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Activity Number:
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500
- Beyond Randomized Studies: Nonrandomized, Single Arm, or Special Studies
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 2, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #322969
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View Presentation
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Title:
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Why Not Consensus Reading with Multiple Readers for Evaluating a New (Test) Device?
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Author(s):
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Bipasa Biswas*
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Companies:
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CDRH, FDA
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Keywords:
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correlated binary data ;
sensitivity ;
specificity ;
bias
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Abstract:
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Diagnostic devices, like imaging devices, often require an interface of a reader evaluation and interpretation to provide a final diagnosis. The diagnosis is a qualitative assessment and thus the reader's responses are yes/no or present/absent. Examples include pill-cameras that image the colon to detect polyps. This presentation will discuss why a consensus reading of the subject device under evaluation, is not appropriate, when in practice only a single reader is involved in evaluating the images. Simulations using correlated binary data will be presented to show that the results using consensus readings are biased optimistically.
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Authors who are presenting talks have a * after their name.
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