and facilitates data exchange between manufacturers and regulators. SNOMED CT is the terminology of choice in the NHS for communicating, sharing and storing information about patients’ healthcare episodes. Harmonisation of GMDN and SNOMED CT will encourage use of single terminology throughout the lifetime of a device; from regulatory approval through clinical use and post-marketing surveillance. Manufacturers will be required to register medical devices with a European device database (Eudamed) and to fit certain devices with a Unique Device Identifier; both are efforts to improve transparency and traceability of medical devices. Successful implementation of these elements depends on having a consistent nomenclature for medical devices. PMID:23885299
21 CFR 862.1615 - Pregnenolone test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... diseases of the adrenal cortex or the gonads. (b) Classification. Class I (general controls). The device is...
21 CFR 878.4700 - Surgical microscope and accessories.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...
21 CFR 878.4700 - Surgical microscope and accessories.
Code of Federal Regulations, 2013 CFR
2013-04-01
... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...
21 CFR 878.4700 - Surgical microscope and accessories.
Code of Federal Regulations, 2011 CFR
2011-04-01
... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...
21 CFR 878.4700 - Surgical microscope and accessories.
Code of Federal Regulations, 2014 CFR
2014-04-01
... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...
21 CFR 878.4700 - Surgical microscope and accessories.
Code of Federal Regulations, 2012 CFR
2012-04-01
... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4700 Surgical... intended for use during surgery to provide a magnified view of the surgical field. (b) Classification...
28 CFR 524.73 - Classification procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... that the affected inmate is notified in writing as promptly as possible of the classification and the...) Central Office Inmate Monitoring Section—reviews classification decisions for all future separation... involving Witness Security cases. (2) Regional Office—reviews CIM classification decisions for Disruptive...
18 CFR 1301.65 - Derivative classification.
Code of Federal Regulations, 2014 CFR
2014-04-01
... classification. 1301.65 Section 1301.65 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES Protection of National Security Classified Information § 1301.65 Derivative classification. (a) In... classified, and the marking of newly developed material consistent with the classification markings that...
18 CFR 1301.65 - Derivative classification.
Code of Federal Regulations, 2013 CFR
2013-04-01
... classification. 1301.65 Section 1301.65 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES Protection of National Security Classified Information § 1301.65 Derivative classification. (a) In... classified, and the marking of newly developed material consistent with the classification markings that...
18 CFR 1301.65 - Derivative classification.
Code of Federal Regulations, 2012 CFR
2012-04-01
... classification. 1301.65 Section 1301.65 Conservation of Power and Water Resources TENNESSEE VALLEY AUTHORITY PROCEDURES Protection of National Security Classified Information § 1301.65 Derivative classification. (a) In... classified, and the marking of newly developed material consistent with the classification markings that...
Anatomic Suitability for Transcaval Access Based on Computed Tomography.
Lederman, Robert J; Greenbaum, Adam B; Rogers, Toby; Khan, Jaffar M; Fusari, Melissa; Chen, Marcus Y
2017-01-09
Transcaval access has been used successfully for over 200 transcatheter aortic valve replacements, large-bore percutaneous left ventricular assist devices, and thoracic endovascular aortic aneurysm repairs. This review teaches how to plan transcaval access and closure based on computed tomography. The main planning goals are to: 1) identify calcium-free crossing targets in the abdominal aorta along with optimal fluoroscopic projection angles and level with respect to lumbar vertebrae; 2) identify obstacles such as interposed bowel or pedunculated aortic atheroma; 3) plan covered stent bailout; and 4) identify jeopardized vascular branches such as renal arteries that might be obstructed by bailout covered stents if employed. The aorta and inferior vena cava are segmented (sculpted) using an image reconstruction workstation and crossing targets are highlighted. Important measurements such as aortic lumen diameter and target distance from renal arteries, aortoiliac bifurcation, and right femoral vein puncture site are reported to assist the operator. The proposed classification for transcaval feasibility has been revised, making some previously unfavorable candidates now feasible or favorable based on procedural success to date. Transcaval access allows percutaneous introduction of large devices into the aorta despite small or diseased iliofemoral arteries. By following these simplified procedures, both operators and imaging specialists can easily prepare comprehensive treatment plans. Copyright © 2017 American College of Cardiology Foundation. All rights reserved.
Sastre, Sergi; Dada, Michelle; Santos, Simon; Lozano, Lluis; Alemany, Xavier; Peidro, Lluis
2015-03-01
The objective of this manuscript is to show an effective, easier and cheaper way to reduce acute acromioclavicular (AC) dislocation type III and V (Rockwood classification). Numerous procedures have been described for surgical management of acromioclavicular joint disruption. Newest devices involve an arthroscopic technique that allows nonrigid anatomic fixation of the acromioclavicular joint. Arthroscopically assisted treatment of acute AC joint dislocation is advantageous because it provides good clinical results and few complications. It also allows reviewing glenohumeral associated lesions. This surgical technique requires no specific implants to achieve a correct AC reduction. Actually, economical advantages are very important factors to decide the use of determinate surgical techniques.
Code of Federal Regulations, 2014 CFR
2014-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...
Code of Federal Regulations, 2011 CFR
2011-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General Provisions § 872.1 Scope. (a) This part sets forth the classification of dental devices intended... devices, as required by § 807.87. (c) To avoid duplicative listings, a dental device that has two or more...
21 CFR 886.1770 - Manual refractor.
Code of Federal Regulations, 2010 CFR
2010-04-01
... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye. (b) Classification. Class I (general controls). The device is exempt from the...
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...
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...
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...
A conceptual weather-type classification procedure for the Philadelphia, Pennsylvania, area
McCabe, Gregory J.
1990-01-01
A simple method of weather-type classification, based on a conceptual model of pressure systems that pass through the Philadelphia, Pennsylvania, area, has been developed. The only inputs required for the procedure are daily mean wind direction and cloud cover, which are used to index the relative position of pressure systems and fronts to Philadelphia.Daily mean wind-direction and cloud-cover data recorded at Philadelphia, Pennsylvania, from January 1954 through August 1988 were used to categorize daily weather conditions. The conceptual weather types reflect changes in daily air and dew-point temperatures, and changes in monthly mean temperature and monthly and annual precipitation. The weather-type classification produced by using the conceptual model was similar to a classification produced by using a multivariate statistical classification procedure. Even though the conceptual weather types are derived from a small amount of data, they appear to account for the variability of daily weather patterns sufficiently to describe distinct weather conditions for use in environmental analyses of weather-sensitive processes.
42 CFR 84.53 - Service time; classification.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 42 Public Health 1 2013-10-01 2013-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...
42 CFR 84.53 - Service time; classification.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 1 2010-10-01 2010-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...
42 CFR 84.53 - Service time; classification.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 42 Public Health 1 2014-10-01 2014-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...
42 CFR 84.53 - Service time; classification.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 1 2011-10-01 2011-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...
42 CFR 84.53 - Service time; classification.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 42 Public Health 1 2012-10-01 2012-10-01 false Service time; classification. 84.53 Section 84.53 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Classification of...
43 CFR 2450.3 - Proposed classification decision.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Proposed classification decision. 2450.3... MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) PETITION-APPLICATION CLASSIFICATION SYSTEM Petition-Application Procedures § 2450.3 Proposed classification decision. (a) The State Director...
10 CFR 110.122 - Classification assistance.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Classification assistance. 110.122 Section 110.122 Energy... Procedures for Classified Information in Hearings § 110.122 Classification assistance. On the request of any... security classification of information and the protective requirements to be observed. ...
10 CFR 110.122 - Classification assistance.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Classification assistance. 110.122 Section 110.122 Energy... Procedures for Classified Information in Hearings § 110.122 Classification assistance. On the request of any... security classification of information and the protective requirements to be observed. ...
10 CFR 110.122 - Classification assistance.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Classification assistance. 110.122 Section 110.122 Energy... Procedures for Classified Information in Hearings § 110.122 Classification assistance. On the request of any... security classification of information and the protective requirements to be observed. ...
10 CFR 110.122 - Classification assistance.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Classification assistance. 110.122 Section 110.122 Energy... Procedures for Classified Information in Hearings § 110.122 Classification assistance. On the request of any... security classification of information and the protective requirements to be observed. ...
10 CFR 110.122 - Classification assistance.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Classification assistance. 110.122 Section 110.122 Energy... Procedures for Classified Information in Hearings § 110.122 Classification assistance. On the request of any... security classification of information and the protective requirements to be observed. ...
21 CFR 872.3765 - Pit and fissure sealant and conditioner.
Code of Federal Regulations, 2012 CFR
2012-04-01
... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3765 Pit and fissure sealant and... depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. (b) Classification...
21 CFR 872.3765 - Pit and fissure sealant and conditioner.
Code of Federal Regulations, 2013 CFR
2013-04-01
... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3765 Pit and fissure sealant and... depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. (b) Classification...
21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...
21 CFR 886.1500 - Headband mirror.
Code of Federal Regulations, 2010 CFR
2010-04-01
... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1500 Headband mirror. (a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. (b) Classification. Class I (general controls). The device is exempt from the...
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...
A Dimensionally Aligned Signal Projection for Classification of Unintended Radiated Emissions
Vann, Jason Michael; Karnowski, Thomas P.; Kerekes, Ryan; ...
