Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA

Brandon D. Gallas; Heang Ping Chan; Carl J. D'Orsi; Lori E. Dodd; Maryellen L. Giger; David Gur; Elizabeth A. Krupinski; Charles E. Metz; Kyle J. Myers; Nancy A. Obuchowski; Berkman Sahiner; Alicia Y. Toledano; Margarita L. Zuley

doi:10.1016/j.acra.2011.12.016

Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA

Brandon D. Gallas, Heang Ping Chan, Carl J. D'Orsi, Lori E. Dodd, Maryellen L. Giger, David Gur, Elizabeth A. Krupinski, Charles E. Metz, Kyle J. Myers, Nancy A. Obuchowski, Berkman Sahiner, Alicia Y. Toledano, Margarita L. Zuley

Medical Imaging

Research output: Contribution to journal › Review article › peer-review

65 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	463-477
Number of pages	15
Journal	Academic radiology
Volume	19
Issue number	4
DOIs	https://doi.org/10.1016/j.acra.2011.12.016
State	Published - Apr 2012

Keywords

Consensus
Designs
Methods
Postmarket
Premarket
ROC
Reader studies

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging

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10.1016/j.acra.2011.12.016

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title = "Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA",

abstract = "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.",

keywords = "Consensus, Designs, Methods, Postmarket, Premarket, ROC, Reader studies",

author = "Gallas, {Brandon D.} and Chan, {Heang Ping} and D'Orsi, {Carl J.} and Dodd, {Lori E.} and Giger, {Maryellen L.} and David Gur and Krupinski, {Elizabeth A.} and Metz, {Charles E.} and Myers, {Kyle J.} and Obuchowski, {Nancy A.} and Berkman Sahiner and Toledano, {Alicia Y.} and Zuley, {Margarita L.}",

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doi = "10.1016/j.acra.2011.12.016",

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AU - Giger, Maryellen L.

AU - Gur, David

AU - Krupinski, Elizabeth A.

AU - Metz, Charles E.

AU - Myers, Kyle J.

AU - Obuchowski, Nancy A.

AU - Sahiner, Berkman

AU - Toledano, Alicia Y.

AU - Zuley, Margarita L.

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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.

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KW - Designs

KW - Methods

KW - Postmarket

KW - Premarket

KW - ROC

KW - Reader studies

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Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA

Abstract

Keywords

ASJC Scopus subject areas

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