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

Pdf Summary

The document discusses regulations for platform-based "suites of AI technology" in the medical device industry. It provides an overview of device classification and pre-market requirements based on risk levels, outlining the controls and review processes for Class I, Class II, and Class III devices. <br /><br />The focus then shifts to the classification and special controls for gastrointestinal AI/ML products, specifically the Gastrointestinal Lesion Software Detection System (QNP). The document mentions three unique devices cleared under QNP so far and highlights the special controls required for these devices, including clinical and non-clinical performance testing, usability assessment, and labeling requirements.<br /><br />The document also mentions other potential types of AI/ML aids for endoscopy and discusses the need for assessment studies, particularly clinical testing and standalone performance testing. The importance of MRMC (Multiple Reader Multiple Case) studies in generalizing results, statistical analysis plans, and endpoint considerations are emphasized.<br /><br />The standalone performance testing section elaborates on the reference standards, data requirements, and basic endpoints for assessing algorithm performance and generalizability. It mentions frame-based and object-based performance assessment, as well as the need for subgroup analysis.<br /><br />In summary, the document provides an overview of regulations for platform-based AI technology in the medical device industry and highlights the classification and special controls for gastrointestinal AI/ML products. It emphasizes the need for comprehensive assessment studies, including clinical testing and standalone performance testing, in the regulatory review process.

Asset Subtitle

Nicholas Petrick, PhD

Keywords

regulations

platform-based AI technology

medical device industry

device classification

pre-market requirements

gastrointestinal AI/ML products

QNP

clinical testing

standalone performance testing

regulatory review process