2017-04-24
Characterization of unintended radiated emissions (URE) from electronic devices plays an important role in many research areas from electromagnetic interference to nonintrusive load monitoring to information system security. URE can provide insights for applications ranging from load disaggregation and energy efficiency to condition-based maintenance of equipment-based upon detected fault conditions. URE characterization often requires subject matter expertise to tailor transforms and feature extractors for the specific electrical devices of interest. We present a novel approach, named dimensionally aligned signal projection (DASP), for projecting aligned signal characteristics that are inherent to the physical implementation of many commercial electronic devices. These projectionsmore » minimize the need for an intimate understanding of the underlying physical circuitry and significantly reduce the number of features required for signal classification. We present three possible DASP algorithms that leverage frequency harmonics, modulation alignments, and frequency peak spacings, along with a two-dimensional image manipulation method for statistical feature extraction. To demonstrate the ability of DASP to generate relevant features from URE, we measured the conducted URE from 14 residential electronic devices using a 2 MS/s collection system. Furthermore, a linear discriminant analysis classifier was trained using DASP generated features and was blind tested resulting in a greater than 90% classification accuracy for each of the DASP algorithms and an accuracy of 99.1% when DASP features are used in combination. Furthermore, we show that a rank reduced feature set of the combined DASP algorithms provides a 98.9% classification accuracy with only three features and outperforms a set of spectral features in terms of general classification as well as applicability across a broad number of devices.« less
A Dimensionally Aligned Signal Projection for Classification of Unintended Radiated Emissions
DOE Office of Scientific and Technical Information (OSTI.GOV)
Vann, Jason Michael; Karnowski, Thomas P.; Kerekes, Ryan
Characterization of unintended radiated emissions (URE) from electronic devices plays an important role in many research areas from electromagnetic interference to nonintrusive load monitoring to information system security. URE can provide insights for applications ranging from load disaggregation and energy efficiency to condition-based maintenance of equipment-based upon detected fault conditions. URE characterization often requires subject matter expertise to tailor transforms and feature extractors for the specific electrical devices of interest. We present a novel approach, named dimensionally aligned signal projection (DASP), for projecting aligned signal characteristics that are inherent to the physical implementation of many commercial electronic devices. These projectionsmore » minimize the need for an intimate understanding of the underlying physical circuitry and significantly reduce the number of features required for signal classification. We present three possible DASP algorithms that leverage frequency harmonics, modulation alignments, and frequency peak spacings, along with a two-dimensional image manipulation method for statistical feature extraction. To demonstrate the ability of DASP to generate relevant features from URE, we measured the conducted URE from 14 residential electronic devices using a 2 MS/s collection system. Furthermore, a linear discriminant analysis classifier was trained using DASP generated features and was blind tested resulting in a greater than 90% classification accuracy for each of the DASP algorithms and an accuracy of 99.1% when DASP features are used in combination. Furthermore, we show that a rank reduced feature set of the combined DASP algorithms provides a 98.9% classification accuracy with only three features and outperforms a set of spectral features in terms of general classification as well as applicability across a broad number of devices.« less
NASA Astrophysics Data System (ADS)
Sigman, John Brevard
Buried explosive hazards present a pressing problem worldwide. Millions of acres and thousands of sites are contaminated in the United States alone [1, 2]. There are three categories of explosive hazards: metallic, intermediate-electrical conducting (IEC), and non-conducting targets. Metallic target detection and classification by electromagnetic (EM) signature has been the subject of research for many years. Key to the success of this research is modern multi-static Electromagnetic Induction (EMI) sensors, which are able to measure the wideband EMI response from metallic buried targets. However, no hardware solutions exist which can characterize IEC and non-conducting targets. While high-conducting metallic targets exhibit a quadrature peak response for frequencies in a traditional EMI regime under 100 kHz, the response of intermediate-conducting objects manifests at higher frequencies, between 100 kHz and 15 MHz. In addition to high-quality electromagnetic sensor data and robust electromagnetic models, a classification procedure is required to discriminate Targets of Interest (TOI) from clutter. Currently, costly human experts are used for this task. This expense and effort can be spared by using statistical signal processing and machine learning. This thesis has two main parts. In the first part, we explore using the high frequency EMI (HFEMI) band (100 kHz-15 MHz) for detection of carbon fiber UXO, voids, and of materials with characteristics that may be associated with improvised explosive devices (IED). We constructed an HFEMI sensing instrument, and apply the techniques of metal detection to sensing in a band of frequencies which are the transition between the induction and radar bands. In this transition domain, physical considerations and technological issues arise that cannot be solved via the approaches used in either of the bracketing lower and higher frequency ranges. In the second half of this thesis, we present a procedure for automatic classification of UXO. For maximum generality, our algorithm is robust and can handle sparse training examples of multi-class data. This procedure uses an unsupervised starter, semi-supervised techniques to gather training data, and concludes with supervised learning until all TOI are found. Additionally, an inference method for estimating the number of remaining true positives from a partial Receiver Operating Characteristic (ROC) curve is presented and applied to live-site dig histories.
Application and testing of a procedure to evaluate transferability of habitat suitability criteria
Thomas, Jeff A.; Bovee, Ken D.
1993-01-01
A procedure designed to test the transferability of habitat suitability criteria was evaluated in the Cache la Poudre River, Colorado. Habitat suitability criteria were developed for active adult and juvenile rainbow trout in the South Platte River, Colorado. These criteria were tested by comparing microhabitat use predicted from the criteria with observed microhabitat use by adult rainbow trout in the Cache la Poudre River. A one-sided X2 test, using counts of occupied and unoccupied cells in each suitability classification, was used to test for non-random selection for optimum habitat use over usable habitat and for suitable over unsuitable habitat. Criteria for adult rainbow trout were judged to be transferable to the Cache la Poudre River, but juvenile criteria (applied to adults) were not transferable. Random subsampling of occupied and unoccupied cells was conducted to determine the effect of sample size on the reliability of the test procedure. The incidence of type I and type II errors increased rapidly as the sample size was reduced below 55 occupied and 200 unoccupied cells. Recommended modifications to the procedure included the adoption of a systematic or randomized sampling design and direct measurement of microhabitat variables. With these modifications, the procedure is economical, simple and reliable. Use of the procedure as a quality assurance device in routine applications of the instream flow incremental methodology was encouraged.
Code of Federal Regulations, 2011 CFR
2011-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...
Code of Federal Regulations, 2013 CFR
2013-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...
Code of Federal Regulations, 2012 CFR
2012-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...
Code of Federal Regulations, 2014 CFR
2014-04-01
... DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General Provisions § 888.1 Scope. (a) This part sets forth the classification of orthopedic... to other devices, as required by § 807.87. (c) To avoid duplicative listings, an orthopedic device...
21 CFR 886.1760 - Ophthalmic refractometer.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1760 Ophthalmic refractometer. (a) Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system... of the eye by measuring light reflexes from the retina. (b) Classification. Class I (general controls...
Estimating Classification Consistency and Accuracy for Cognitive Diagnostic Assessment
ERIC Educational Resources Information Center
Cui, Ying; Gierl, Mark J.; Chang, Hua-Hua
2012-01-01
This article introduces procedures for the computation and asymptotic statistical inference for classification consistency and accuracy indices specifically designed for cognitive diagnostic assessments. The new classification indices can be used as important indicators of the reliability and validity of classification results produced by…
32 CFR 1648.5 - Procedures during personal appearance before the local board.
Code of Federal Regulations, 2010 CFR
2010-07-01
... SELECTIVE SERVICE SYSTEM CLASSIFICATION BY LOCAL BOARD § 1648.5 Procedures during personal appearance before... classification; direct attention to any information in his file; and present such further information as he... prohibited in proceedings before the board. This does not prevent the registrant or Selective Service from...
26 CFR 301.7701-1 - Classification of organizations for federal tax purposes.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 26 Internal Revenue 18 2010-04-01 2010-04-01 false Classification of organizations for federal tax purposes. 301.7701-1 Section 301.7701-1 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) PROCEDURE AND ADMINISTRATION PROCEDURE AND ADMINISTRATION Definitions § 301.7701-1...
Code of Federal Regulations, 2011 CFR
2011-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL SECURITY CLASSIFICATION REGULATIONS..., safekeeping, accountability, transmission, disposition, and destruction of classification information and... shall conform with the National Security Council Directive of May 17, 1972, governing the classification...
Code of Federal Regulations, 2012 CFR
2012-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL SECURITY CLASSIFICATION REGULATIONS..., safekeeping, accountability, transmission, disposition, and destruction of classification information and... shall conform with the National Security Council Directive of May 17, 1972, governing the classification...
Code of Federal Regulations, 2013 CFR
2013-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL SECURITY CLASSIFICATION REGULATIONS..., safekeeping, accountability, transmission, disposition, and destruction of classification information and... shall conform with the National Security Council Directive of May 17, 1972, governing the classification...
Code of Federal Regulations, 2014 CFR
2014-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL SECURITY CLASSIFICATION REGULATIONS..., safekeeping, accountability, transmission, disposition, and destruction of classification information and... shall conform with the National Security Council Directive of May 17, 1972, governing the classification...
The integration of the risk management process with the lifecycle of medical device software.
Pecoraro, F; Luzi, D
2014-01-01
The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.
21 CFR 864.6160 - Manual blood cell counting device.
Code of Federal Regulations, 2012 CFR
2012-04-01
... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Manual blood cell counting device. 864.6160...
21 CFR 864.6160 - Manual blood cell counting device.
Code of Federal Regulations, 2013 CFR
2013-04-01
... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Manual blood cell counting device. 864.6160...
21 CFR 864.6160 - Manual blood cell counting device.
Code of Federal Regulations, 2011 CFR
2011-04-01
... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Manual blood cell counting device. 864.6160...
21 CFR 864.6160 - Manual blood cell counting device.
Code of Federal Regulations, 2014 CFR
2014-04-01
... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Manual blood cell counting device. 864.6160...
21 CFR 864.6160 - Manual blood cell counting device.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Manual blood cell counting device. 864.6160... blood cell counting device. (a) Identification. A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets. (b) Classification. Class I (general...
Classifier dependent feature preprocessing methods
NASA Astrophysics Data System (ADS)
Rodriguez, Benjamin M., II; Peterson, Gilbert L.
2008-04-01
In mobile applications, computational complexity is an issue that limits sophisticated algorithms from being implemented on these devices. This paper provides an initial solution to applying pattern recognition systems on mobile devices by combining existing preprocessing algorithms for recognition. In pattern recognition systems, it is essential to properly apply feature preprocessing tools prior to training classification models in an attempt to reduce computational complexity and improve the overall classification accuracy. The feature preprocessing tools extended for the mobile environment are feature ranking, feature extraction, data preparation and outlier removal. Most desktop systems today are capable of processing a majority of the available classification algorithms without concern of processing while the same is not true on mobile platforms. As an application of pattern recognition for mobile devices, the recognition system targets the problem of steganalysis, determining if an image contains hidden information. The measure of performance shows that feature preprocessing increases the overall steganalysis classification accuracy by an average of 22%. The methods in this paper are tested on a workstation and a Nokia 6620 (Symbian operating system) camera phone with similar results.
21 CFR 878.4480 - Absorbable powder for lubricating a surgeon's glove.
Code of Federal Regulations, 2010 CFR
2010-04-01
... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878... degradation. (b) Classification. Class III. (c) Date PMA or notice of completion of a PDP is required. As of...
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.
A Model Assessment and Classification System for Men and Women in Correctional Institutions.
