Gastroenterology and Artificial Intelligence: 4th Annual Global Artificial Intelligence Summit | August 2022-Regulations for Platform-based “Suites of AI Technology"

Video Transcription

Video Summary

Dr. Nicholas Patrick from the FDA discusses regulations for platform-based suites in AI and technology in this video. He explains that medical devices are categorized into different classes from class 1 to class 3, with regulatory controls increasing from class 1 to class 3. He specifically focuses on class 2 devices such as endoscopes and discusses how these devices can come onto the market through a 510K pre-market notification or a de novo process. He also mentions the importance of data requirements and different aspects of regulatory controls, including general controls, clinical testing, non-clinical testing, usability assessment, electrical safety testing, and labeling. Dr. Patrick also highlights the significance of compatibility between AI devices and different types of equipment. He provides an example of a gastrointestinal lesion software detection system called GI Genius and mentions other categories of AI applications relevant to endoscopy, including computer-aided diagnosis and improving data acquisition. He then explains the study designs and analysis methods used for clinical testing and standalone algorithm performance testing. Dr. Patrick emphasizes the importance of clinician variability, matching patient populations, and accounting for correlations in data analysis. He concludes by summarizing the key points discussed in the video.

Asset Subtitle

Nicholas Petrick, PhD

Keywords

FDA regulations

platform-based suites

medical devices

regulatory controls

AI devices