Evaluating imaging and computer-aided detection and diagnosis devices at the FDA.
This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the eva...
| Publicado en: | Academic Radiology Vol. 19; no. 4; pp. 463 - 478 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
Elsevier B.V.
Apr2012
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104540045&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104540045 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10766332 T4X jtl: Academic Radiology issn: 10766332 maglogo: N pubinfo: dt: Apr2012 vid: 19 iid: 4 pid: 467 pub: Elsevier B.V. place: New York, New York artinfo: ui: 104540045 NLM22306064 2011498784 10.1016/j.acra.2011.12.016 NLM22306064 104540045 ppf: 463 ppct: 15 formats: tig: atl: Evaluating imaging and computer-aided detection and diagnosis devices at the FDA. aug: au: Gallas BD Chan HP D'Orsi CJ Dodd LE Giger ML Gur D Krupinski EA Metz CE Myers KJ Obuchowski NA Sahiner B Toledano AY Zuley ML Gallas, Brandon D Chan, Heang-Ping D'Orsi, Carl J Dodd, Lori E Giger, Maryellen L Gur, David Krupinski, Elizabeth A affil: Division of Imaging and Applied Mathematics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993-0002, USA sug: subj: Device Approval Image Interpretation, Computer Assisted Equipment and Supplies Image Interpretation, Computer Assisted Standards Quality Assessment Standards Quality Assessment Trends United States United States Food and Drug Administration ab: This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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