ERIC Educational Resources Information Center
Hellervik, Lowell W.; And Others
The report describes a manpower assessment and classification system for criminal offenders directed towards making practical training and job classification decisions. The model is not concerned with custody classifications except as they affect occupational/training possibilities. The model combines traditional procedures of vocational…
de Groot, Ronald; Brekelmans, Pieter; Herremans, Joke; Meulenbelt, Jan
2010-01-01
The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS) is developed to harmonize the criteria for hazard communication worldwide. The European Regulation on classification, labeling, and packaging of substances and mixtures [CLP Regulation (European Commission, EC) No 1272/2008] will align the existing European Union (EU) legislation to the UN-GHS. This CLP Regulation entered into force on January 20, 2009, and will, after a transitional period, replace the current rules on classification, labeling, and packaging for supply and use in Europe. Both old and new classifications will exist simultaneously until 2010 for substances and until 2015 for mixtures. The new hazard classification will introduce new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard (H)-statements, and Precautionary (P)-statements as labeling elements. Furthermore, the CLP Regulation will affect the notification of product information on hazardous products to poisons information centers (PICs). At this moment product notification widely varies in procedures and requirements across EU Member States. Article 45 of the CLP Regulation contains a provision stating that the EC will (by January 20, 2012) review the possibility of harmonizing product notification. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) is recognized as an important stakeholder. For cosmetic products, the new Cosmetics Regulation will directly implement a new procedure for electronic cosmetic product notification in all EU Member States. Both the CLP Regulation and the Cosmetics Regulation will develop their own product notification procedure within different time frames. Harmonization of notification procedures for both product groups, especially a common electronic format, would be most effective from a cost-benefit viewpoint and would be welcomed by PICs.
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. ...
Sousa, Mara E B C; Dias, Luís G; Veloso, Ana C A; Estevinho, Letícia; Peres, António M; Machado, Adélio A S C
2014-10-01
Colour and floral origin are key parameters that may influence the honey market. Monofloral light honey are more demanded by consumers, mainly due to their flavour, being more valuable for producers due to their higher price when compared to darker honey. The latter usually have a high anti-oxidant content that increases their healthy potential. This work showed that it is possible to correctly classify monofloral honey with a high variability in floral origin with a potentiometric electronic tongue after making a preliminary selection of honey according their colours: white, amber and dark honey. The results showed that the device had a very satisfactory sensitivity towards floral origin (Castanea sp., Echium sp., Erica sp., Lavandula sp., Prunus sp. and Rubus sp.), allowing a leave-one-out cross validation correct classification of 100%. Therefore, the E-tongue shows potential to be used at analytical laboratory level for honey samples classification according to market and quality parameters, as a practical tool for ensuring monofloral honey authenticity. Copyright © 2014 Elsevier B.V. All rights reserved.
Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device?
Kramer, A; Conway, B R; Meissner, K; Scholz, F; Rauch, B H; Moroder, A; Ehlers, A; Meixner, A J; Heidecke, C-D; Partecke, L I; Kietzmann, M; Assadian, O
2017-08-02
The use of cold atmospheric pressure plasma (CAPP) as a new therapeutic option to aid the healing of chronic wounds appears promising. Currently, uncertainty exists regarding their classification as medical device or medical drug. Because the classification of CAPP has medical, legal, and economic consequences as well as implications for the level of preclinical and clinical testing, the correct classification is not an academic exercise, but an ethical need. A multidisciplinary team of physicians, surgeons, pharmacists, physicists and lawyers has analysed the physical and technical characteristics as well as legal conditions of the biological action of CAPP. It was concluded that the mode of action of the locally generated CAPP, with its main active components being different radicals, is pharmacological and not physical in nature. Depending on the intended use, CAPP should be classified as a drug, which is generated by use of a medical device directly at the point of therapeutic application.
Classification of parotidectomies: a proposal of the European Salivary Gland Society.
Quer, M; Guntinas-Lichius, O; Marchal, F; Vander Poorten, V; Chevalier, D; León, X; Eisele, D; Dulguerov, P
2016-10-01
The objective of this study is to provide a comprehensive classification system for parotidectomy operations. Data sources include Medline publications, author's experience, and consensus round table at the Third European Salivary Gland Society (ESGS) Meeting. The Medline database was searched with the term "parotidectomy" and "definition". The various definitions of parotidectomy procedures and parotid gland subdivisions extracted. Previous classification systems re-examined and a new classification proposed by a consensus. The ESGS proposes to subdivide the parotid parenchyma in five levels: I (lateral superior), II (lateral inferior), III (deep inferior), IV (deep superior), V (accessory). A new classification is proposed where the type of resection is divided into formal parotidectomy with facial nerve dissection and extracapsular dissection. Parotidectomies are further classified according to the levels removed, as well as the extra-parotid structures ablated. A new classification of parotidectomy procedures is proposed.
21 CFR 878.4010 - Tissue adhesive.
Code of Federal Regulations, 2010 CFR
2010-04-01
..., is a device used for adhesion of internal tissues and vessels. (2) Classification. Class III... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tissue adhesive. 878.4010 Section 878.4010 Food... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue...
21 CFR 878.4010 - Tissue adhesive.
Code of Federal Regulations, 2011 CFR
2011-04-01
..., is a device used for adhesion of internal tissues and vessels. (2) Classification. Class III... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tissue adhesive. 878.4010 Section 878.4010 Food... DEVICES GENERAL AND PLASTIC SURGERY DEVICES Surgical Devices § 878.4010 Tissue adhesive. (a) Tissue...
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.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-15
... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...
Code of Federal Regulations, 2014 CFR
2014-04-01
... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...
Code of Federal Regulations, 2012 CFR
2012-04-01
... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...
Code of Federal Regulations, 2011 CFR
2011-04-01
... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...
Code of Federal Regulations, 2010 CFR
2010-04-01
... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...
Code of Federal Regulations, 2013 CFR
2013-04-01
... MICROBIOLOGY DEVICES General Provisions § 866.1 Scope. (a) This part sets forth the classification of immunology and microbiology devices intended for human use that are in commercial distribution. (b) The... immunology and microbiology device that has two or more types of uses (e.g., used both as a diagnostic device...
Adaptive sleep-wake discrimination for wearable devices.
Karlen, Walter; Floreano, Dario
2011-04-01
Sleep/wake classification systems that rely on physiological signals suffer from intersubject differences that make accurate classification with a single, subject-independent model difficult. To overcome the limitations of intersubject variability, we suggest a novel online adaptation technique that updates the sleep/wake classifier in real time. The objective of the present study was to evaluate the performance of a newly developed adaptive classification algorithm that was embedded on a wearable sleep/wake classification system called SleePic. The algorithm processed ECG and respiratory effort signals for the classification task and applied behavioral measurements (obtained from accelerometer and press-button data) for the automatic adaptation task. When trained as a subject-independent classifier algorithm, the SleePic device was only able to correctly classify 74.94 ± 6.76% of the human-rated sleep/wake data. By using the suggested automatic adaptation method, the mean classification accuracy could be significantly improved to 92.98 ± 3.19%. A subject-independent classifier based on activity data only showed a comparable accuracy of 90.44 ± 3.57%. We demonstrated that subject-independent models used for online sleep-wake classification can successfully be adapted to previously unseen subjects without the intervention of human experts or off-line calibration.
Comparative Analysis of RF Emission Based Fingerprinting Techniques for ZigBee Device Classification
quantify the differences invarious RF fingerprinting techniques via comparative analysis of MDA/ML classification results. The findings herein demonstrate...correct classification rates followed by COR-DNA and then RF-DNA in most test cases and especially in low Eb/N0 ranges, where ZigBee is designed to operate.
Das, Tony; Mustapha, Jihad; Indes, Jeffrey; Vorhies, Robert; Beasley, Robert; Doshi, Nilesh; Adams, George L
2014-01-01
Objectives The purpose of CONFIRM registry series was to evaluate the use of orbital atherectomy (OA) in peripheral lesions of the lower extremities, as well as optimize the technique of OA. Background Methods of treating calcified arteries (historically a strong predictor of treatment failure) have improved significantly over the past decade and now include minimally invasive endovascular treatments, such as OA with unique versatility in modifying calcific lesions above and below-the-knee. Methods Patients (3135) undergoing OA by more than 350 physicians at over 200 US institutions were enrolled on an “all-comers” basis, resulting in registries that provided site-reported patient demographics, ABI, Rutherford classification, co-morbidities, lesion characteristics, plaque morphology, device usage parameters, and procedural outcomes. Results Treatment with OA reduced pre-procedural stenosis from an average of 88–35%. Final residual stenosis after adjunctive treatments, typically low-pressure percutaneous transluminal angioplasty (PTA), averaged 10%. Plaque removal was most effective for severely calcified lesions and least effective for soft plaque. Shorter spin times and smaller crown sizes significantly lowered procedural complications which included slow flow (4.4%), embolism (2.2%), and spasm (6.3%), emphasizing the importance of treatment regimens that focus on plaque modification over maximizing luminal gain. Conclusion The OA technique optimization, which resulted in a change of device usage across the CONFIRM registry series, corresponded to a lower incidence of adverse events irrespective of calcium burden or co-morbidities. © 2013 The Authors. Wiley Periodicals, Inc. PMID:23737432
Chemical action: what is it, and why does it really matter?
NASA Astrophysics Data System (ADS)
Koolage, W. John; Hall, Ralph
2011-04-01
Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration's (FDA) classification structure for "drugs" and "devices." The last major modification to these terms was in 1976, with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by "chemical action." We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies.
21 CFR 862.1505 - Mucopolysaccharides (nonquantitative) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry..., Scheie's Morquio's and Maroteaux-Lamy syndromes. (b) Classification. Class I (general controls). The...
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. ...
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. ...
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. ...
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. ...
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. ...
Code of Federal Regulations, 2014 CFR
2014-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.160 Scope. (a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for...
Code of Federal Regulations, 2013 CFR
2013-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.160 Scope. (a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for...
Code of Federal Regulations, 2012 CFR
2012-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.160 Scope. (a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for...
Code of Federal Regulations, 2011 CFR
2011-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.160 Scope. (a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for...
Code of Federal Regulations, 2010 CFR
2010-07-01
... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152.160 Scope. (a) Types of classification. A pesticide product may be unclassified, or it may be classified for restricted use or for...
Code of Federal Regulations, 2013 CFR
2013-10-01
... the fact that the Commission does not have original classification authority and national security... conjunction with a transfer of functions, to the appropriate federal agency exercising original classification... contractor of the Commission originates information that is believed to require classification, the Executive...
Code of Federal Regulations, 2014 CFR
2014-10-01
... the fact that the Commission does not have original classification authority and national security... conjunction with a transfer of functions, to the appropriate federal agency exercising original classification... contractor of the Commission originates information that is believed to require classification, the Executive...
