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Activity Details
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378 *
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Thu, 8/12/2021,
12:00 PM -
1:50 PM
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Virtual
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Study Design and Statistical Challenges for AI/ML Based Medical Tests — Topic-Contributed Papers
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Section on Medical Devices and Diagnostics, Biopharmaceutical Section
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Organizer(s): Rajesh R Nair, CDRH/FDA
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Chair(s): Sung Hee Kim, CDRH/FDA
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12:05 PM
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Statistical Challenges in the Design and Validation of Medical Deep Learning Models
Andrew Beam, Harvard
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12:25 PM
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Validation of a Breakthrough AI-Guided Echocardiography System: Overcoming Challenges in Testing AI-Based Medical Device
Ha Hong, Caption Health, Inc.; Samuel Surette, Caption Health, Inc.; Yngvil Thomas, Caption Health, Inc.; Charles Cadieu, Caption Health, Inc.; Ali Chaudhry, Caption Health, Inc.; Randolph Martin, Caption Health, Inc.
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12:45 PM
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AI/ML Application and Challenges in Medical Diagnostic Tests
Bipasa Biswas, FDA
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1:05 PM
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DADP: Dynamic Abnormality Detection and Progression for Longitudinal Knee Magnetic Resonance Images from the Osteoarthritis Initiative
Chao Huang, Florida State University
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1:25 PM
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Statistical Consideration in Demonstrating Standalone Performance for AI/ML-Based Computer-Aided Detection Devices
Jessie Moon, FDA
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1:45 PM
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Floor Discussion
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