Evaluating Imaging and Computer-aided Detection and Diagnosis Devices at the FDA
Open accessAbstract
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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By ensuring each reader reviewed each case only once in either the assisted or unassisted modality, the design eliminated any memory effect associated with a crossover study.
“By ensuring each reader reviewed each case only once in either the assisted or unassisted modality, this design eliminated any memory effect associated with a crossover study (where memorable cases may inflate the diagnostic performance when reviewed a second time by the same readers).28,29”
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- Authors
- Gallas, B. D., Chan, H.-P., D’Orsi, C. J., Dodd, L. E., Giger, M. L., Gur, D., Krupinski, E. A., Metz, C. E., Myers, K. J., Obuchowski, N. A., Sahiner, B., Toledano, A. Y., & Zuley, M. L.
- Affiliations
- United States Food and Drug Administration (US)
- University of Michigan (US)
- Emory University (US)
- National Institutes of Health (US)
- University of Chicago (US)
- University of Pittsburgh (US)
- University of Arizona (US)
- Cleveland Clinic (US)
- Statistics Collaborative (US)
- Corresponding author
- Gallas, Brandon D.
- ORCID
- Venue
- Academic Radiology
- Publisher
- Elsevier BV
- Published
- 2012-04
- Volume
- 19
- Issue
- 4
- Pages
- 463-477
- ISSN
- 1076-6332 (ISSN-L)
- PMC
- PMC5557046
- OpenAlex
- W2122441470
- Cited by
- 81
- References
- 0
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 8 · 2023: 8 · 2022: 8 · 2021: 8 · 2020: 6 · 2019: 4 · 2018: 7 · 2017: 5 · 2016: 2 · 2015: 3 · 2014: 7 · 2013: 3 · 2012: 3
- FWCI
- 4.33
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Academic Radiology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (FD999999)
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiology practices and education
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
- Keywords
- computer-aided detection, computer-aided diagnosis, medical imaging equipment, device evaluation, FDA regulatory submissions, statistical analysis, research design, consensus development
- MeSH terms
- Image Interpretation, Computer-Assisted, Technology Assessment, Biomedical, United States, United States Food and Drug Administration, Device Approval
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