Code of Federal Regulations, 2012 CFR
2012-10-01
... the fact that the Commission does not have original classification authority and national security... conjunction with a transfer of functions, to the appropriate federal agency exercising original classification... contractor of the Commission originates information that is believed to require classification, the Executive...
Code of Federal Regulations, 2011 CFR
2011-10-01
... classification of U.S. international carriers from dominant to non-dominant. 63.13 Section 63.13... for modifying regulatory classification of U.S. international carriers from dominant to non-dominant... in its application to demonstrate that it qualifies for non-dominant classification pursuant to § 63...
Code of Federal Regulations, 2010 CFR
2010-10-01
... classification of U.S. international carriers from dominant to non-dominant. 63.13 Section 63.13... for modifying regulatory classification of U.S. international carriers from dominant to non-dominant... in its application to demonstrate that it qualifies for non-dominant classification pursuant to § 63...
NASA Technical Reports Server (NTRS)
Card, Don H.; Strong, Laurence L.
1989-01-01
An application of a classification accuracy assessment procedure is described for a vegetation and land cover map prepared by digital image processing of LANDSAT multispectral scanner data. A statistical sampling procedure called Stratified Plurality Sampling was used to assess the accuracy of portions of a map of the Arctic National Wildlife Refuge coastal plain. Results are tabulated as percent correct classification overall as well as per category with associated confidence intervals. Although values of percent correct were disappointingly low for most categories, the study was useful in highlighting sources of classification error and demonstrating shortcomings of the plurality sampling method.
Code of Federal Regulations, 2013 CFR
2013-07-01
... classification as a solid waste, for variances to be classified as a boiler, or for non-waste determinations. 260.33 Section 260.33 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL Rulemaking Petitions § 260.33 Procedures for variances...
Code of Federal Regulations, 2014 CFR
2014-07-01
... classification as a solid waste, for variances to be classified as a boiler, or for non-waste determinations. 260.33 Section 260.33 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL Rulemaking Petitions § 260.33 Procedures for variances...
Code of Federal Regulations, 2012 CFR
2012-07-01
... classification as a solid waste, for variances to be classified as a boiler, or for non-waste determinations. 260.33 Section 260.33 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) HAZARDOUS WASTE MANAGEMENT SYSTEM: GENERAL Rulemaking Petitions § 260.33 Procedures for variances...
ERIC Educational Resources Information Center
Byars, Alvin Gregg
The objectives of this investigation are to develop, describe, assess, and demonstrate procedures for constructing mastery tests to minimize errors of classification and to maximize decision reliability. The guidelines are based on conditions where item exchangeability is a reasonable assumption and the test constructor can control the number of…
Crop Identification Technology Assessment for Remote Sensing (CITARS)
NASA Technical Reports Server (NTRS)
Bauer, M. E.; Cary, T. K.; Davis, B. J.; Swain, P. H.
1975-01-01
The results of classifications and experiments performed for the Crop Identification Technology Assessment for Remote Sensing (CITARS) project are summarized. Fifteen data sets were classified using two analysis procedures. One procedure used class weights while the other assumed equal probabilities of occurrence for all classes. In addition, 20 data sets were classified using training statistics from another segment or date. The results of both the local and non-local classifications in terms of classification and proportion estimation are presented. Several additional experiments are described which were performed to provide additional understanding of the CITARS results. These experiments investigated alternative analysis procedures, training set selection and size, effects of multitemporal registration, the spectral discriminability of corn, soybeans, and other, and analysis of aircraft multispectral data.
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. ...
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. ...
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. ...
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. ...
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. ...
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...
21 CFR 866.4100 - Complement reagent.
Code of Federal Regulations, 2010 CFR
2010-04-01
... DEVICES IMMUNOLOGY AND MICROBIOLOGY DEVICES Immunology Laboratory Equipment and Reagents § 866.4100... a component part of serological test kits used in the diagnosis of disease. (b) Classification...
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. ...
21 CFR 862.3830 - Salicylate test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy. (b) Classification...
Ground Truth Sampling and LANDSAT Accuracy Assessment
NASA Technical Reports Server (NTRS)
Robinson, J. W.; Gunther, F. J.; Campbell, W. J.
1982-01-01
It is noted that the key factor in any accuracy assessment of remote sensing data is the method used for determining the ground truth, independent of the remote sensing data itself. The sampling and accuracy procedures developed for nuclear power plant siting study are described. The purpose of the sampling procedure was to provide data for developing supervised classifications for two study sites and for assessing the accuracy of that and the other procedures used. The purpose of the accuracy assessment was to allow the comparison of the cost and accuracy of various classification procedures as applied to various data types.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Recognition of a Classification Society § 8.200 Purpose. This subpart establishes criteria and procedures for vessel classification societies to obtain recognition from the Coast Guard. This recognition is necessary in order for a classification society to become authorized to perform vessel inspection and...
Code of Federal Regulations, 2011 CFR
2011-10-01
... Recognition of a Classification Society § 8.200 Purpose. This subpart establishes criteria and procedures for vessel classification societies to obtain recognition from the Coast Guard. This recognition is necessary in order for a classification society to become authorized to perform vessel inspection and...
21 CFR 880.6890 - General purpose disinfectants.
Code of Federal Regulations, 2010 CFR
2010-04-01
... prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. (b) Classification. Class I (general controls). The device is exempt...
21 CFR 862.1510 - Nitrite (nonquantitative) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... diagnosis and treatment of uninary tract infection of bacterial origin. (b) Classification. Class I (general...
21 CFR 862.1575 - Phospholipid test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... treatment of disorders involving lipid (fat) metabolism. (b) Classification. Class I (general controls). The...
21 CFR 862.1542 - Oxalate test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... treatment of urinary stones or certain other metabolic disorders. (b) Classification. Class I (general...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-26
...; Hazards caused by electromagnetic interference and electrostatic discharge hazards; and Hearing loss. FDA... electromagnetic Electromagnetic compatibility. interference and electrostatic discharge hazards. Labeling. Hearing...
78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-13
...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...
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...
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...
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...
NASA Astrophysics Data System (ADS)
Pedersen, G. B. M.
2016-02-01
A new object-oriented approach is developed to classify glaciovolcanic landforms (Procedure A) and their landform elements boundaries (Procedure B). It utilizes the principle that glaciovolcanic edifices are geomorphometrically distinct from lava shields and plains (Pedersen and Grosse, 2014), and the approach is tested on data from Reykjanes Peninsula, Iceland. The outlined procedures utilize slope and profile curvature attribute maps (20 m/pixel) and the classified results are evaluated quantitatively through error matrix maps (Procedure A) and visual inspection (Procedure B). In procedure A, the highest obtained accuracy is 94.1%, but even simple mapping procedures provide good results (> 90% accuracy). Successful classification of glaciovolcanic landform element boundaries (Procedure B) is also achieved and this technique has the potential to delineate the transition from intraglacial to subaerial volcanic activity in orthographic view. This object-oriented approach based on geomorphometry overcomes issues with vegetation cover, which has been typically problematic for classification schemes utilizing spectral data. Furthermore, it handles complex edifice outlines well and is easily incorporated into a GIS environment, where results can be edited or fused with other mapping results. The approach outlined here is designed to map glaciovolcanic edifices within the Icelandic neovolcanic zone but may also be applied to similar subaerial or submarine volcanic settings, where steep volcanic edifices are surrounded by flat plains.
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...
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...
21 CFR 868.6175 - Cardiopulmonary emergency cart.
Code of Federal Regulations, 2011 CFR
2011-04-01
... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...
21 CFR 868.6175 - Cardiopulmonary emergency cart.
Code of Federal Regulations, 2010 CFR
2010-04-01
... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...
21 CFR 868.6175 - Cardiopulmonary emergency cart.
Code of Federal Regulations, 2014 CFR
2014-04-01
... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...
21 CFR 868.6175 - Cardiopulmonary emergency cart.
Code of Federal Regulations, 2012 CFR
2012-04-01
... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...
21 CFR 868.6175 - Cardiopulmonary emergency cart.
Code of Federal Regulations, 2013 CFR
2013-04-01
... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...
Segmentation of bone and soft tissue regions in digital radiographic images of extremities
NASA Astrophysics Data System (ADS)
Pakin, S. Kubilay; Gaborski, Roger S.; Barski, Lori L.; Foos, David H.; Parker, Kevin J.
2001-07-01
This paper presents an algorithm for segmentation of computed radiography (CR) images of extremities into bone and soft tissue regions. The algorithm is a region-based one in which the regions are constructed using a growing procedure with two different statistical tests. Following the growing process, tissue classification procedure is employed. The purpose of the classification is to label each region as either bone or soft tissue. This binary classification goal is achieved by using a voting procedure that consists of clustering of regions in each neighborhood system into two classes. The voting procedure provides a crucial compromise between local and global analysis of the image, which is necessary due to strong exposure variations seen on the imaging plate. Also, the existence of regions whose size is large enough such that exposure variations can be observed through them makes it necessary to use overlapping blocks during the classification. After the classification step, resulting bone and soft tissue regions are refined by fitting a 2nd order surface to each tissue, and reevaluating the label of each region according to the distance between the region and surfaces. The performance of the algorithm is tested on a variety of extremity images using manually segmented images as gold standard. The experiments showed that our algorithm provided a bone boundary with an average area overlap of 90% compared to the gold standard.
Technology Readiness Assessment (TRA) Deskbook
2009-07-01
Document CDER Center for Drug Evaluation and Research CDR Critical Design Review CDRH Center for Devices and Radiologic Health CFD computational fluid...gational Device Exemption (IDE) meeting is held with Center for Devices and Radiological Health ( CDRH ) for proposed Class III devices, and the IDE...is prepared and submitted to CDRH . For a 510(k), determine substantially equivalent devices and their classification, validate func- tioning model
George E. Host; Carl W. Ramm; Eunice A. Padley; Kurt S. Pregitzer; James B. Hart; David T. Cleland
1992-01-01
Presents technical documentation for development of an Ecological Classification System for the Manistee National Forest in northwest Lower Michigan, and suggests procedures applicable to other ecological land classification projects. Includes discussion of sampling design, field data collection, data summarization and analyses, development of classification units,...
21 CFR 862.1550 - Urinary pH (nonquantitative) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... the monitoring of patients with certain diets. (b) Classification. Class I (general controls). The...
21 CFR 862.1625 - Prolactin (lactogen) test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... anterior pituitary gland or of the hypothalamus portion of the brain. (b) Classification. Class I (general...
21 CFR 862.1320 - Gastric acidity test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas), and related gastric disorders. (b) Classification. Class I (general...
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. ...
