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378 * Thu, 8/12/2021, 12:00 PM - 1:50 PM Virtual
Study Design and Statistical Challenges for AI/ML Based Medical Tests — Topic-Contributed Papers
Section on Medical Devices and Diagnostics, Biopharmaceutical Section
Organizer(s): Rajesh R Nair, CDRH/FDA
Chair(s): Sung Hee Kim, CDRH/FDA
12:05 PM Statistical Challenges in the Design and Validation of Medical Deep Learning Models
Andrew Beam, Harvard
12:25 PM 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.
12:45 PM AI/ML Application and Challenges in Medical Diagnostic Tests
Bipasa Biswas, FDA
1:05 PM DADP: Dynamic Abnormality Detection and Progression for Longitudinal Knee Magnetic Resonance Images from the Osteoarthritis Initiative
Chao Huang, Florida State University
1:25 PM Statistical Consideration in Demonstrating Standalone Performance for AI/ML-Based Computer-Aided Detection Devices 
Jessie Moon, FDA
1:45 PM Floor Discussion