Diagnostic AI Testing Best Practices for Regulatory Submissions

Upcoming Virtual Courses

Expert Insights

Diagnostic AI Testing Best Practices for Regulatory Submissions (Nov 2024)

Nov 18 to Nov 18, 2024

Overview

This course explores testing strategies and study design considerations for diagnostic AI models requiring premarket clearance by regulatory bodies like the USA FDA, EU MDR, and those adhering to ISO 13485 standards. Focusing on detection AI, the training covers bench and clinical testing, emphasizing their roles in bias mitigation, clinical effectiveness, and regulatory compliance.

Key topics include the purpose of bench testing for performance assessment and design changes, and clinical testing (reader studies) for clinical effectiveness. The course also covers test scope, MRMC study design, acceptance criteria, statistical techniques such as AFROC, sensitivity, specificity, sample size rationales, and bias controls. Additionally, it provides an overview of regulatory guidance, including AAMI 34971 and FDA Good Machine Learning Practices, stressing the importance of early test protocol development in the design and submission process.

Objectives

Over the course of four (4) hours, the attendee/participant will be able to:

  • Develop a diagnostic AI V&V test protocol and begin the outline of their own test protocol from their jobs from the case study portion of the training.
  • Apply regulatory requirements and considerations in their test protocol.
  • Understand the study design and statistical techniques used in these protocols.

Who Should Attend?

Medical Device Manufacturing professionals in the Quality, Regulatory, AI/ML Engineering, Clinical and Statistics departments

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Faculty

Adam Foresman

Director of Quality & Regulatory VideaHealth