Code of Federal Regulations, 2012 CFR
2012-04-01
... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...
Code of Federal Regulations, 2011 CFR
2011-04-01
... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...
Code of Federal Regulations, 2013 CFR
2013-04-01
... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...
Code of Federal Regulations, 2014 CFR
2014-04-01
... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...
Code of Federal Regulations, 2010 CFR
2010-04-01
... PATHOLOGY DEVICES General Provisions § 864.1 Scope. (a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The...
NASA Astrophysics Data System (ADS)
Fleig, Anne K.; Tallaksen, Lena M.; Hisdal, Hege; Stahl, Kerstin; Hannah, David M.
Classifications of weather and circulation patterns are often applied in research seeking to relate atmospheric state to surface environmental phenomena. However, numerous procedures have been applied to define the patterns, thus limiting comparability between studies. The COST733 Action “ Harmonisation and Applications of Weather Type Classifications for European regions” tests 73 different weather type classifications (WTC) and their associate weather types (WTs) and compares the WTCs’ utility for various applications. The objective of this study is to evaluate the potential of these WTCs for analysis of regional hydrological drought development in north-western Europe. Hydrological drought is defined in terms of a Regional Drought Area Index (RDAI), which is based on deficits derived from daily river flow series. RDAI series (1964-2001) were calculated for four homogeneous regions in Great Britain and two in Denmark. For each region, WTs associated with hydrological drought development were identified based on antecedent and concurrent WT-frequencies for major drought events. The utility of the different WTCs for the study of hydrological drought development was evaluated, and the influence of WTC attributes, i.e. input variables, number of defined WTs and general classification concept, on WTC performance was assessed. The objective Grosswetterlagen (OGWL), the objective Second-Generation Lamb Weather Type Classification (LWT2) with 18 WTs and two implementations of the objective Wetterlagenklassifikation (WLK; with 40 and 28 WTs) outperformed all other WTCs. In general, WTCs with more WTs (⩾27) were found to perform better than WTCs with less (⩽18) WTs. The influence of input variables was not consistent across the different classification procedures, and the performance of a WTC was determined primarily by the classification procedure itself. Overall, classification procedures following the relatively simple general classification concept of predefining WTs based on thresholds, performed better than those based on more sophisticated classification concepts such as deriving WTs by cluster analysis or artificial neural networks. In particular, PCA based WTCs with 9 WTs and automated WTCs with a high number of predefined WTs (subjectively and threshold based) performed well. It is suggested that the explicit consideration of the air flow characteristics of meridionality, zonality and cyclonicity in the definition of WTs is a useful feature for a WTC when analysing regional hydrological drought development.
Analytical Procedures for Testability.
1983-01-01
Beat Internal Classifications", AD: A018516. "A System of Computer Aided Diagnosis with Blood Serum Chemistry Tests and Bayesian Statistics", AD: 786284...6 LIST OF TALS .. 1. Truth Table ......................................... 49 2. Covering Problem .............................. 93 3. Primary and...quential classification procedure in a coronary care ward is evaluated. In the toxicology field "A System of Computer Aided Diagnosis with Blood Serum
Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...
21 CFR 880.5300 - Medical absorbent fiber.
Code of Federal Regulations, 2012 CFR
2012-04-01
...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 880.5300 - Medical absorbent fiber.
Code of Federal Regulations, 2013 CFR
2013-04-01
...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 880.5300 - Medical absorbent fiber.
Code of Federal Regulations, 2014 CFR
2014-04-01
...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...
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...
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...
21 CFR 862.1815 - Vitamin E test system.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... treatment of infants with vitamin E deficiency syndrome. (b) Classification. Class I (general controls). The...
Code of Federal Regulations, 2010 CFR
2010-04-01
... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-23
... Mitigation measures Excessive laser power Electrical safety and electromagnetic compatibility (EMC... should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics; (4...
21 CFR 862.3850 - Sulfonamide 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 sulfonamide levels to ensure appropriate therapy. (b) Classification. Class I. [52 FR 16122, May 1...
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...
Code of Federal Regulations, 2012 CFR
2012-04-01
... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...
Code of Federal Regulations, 2013 CFR
2013-04-01
... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...
Code of Federal Regulations, 2011 CFR
2011-04-01
... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...
Code of Federal Regulations, 2014 CFR
2014-04-01
... CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES General Provisions § 862.1 Scope. (a) This part sets forth the classification of clinical chemistry and clinical toxicology devices intended for human use that are in...
21 CFR 874.4780 - Intranasal splint.
Code of Federal Regulations, 2013 CFR
2013-04-01
... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...
21 CFR 874.4780 - Intranasal splint.
Code of Federal Regulations, 2011 CFR
2011-04-01
... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...
21 CFR 874.4780 - Intranasal splint.
Code of Federal Regulations, 2012 CFR
2012-04-01
... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...
21 CFR 874.4780 - Intranasal splint.
Code of Federal Regulations, 2010 CFR
2010-04-01
... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...
21 CFR 874.4780 - Intranasal splint.
Code of Federal Regulations, 2014 CFR
2014-04-01
... DEVICES EAR, NOSE, AND THROAT DEVICES Surgical Devices § 874.4780 Intranasal splint. (a) Identification... septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material. (b) Classification. Class I (general...
21 CFR 862.2730 - Osmometer for clinical use.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...
21 CFR 862.2730 - Osmometer for clinical use.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...
21 CFR 862.2730 - Osmometer for clinical use.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...
21 CFR 862.2730 - Osmometer for clinical use.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862... to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent... device are used in the diagnosis and treatment of body fluid disorders. (b) Classification. Class I...
21 CFR 892.1400 - Nuclear sealed calibration source.
Code of Federal Regulations, 2012 CFR
2012-04-01
... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...
21 CFR 892.1400 - Nuclear sealed calibration source.
Code of Federal Regulations, 2011 CFR
2011-04-01
... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...
21 CFR 892.1400 - Nuclear sealed calibration source.
Code of Federal Regulations, 2014 CFR
2014-04-01
... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...
21 CFR 892.1400 - Nuclear sealed calibration source.
Code of Federal Regulations, 2010 CFR
2010-04-01
... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...
21 CFR 892.1400 - Nuclear sealed calibration source.
Code of Federal Regulations, 2013 CFR
2013-04-01
... reference radionuclide intended for calibration of medical nuclear radiation detectors. (b) Classification... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nuclear sealed calibration source. 892.1400... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1400 Nuclear sealed calibration source...
NASA Technical Reports Server (NTRS)
Bauer, M. E.; Cary, T. K.; Davis, B. J.; Swain, P. H.
1975-01-01
The results of classifications and experiments for the crop identification technology assessment for remote sensing are summarized. Using two analysis procedures, 15 data sets were classified. One procedure used class weights while the other assumed equal probabilities of occurrence for all classes. Additionally, 20 data sets were classified using training statistics from another segment or date. The classification and proportion estimation results of the local and nonlocal classifications are reported. Data also describe several other experiments to provide additional understanding of the results of the crop identification technology assessment for remote sensing. These experiments investigated alternative analysis procedures, training set selection and size, effects of multitemporal registration, spectral discriminability of corn, soybeans, and other, and analyses of aircraft multispectral data.
NASA Technical Reports Server (NTRS)
Brumfield, J. O.; Bloemer, H. H. L.; Campbell, W. J.
1981-01-01
Two unsupervised classification procedures for analyzing Landsat data used to monitor land reclamation in a surface mining area in east central Ohio are compared for agreement with data collected from the corresponding locations on the ground. One procedure is based on a traditional unsupervised-clustering/maximum-likelihood algorithm sequence that assumes spectral groupings in the Landsat data in n-dimensional space; the other is based on a nontraditional unsupervised-clustering/canonical-transformation/clustering algorithm sequence that not only assumes spectral groupings in n-dimensional space but also includes an additional feature-extraction technique. It is found that the nontraditional procedure provides an appreciable improvement in spectral groupings and apparently increases the level of accuracy in the classification of land cover categories.
NASA Technical Reports Server (NTRS)
Pennington, D. F.; Man, T.; Persons, B.
1977-01-01
The DOT classification for transportation, the military classification for quantity distance, and hazard compatibility grouping used to regulate the transportation and storage of explosives are presented along with a discussion of tests used in determining sensitivity of propellants to an impact/shock environment in the absence of a large explosive donor. The safety procedures and requirements of a Scout launch vehicle, Western and Eastern Test Range, and the Minuteman, Delta, and Poseidon programs are reviewed and summarized. Requirements of the space transportation system safety program include safety reviews from the subsystem level to the completed payload. The Scout safety procedures will satisfy a portion of these requirements but additional procedures need to be implemented to comply with the safety requirements for Shuttle operation from the Eastern Test Range.
Application of GIS-based Procedure on Slopeland Use Classification and Identification
NASA Astrophysics Data System (ADS)
KU, L. C.; LI, M. C.
2016-12-01
In Taiwan, the "Slopeland Conservation and Utilization Act" regulates the management of the slopelands. It categorizes the slopeland into land suitable for agricultural or animal husbandry, land suitable for forestry and land for enhanced conservation, according to the environmental factors of average slope, effective soil depth, soil erosion and parental rock. Traditionally, investigations of environmental factors require cost-effective field works. It has been confronted with many practical issues such as non-evaluated cadastral parcels, evaluation results depending on expert's opinion, difficulties in field measurement and judgment, and time consuming. This study aimed to develop a GIS-based procedure involved in the acceleration of slopeland use classification and quality improvement. First, the environmental factors of slopelands were analyzed by GIS and SPSS software. The analysis involved with the digital elevation model (DEM), soil depth map, land use map and satellite images. Second, 5% of the analyzed slopelands were selected to perform the site investigations and correct the results of classification. Finally, a 2nd examination was involved by randomly selected 2% of the analyzed slopelands to perform the accuracy evaluation. It was showed the developed procedure is effective in slopeland use classification and identification. Keywords: Slopeland Use Classification, GIS, Management
23 CFR 470.105 - Urban area boundaries and highway functional classification.
Code of Federal Regulations, 2010 CFR
2010-04-01
... classification. 470.105 Section 470.105 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION... criteria and procedures are provided in the FHWA publication “Highway Functional Classification—Concepts... functional classification shall be mapped and submitted to the Federal Highway Administration (FHWA) for...
32 CFR 2001.11 - Original classification authority.
Code of Federal Regulations, 2011 CFR
2011-07-01
... classification authority. Agencies not possessing such authority shall forward requests to the Director of ISOO... authority. The Director of ISOO shall forward the request, along with the Director's recommendation, to the... level of original classification authority shall forward requests in accordance with the procedures of...
Belgiu, Mariana; Dr Guţ, Lucian; Strobl, Josef
2014-01-01
The increasing availability of high resolution imagery has triggered the need for automated image analysis techniques, with reduced human intervention and reproducible analysis procedures. The knowledge gained in the past might be of use to achieving this goal, if systematically organized into libraries which would guide the image analysis procedure. In this study we aimed at evaluating the variability of digital classifications carried out by three experts who were all assigned the same interpretation task. Besides the three classifications performed by independent operators, we developed an additional rule-based classification that relied on the image classifications best practices found in the literature, and used it as a surrogate for libraries of object characteristics. The results showed statistically significant differences among all operators who classified the same reference imagery. The classifications carried out by the experts achieved satisfactory results when transferred to another area for extracting the same classes of interest, without modification of the developed rules.
Belgiu, Mariana; Drǎguţ, Lucian; Strobl, Josef
2014-01-01
The increasing availability of high resolution imagery has triggered the need for automated image analysis techniques, with reduced human intervention and reproducible analysis procedures. The knowledge gained in the past might be of use to achieving this goal, if systematically organized into libraries which would guide the image analysis procedure. In this study we aimed at evaluating the variability of digital classifications carried out by three experts who were all assigned the same interpretation task. Besides the three classifications performed by independent operators, we developed an additional rule-based classification that relied on the image classifications best practices found in the literature, and used it as a surrogate for libraries of object characteristics. The results showed statistically significant differences among all operators who classified the same reference imagery. The classifications carried out by the experts achieved satisfactory results when transferred to another area for extracting the same classes of interest, without modification of the developed rules. PMID:24623959
NASA Astrophysics Data System (ADS)
Belgiu, Mariana; ǎguţ, Lucian, , Dr; Strobl, Josef
2014-01-01
The increasing availability of high resolution imagery has triggered the need for automated image analysis techniques, with reduced human intervention and reproducible analysis procedures. The knowledge gained in the past might be of use to achieving this goal, if systematically organized into libraries which would guide the image analysis procedure. In this study we aimed at evaluating the variability of digital classifications carried out by three experts who were all assigned the same interpretation task. Besides the three classifications performed by independent operators, we developed an additional rule-based classification that relied on the image classifications best practices found in the literature, and used it as a surrogate for libraries of object characteristics. The results showed statistically significant differences among all operators who classified the same reference imagery. The classifications carried out by the experts achieved satisfactory results when transferred to another area for extracting the same classes of interest, without modification of the developed rules.
76 FR 47531 - Approval of Classification Societies
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-05
... proposed rulemaking (NPRM) proposing application procedures and performance standards that classification... exempt from Coast Guard approval prior to working in the United States. Because [[Page 47532
78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-08
... MR incompatibility or the conditions for safe use in an MR environment. Labeling will mitigate the... Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and the Food and...) and nonclinical testing evaluating the compatibility of the device in a MR environment. In addition...
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...
New York State Thruway Authority automatic vehicle classification (AVC) : research report.
DOT National Transportation Integrated Search
2008-03-31
In December 2007, the N.Y.S. Thruway Authority (Thruway) concluded a Federal : funded research effort to study technology and develop a design for retrofitting : devices required in implementing a fully automated vehicle classification system i...
Improvement of an algorithm for recognition of liveness using perspiration in fingerprint devices
NASA Astrophysics Data System (ADS)
Parthasaradhi, Sujan T.; Derakhshani, Reza; Hornak, Lawrence A.; Schuckers, Stephanie C.
2004-08-01
Previous work in our laboratory and others have demonstrated that spoof fingers made of a variety of materials including silicon, Play-Doh, clay, and gelatin (gummy finger) can be scanned and verified when compared to a live enrolled finger. Liveness, i.e. to determine whether the introduced biometric is coming from a live source, has been suggested as a means to circumvent attacks using spoof fingers. We developed a new liveness method based on perspiration changes in the fingerprint image. Recent results showed approximately 90% classification rate using different classification methods for various technologies including optical, electro-optical, and capacitive DC, a shorter time window and a diverse dataset. This paper focuses on improvement of the live classification rate by using a weight decay method during the training phase in order to improve the generalization and reduce the variance of the neural network based classifier. The dataset included fingerprint images from 33 live subjects, 33 spoofs created with dental impression material and Play-Doh, and fourteen cadaver fingers. 100% live classification was achieved with 81.8 to 100% spoof classification, depending on the device technology. The weight-decay method improves upon past reports by increasing the live and spoof classification rate.
Differences in forest area classification based on tree tally from variable- and fixed-radius plots
David Azuma; Vicente J. Monleon
2011-01-01
In forest inventory, it is not enough to formulate a definition; it is also necessary to define the "measurement procedure." In the classification of forestland by dominant cover type, the measurement design (the plot) can affect the outcome of the classification. We present results of a simulation study comparing classification of the dominant cover type...
SVM classifier on chip for melanoma detection.
Afifi, Shereen; GholamHosseini, Hamid; Sinha, Roopak
2017-07-01
Support Vector Machine (SVM) is a common classifier used for efficient classification with high accuracy. SVM shows high accuracy for classifying melanoma (skin cancer) clinical images within computer-aided diagnosis systems used by skin cancer specialists to detect melanoma early and save lives. We aim to develop a medical low-cost handheld device that runs a real-time embedded SVM-based diagnosis system for use in primary care for early detection of melanoma. In this paper, an optimized SVM classifier is implemented onto a recent FPGA platform using the latest design methodology to be embedded into the proposed device for realizing online efficient melanoma detection on a single system on chip/device. The hardware implementation results demonstrate a high classification accuracy of 97.9% and a significant acceleration factor of 26 from equivalent software implementation on an embedded processor, with 34% of resources utilization and 2 watts for power consumption. Consequently, the implemented system meets crucial embedded systems constraints of high performance and low cost, resources utilization and power consumption, while achieving high classification accuracy.
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...
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...
Scientific evaluation and pricing of medical devices and associated procedures in France.
Gilard, Martine; Debroucker, Frederique; Dubray, Claude; Allioux, Yves; Aper, Eliane; Barat-Leonhardt, Valérie; Brami, Michèle; Carbonneil, Cédric; Chartier-Kastler, Emmanuel; Coqueblin, Claire; Fare, Sandrine; Giri, Isabelle; Goehrs, Jean-Marie; Levesque, Karine; Maugendre, Philippe; Parquin, François; Sales, Jean-Patrick; Szwarcensztein, Karine
2013-01-01
Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented. © 2013 Société Française de Pharmacologie et de Thérapeutique.
21 CFR 870.2390 - Phonocardiograph.
Code of Federal Regulations, 2010 CFR
2010-04-01
...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 870.2390 - Phonocardiograph.
Code of Federal Regulations, 2011 CFR
2011-04-01
...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 870.2390 - Phonocardiograph.
Code of Federal Regulations, 2013 CFR
2013-04-01
...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 870.2390 - Phonocardiograph.
Code of Federal Regulations, 2014 CFR
2014-04-01
...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 870.2390 - Phonocardiograph.
Code of Federal Regulations, 2012 CFR
2012-04-01
...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...
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...
ERIC Educational Resources Information Center
Chen, Pei-Hua; Chang, Hua-Hua; Wu, Haiyan
2012-01-01
Two sampling-and-classification-based procedures were developed for automated test assembly: the Cell Only and the Cell and Cube methods. A simulation study based on a 540-item bank was conducted to compare the performance of the procedures with the performance of a mixed-integer programming (MIP) method for assembling multiple parallel test…
76 FR 30243 - Minimum Security Devices and Procedures
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Minimum Security Devices and Procedures.... Title of Proposal: Minimum Security Devices and Procedures. OMB Number: 1550-0062. Form Number: N/A. Description: The requirement that savings associations establish a written security program is necessitated by...
A Novel Wearable Device for Food Intake and Physical Activity Recognition
Farooq, Muhammad; Sazonov, Edward
2016-01-01
Presence of speech and motion artifacts has been shown to impact the performance of wearable sensor systems used for automatic detection of food intake. This work presents a novel wearable device which can detect food intake even when the user is physically active and/or talking. The device consists of a piezoelectric strain sensor placed on the temporalis muscle, an accelerometer, and a data acquisition module connected to the temple of eyeglasses. Data from 10 participants was collected while they performed activities including quiet sitting, talking, eating while sitting, eating while walking, and walking. Piezoelectric strain sensor and accelerometer signals were divided into non-overlapping epochs of 3 s; four features were computed for each signal. To differentiate between eating and not eating, as well as between sedentary postures and physical activity, two multiclass classification approaches are presented. The first approach used a single classifier with sensor fusion and the second approach used two-stage classification. The best results were achieved when two separate linear support vector machine (SVM) classifiers were trained for food intake and activity detection, and their results were combined using a decision tree (two-stage classification) to determine the final class. This approach resulted in an average F1-score of 99.85% and area under the curve (AUC) of 0.99 for multiclass classification. With its ability to differentiate between food intake and activity level, this device may potentially be used for tracking both energy intake and energy expenditure. PMID:27409622
A Novel Wearable Device for Food Intake and Physical Activity Recognition.
Farooq, Muhammad; Sazonov, Edward
2016-07-11
Presence of speech and motion artifacts has been shown to impact the performance of wearable sensor systems used for automatic detection of food intake. This work presents a novel wearable device which can detect food intake even when the user is physically active and/or talking. The device consists of a piezoelectric strain sensor placed on the temporalis muscle, an accelerometer, and a data acquisition module connected to the temple of eyeglasses. Data from 10 participants was collected while they performed activities including quiet sitting, talking, eating while sitting, eating while walking, and walking. Piezoelectric strain sensor and accelerometer signals were divided into non-overlapping epochs of 3 s; four features were computed for each signal. To differentiate between eating and not eating, as well as between sedentary postures and physical activity, two multiclass classification approaches are presented. The first approach used a single classifier with sensor fusion and the second approach used two-stage classification. The best results were achieved when two separate linear support vector machine (SVM) classifiers were trained for food intake and activity detection, and their results were combined using a decision tree (two-stage classification) to determine the final class. This approach resulted in an average F1-score of 99.85% and area under the curve (AUC) of 0.99 for multiclass classification. With its ability to differentiate between food intake and activity level, this device may potentially be used for tracking both energy intake and energy expenditure.
Classification of team sport activities using a single wearable tracking device.
Wundersitz, Daniel W T; Josman, Casey; Gupta, Ritu; Netto, Kevin J; Gastin, Paul B; Robertson, Sam
2015-11-26
Wearable tracking devices incorporating accelerometers and gyroscopes are increasingly being used for activity analysis in sports. However, minimal research exists relating to their ability to classify common activities. The purpose of this study was to determine whether data obtained from a single wearable tracking device can be used to classify team sport-related activities. Seventy-six non-elite sporting participants were tested during a simulated team sport circuit (involving stationary, walking, jogging, running, changing direction, counter-movement jumping, jumping for distance and tackling activities) in a laboratory setting. A MinimaxX S4 wearable tracking device was worn below the neck, in-line and dorsal to the first to fifth thoracic vertebrae of the spine, with tri-axial accelerometer and gyroscope data collected at 100Hz. Multiple time domain, frequency domain and custom features were extracted from each sensor using 0.5, 1.0, and 1.5s movement capture durations. Features were further screened using a combination of ANOVA and Lasso methods. Relevant features were used to classify the eight activities performed using the Random Forest (RF), Support Vector Machine (SVM) and Logistic Model Tree (LMT) algorithms. The LMT (79-92% classification accuracy) outperformed RF (32-43%) and SVM algorithms (27-40%), obtaining strongest performance using the full model (accelerometer and gyroscope inputs). Processing time can be reduced through feature selection methods (range 1.5-30.2%), however a trade-off exists between classification accuracy and processing time. Movement capture duration also had little impact on classification accuracy or processing time. In sporting scenarios where wearable tracking devices are employed, it is both possible and feasible to accurately classify team sport-related activities. Copyright © 2015 Elsevier Ltd. All rights reserved.
Classification, disease, and diagnosis.
Jutel, Annemarie
2011-01-01
Classification shapes medicine and guides its practice. Understanding classification must be part of the quest to better understand the social context and implications of diagnosis. Classifications are part of the human work that provides a foundation for the recognition and study of illness: deciding how the vast expanse of nature can be partitioned into meaningful chunks, stabilizing and structuring what is otherwise disordered. This article explores the aims of classification, their embodiment in medical diagnosis, and the historical traditions of medical classification. It provides a brief overview of the aims and principles of classification and their relevance to contemporary medicine. It also demonstrates how classifications operate as social framing devices that enable and disable communication, assert and refute authority, and are important items for sociological study.
21 CFR 874.5550 - Powered nasal irrigator.
Code of Federal Regulations, 2011 CFR
2011-04-01
... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 874.5550 - Powered nasal irrigator.
Code of Federal Regulations, 2012 CFR
2012-04-01
... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 874.5550 - Powered nasal irrigator.
Code of Federal Regulations, 2013 CFR
2013-04-01
... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 874.5550 - Powered nasal irrigator.
Code of Federal Regulations, 2014 CFR
2014-04-01
... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 874.5550 - Powered nasal irrigator.
Code of Federal Regulations, 2010 CFR
2010-04-01
... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...
21 CFR 872.1720 - Pulp tester.
Code of Federal Regulations, 2011 CFR
2011-04-01
... DENTAL DEVICES Diagnostic Devices § 872.1720 Pulp tester. (a) Identification. A pulp tester is an AC or... current transmitted by an electrode to stimulate the nerve tissue in the dental pulp. (b) Classification...
21 CFR 872.1720 - Pulp tester.
Code of Federal Regulations, 2014 CFR
2014-04-01
... DENTAL DEVICES Diagnostic Devices § 872.1720 Pulp tester. (a) Identification. A pulp tester is an AC or... current transmitted by an electrode to stimulate the nerve tissue in the dental pulp. (b) Classification...
21 CFR 884.1550 - Amniotic fluid sampler (amniocentesis tray).
Code of Federal Regulations, 2011 CFR
2011-04-01
... accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks... when used to assess fetal maturity. (b) Classification. Class I (general controls). The device is...
21 CFR 884.1550 - Amniotic fluid sampler (amniocentesis tray).
Code of Federal Regulations, 2010 CFR
2010-04-01
... accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks... when used to assess fetal maturity. (b) Classification. Class I (general controls). The device is...
21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.
Code of Federal Regulations, 2013 CFR
2013-04-01
... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.
Code of Federal Regulations, 2011 CFR
2011-04-01
... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...
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...
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...
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...
Code of Federal Regulations, 2010 CFR
2010-04-01
... to promote evacuation of the contents of the lower colon. The device consists of a container for... irrigation system (§ 876.5220). (b) Classification. Class I (general controls). The device is exempt from the...
21 CFR 886.1800 - Schirmer strip.
Code of Federal Regulations, 2010 CFR
2010-04-01
... device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears. (b) Classification. Class I (general controls). If the device is...
Detecting underwater improvised explosive threats (DUIET)
NASA Astrophysics Data System (ADS)
Feeley, Terry
2010-04-01
Improvised Explosive Devices (IEDs) have presented a major threat in the wars in Afghanistan and Iraq. These devices are powerful homemade land mines that can be small and easily hidden near roadsides. They are then remotely detonated when Coalition Forces pass by either singly or in convoys. Their rapid detection, classification and destruction is key to the safety of troops in the area. These land based bombs will have an analogue in the underwater theater especially in ports, lakes, rivers and streams. These devices may be used against Americans on American soil as an element of the global war on terrorism (GWOT) Rapid detection and classification of underwater improvised explosive devices (UIED) is critical to protecting innocent lives and maintaining the day to day flow of commerce. This paper will discuss a strategy and tool set to deal with this potential threat.
A procedure to detect abnormal sensorimotor control in adolescents with idiopathic scoliosis.
Pialasse, Jean-Philippe; Mercier, Pierre; Descarreaux, Martin; Simoneau, Martin
2017-09-01
This work identifies, among adolescents with idiopathic scoliosis, those demonstrating impaired sensorimotor control through a classification procedure comparing the amplitude of their vestibular-evoked postural responses. The sensorimotor control of healthy adolescents (n=17) and adolescents with idiopathic scoliosis (n=52) with either mild (Cobb angle≥15° and ≤30°) or severe (Cobb angle >30°) spine deformation was assessed through galvanic vestibular stimulation. A classification procedure sorted out adolescents with idiopathic scoliosis whether the amplitude of their vestibular-evoked postural response was dissimilar or similar to controls. Compared to controls, galvanic vestibular stimulation evoked larger postural response in adolescents with idiopathic scoliosis. Nonetheless, the classification procedure revealed that only 42.5% of all patients showed impaired sensorimotor control. Consequently, identifying patients with sensorimotor control impairment would allow to apply personalized treatments, help clinicians to establish prognosis and hopefully improve the condition of patients with adolescent idiopathic scoliosis. Copyright © 2017 Elsevier B.V. All rights reserved.
Online image classification under monotonic decision boundary constraint
NASA Astrophysics Data System (ADS)
Lu, Cheng; Allebach, Jan; Wagner, Jerry; Pitta, Brandi; Larson, David; Guo, Yandong
2015-01-01
Image classification is a prerequisite for copy quality enhancement in all-in-one (AIO) device that comprises a printer and scanner, and which can be used to scan, copy and print. Different processing pipelines are provided in an AIO printer. Each of the processing pipelines is designed specifically for one type of input image to achieve the optimal output image quality. A typical approach to this problem is to apply Support Vector Machine to classify the input image and feed it to its corresponding processing pipeline. The online training SVM can help users to improve the performance of classification as input images accumulate. At the same time, we want to make quick decision on the input image to speed up the classification which means sometimes the AIO device does not need to scan the entire image to make a final decision. These two constraints, online SVM and quick decision, raise questions regarding: 1) what features are suitable for classification; 2) how we should control the decision boundary in online SVM training. This paper will discuss the compatibility of online SVM and quick decision capability.
76 FR 15368 - Minimum Security Devices and Procedures
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-21
... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Minimum Security Devices and Procedures... concerning the following information collection. Title of Proposal: Minimum Security Devices and Procedures... establish a written security program is necessitated by the Bank Protection Act (12 U.S.C. 1881-1884), which...
Code of Federal Regulations, 2010 CFR
2010-04-01
... HOSPITAL AND PERSONAL USE DEVICES General Provisions § 880.1 Scope. (a) This part sets forth the classification of general hospital and personal use devices intended for human use that are in commercial... duplicative listings, a general hospital and personal use device that has two or more types of uses (e.g...
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Dental bur. 872.3240 Section 872.3240 Food and... DENTAL DEVICES Prosthetic Devices § 872.3240 Dental bur. (a) Identification. A dental bur is a rotary... materials intended for use in the fabrication of dental devices. (b) Classification. Class I (general...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Dental bur. 872.3240 Section 872.3240 Food and... DENTAL DEVICES Prosthetic Devices § 872.3240 Dental bur. (a) Identification. A dental bur is a rotary... materials intended for use in the fabrication of dental devices. (b) Classification. Class I (general...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Dental bur. 872.3240 Section 872.3240 Food and... DENTAL DEVICES Prosthetic Devices § 872.3240 Dental bur. (a) Identification. A dental bur is a rotary... materials intended for use in the fabrication of dental devices. (b) Classification. Class I (general...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Dental bur. 872.3240 Section 872.3240 Food and... DENTAL DEVICES Prosthetic Devices § 872.3240 Dental bur. (a) Identification. A dental bur is a rotary... materials intended for use in the fabrication of dental devices. (b) Classification. Class I (general...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Dental bur. 872.3240 Section 872.3240 Food and... DENTAL DEVICES Prosthetic Devices § 872.3240 Dental bur. (a) Identification. A dental bur is a rotary... materials intended for use in the fabrication of dental devices. (b) Classification. Class I (general...
A CRITICAL REVIEW OF A PORTION OF THE LITERATURE ON TEACHING DEVICES.
ERIC Educational Resources Information Center
PORTER, DOUGLAS
A PORTION OF THE LITERATURE CONCERNING MECHANICAL TEACHING MACHINES OR DEVICES, WHICH ALLEGEDLY INCREASE THE EFFICIENCY AND EFFECTIVENESS OF TEACHING OPERATIONS BY MAKING USE OF CERTAIN PSYCHOLOGICAL PRINCIPLES AND TEACHER LABORSAVING FEATURES, IS REVIEWED. A CLASSIFICATION IS MADE OF MECHANICAL TEACHING AIDS AND DEVICES, SUGGESTING THAT THE…
21 CFR 868.5580 - Oxygen mask.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oxygen mask. 868.5580 Section 868.5580 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5580 Oxygen mask. (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (b) Classification...
21 CFR 868.5580 - Oxygen mask.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Oxygen mask. 868.5580 Section 868.5580 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5580 Oxygen mask. (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (b) Classification...
21 CFR 868.5580 - Oxygen mask.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oxygen mask. 868.5580 Section 868.5580 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5580 Oxygen mask. (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (b) Classification...
21 CFR 868.5580 - Oxygen mask.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Oxygen mask. 868.5580 Section 868.5580 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5580 Oxygen mask. (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (b) Classification...
21 CFR 868.5580 - Oxygen mask.
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oxygen mask. 868.5580 Section 868.5580 Food and... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5580 Oxygen mask. (a) Identification. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols. (b) Classification...
16 CFR § 1500.85 - Exemptions from classification as banned hazardous substances.
Code of Federal Regulations, 2013 CFR
2013-01-01
... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...
16 CFR 1500.85 - Exemptions from classification as banned hazardous substances.
Code of Federal Regulations, 2014 CFR
2014-01-01
... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...
16 CFR 1500.85 - Exemptions from classification as banned hazardous substances.
Code of Federal Regulations, 2011 CFR
2011-01-01
... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...
Code of Federal Regulations, 2011 CFR
2011-04-01
... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...
Code of Federal Regulations, 2013 CFR
2013-04-01
... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...
Code of Federal Regulations, 2014 CFR
2014-04-01
... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...
Code of Federal Regulations, 2010 CFR
2010-04-01
... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...
Code of Federal Regulations, 2012 CFR
2012-04-01
... PLASTIC SURGERY DEVICES General Provisions § 878.1 Scope. (a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution. (b) The... listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a...
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...
Code of Federal Regulations, 2010 CFR
2010-04-01
... lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket... intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device...
21 CFR 874.5840 - Antistammering device.
Code of Federal Regulations, 2010 CFR
2010-04-01
... it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...
Marsh, Rachel; Alexander, Gerianne M; Packard, Mark G; Zhu, Hongtu; Peterson, Bradley S
2005-01-01
Procedural learning and memory systems likely comprise several skills that are differentially affected by various illnesses of the central nervous system, suggesting their relative functional independence and reliance on differing neural circuits. Gilles de la Tourette syndrome (GTS) is a movement disorder that involves disturbances in the structure and function of the striatum and related circuitry. Recent studies suggest that patients with GTS are impaired in performance of a probabilistic classification task that putatively involves the acquisition of stimulus-response (S-R)-based habits. Assessing the learning of perceptual-motor skills and probabilistic classification in the same samples of GTS and healthy control subjects may help to determine whether these various forms of procedural (habit) learning rely on the same or differing neuroanatomical substrates and whether those substrates are differentially affected in persons with GTS. Therefore, we assessed perceptual-motor skill learning using the pursuit-rotor and mirror tracing tasks in 50 patients with GTS and 55 control subjects who had previously been compared at learning a task of probabilistic classifications. The GTS subjects did not differ from the control subjects in performance of either the pursuit rotor or mirror-tracing tasks, although they were significantly impaired in the acquisition of a probabilistic classification task. In addition, learning on the perceptual-motor tasks was not correlated with habit learning on the classification task in either the GTS or healthy control subjects. These findings suggest that the differing forms of procedural learning are dissociable both functionally and neuroanatomically. The specific deficits in the probabilistic classification form of habit learning in persons with GTS are likely to be a consequence of disturbances in specific corticostriatal circuits, but not the same circuits that subserve the perceptual-motor form of habit learning.
Detection of wavelengths in the visible range using fiber optic sensors
NASA Astrophysics Data System (ADS)
Díaz, Leonardo; Morales, Yailteh; Mattos, Lorenzo; Torres, Cesar O.
2013-11-01
This paper shows the design and implementation of a fiber optic sensor for detecting and identifying wavelengths in the visible range. The system consists of a diffuse optical fiber, a conventional laser diode 650nm, 2.5mW of power, an ambient light sensor LX1972, a PIC 18F2550 and LCD screen for viewing. The principle used in the detection of the lambda is based on specular reflection and absorption. The optoelectronic device designed and built used the absorption and reflection properties of the material under study, having as active optical medium a bifurcated optical fiber, which is optically coupled to an ambient light sensor, which makes the conversion of light signals to electricas, procedure performed by a microcontroller, which acquires and processes the signal. To verify correct operation of the assembly were utilized the color cards of sewing thread and nail polish as samples for analysis. This optoelectronic device can be used in many applications such as quality control of industrial processes, classification of corks or bottle caps, color quality of textiles, sugar solutions, polymers and food among others.
47 CFR 1.929 - Classification of filings as major or minor.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 47 Telecommunication 1 2011-10-01 2011-10-01 false Classification of filings as major or minor. 1.929 Section 1.929 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE... Classification of filings as major or minor. Applications and amendments to applications for stations in the...
Holzach, P; Matter, P; Minter, J
1994-08-01
A prospective study was performed on 16 patients with lateral tibial plateau fractures. All injuries were associated with alpine or cross-country skiing. Included in the study were those patients with an articular surface depression of > or = 2 mm with radiographic findings consistent with the AO/ASIF classification of tibial plateau fractures (41 B2.2/B3.1). A combined procedure was performed with arthroscopic visualization of the knee joint and utilization of a cannulated plateau elevator. All fractures were reduced with this device with subsequent autogenous bone graft and, when indicated, transverse cancellous lag screw fixation. Follow-up was 1-6.5 years for the 16 patients, with all but two reporting resumption of activity to preinjury levels.
40 CFR 152.166 - Labeling of restricted use products.
Code of Federal Regulations, 2011 CFR
2011-07-01
...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...
40 CFR 152.166 - Labeling of restricted use products.
Code of Federal Regulations, 2013 CFR
2013-07-01
...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...
40 CFR 152.166 - Labeling of restricted use products.
Code of Federal Regulations, 2014 CFR
2014-07-01
...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...
40 CFR 152.166 - Labeling of restricted use products.
Code of Federal Regulations, 2012 CFR
2012-07-01
...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...
40 CFR 152.166 - Labeling of restricted use products.
Code of Federal Regulations, 2010 CFR
2010-07-01
...) PESTICIDE PROGRAMS PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES Classification of Pesticides § 152... formulation into other pesticide products) is not subject to the labeling requirements of this subpart. ...
The influence of multispectral scanner spatial resolution on forest feature classification
NASA Technical Reports Server (NTRS)
Sadowski, F. G.; Malila, W. A.; Sarno, J. E.; Nalepka, R. F.
1977-01-01
Inappropriate spatial resolution and corresponding data processing techniques may be major causes for non-optimal forest classification results frequently achieved from multispectral scanner (MSS) data. Procedures and results of empirical investigations are studied to determine the influence of MSS spatial resolution on the classification of forest features into levels of detail or hierarchies of information that might be appropriate for nationwide forest surveys and detailed in-place inventories. Two somewhat different, but related studies are presented. The first consisted of establishing classification accuracies for several hierarchies of features as spatial resolution was progressively coarsened from (2 meters) squared to (64 meters) squared. The second investigated the capabilities for specialized processing techniques to improve upon the results of conventional processing procedures for both coarse and fine resolution data.
Imitative Robotic Control: The Puppet Master
2014-07-09
puppet style control device and the lessons learned while implementing such a device. 15. SUBJECT TERMS 16. SECURITY CLASSIFICATION OF: 17...mission to be completed in a quick, accurate and efficient manner. This paper outlines the potential features of a puppet style control device and the...lessons learned while implementing such a device. INTRODUCTION As ground robotics moves towards autonomous and semi- autonomous operations, the
NASA Astrophysics Data System (ADS)
Albert, L.; Rottensteiner, F.; Heipke, C.
2015-08-01
Land cover and land use exhibit strong contextual dependencies. We propose a novel approach for the simultaneous classification of land cover and land use, where semantic and spatial context is considered. The image sites for land cover and land use classification form a hierarchy consisting of two layers: a land cover layer and a land use layer. We apply Conditional Random Fields (CRF) at both layers. The layers differ with respect to the image entities corresponding to the nodes, the employed features and the classes to be distinguished. In the land cover layer, the nodes represent super-pixels; in the land use layer, the nodes correspond to objects from a geospatial database. Both CRFs model spatial dependencies between neighbouring image sites. The complex semantic relations between land cover and land use are integrated in the classification process by using contextual features. We propose a new iterative inference procedure for the simultaneous classification of land cover and land use, in which the two classification tasks mutually influence each other. This helps to improve the classification accuracy for certain classes. The main idea of this approach is that semantic context helps to refine the class predictions, which, in turn, leads to more expressive context information. Thus, potentially wrong decisions can be reversed at later stages. The approach is designed for input data based on aerial images. Experiments are carried out on a test site to evaluate the performance of the proposed method. We show the effectiveness of the iterative inference procedure and demonstrate that a smaller size of the super-pixels has a positive influence on the classification result.
Zheng, Haiyong; Wang, Ruchen; Yu, Zhibin; Wang, Nan; Gu, Zhaorui; Zheng, Bing
2017-12-28
Plankton, including phytoplankton and zooplankton, are the main source of food for organisms in the ocean and form the base of marine food chain. As the fundamental components of marine ecosystems, plankton is very sensitive to environment changes, and the study of plankton abundance and distribution is crucial, in order to understand environment changes and protect marine ecosystems. This study was carried out to develop an extensive applicable plankton classification system with high accuracy for the increasing number of various imaging devices. Literature shows that most plankton image classification systems were limited to only one specific imaging device and a relatively narrow taxonomic scope. The real practical system for automatic plankton classification is even non-existent and this study is partly to fill this gap. Inspired by the analysis of literature and development of technology, we focused on the requirements of practical application and proposed an automatic system for plankton image classification combining multiple view features via multiple kernel learning (MKL). For one thing, in order to describe the biomorphic characteristics of plankton more completely and comprehensively, we combined general features with robust features, especially by adding features like Inner-Distance Shape Context for morphological representation. For another, we divided all the features into different types from multiple views and feed them to multiple classifiers instead of only one by combining different kernel matrices computed from different types of features optimally via multiple kernel learning. Moreover, we also applied feature selection method to choose the optimal feature subsets from redundant features for satisfying different datasets from different imaging devices. We implemented our proposed classification system on three different datasets across more than 20 categories from phytoplankton to zooplankton. The experimental results validated that our system outperforms state-of-the-art plankton image classification systems in terms of accuracy and robustness. This study demonstrated automatic plankton image classification system combining multiple view features using multiple kernel learning. The results indicated that multiple view features combined by NLMKL using three kernel functions (linear, polynomial and Gaussian kernel functions) can describe and use information of features better so that achieve a higher classification accuracy.