The 2nd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning

Agenda

1. Lectures on Software as a Medical Device Utilizing AI and Machine Learning and Discussion
   • Discussion Points and Issues around Evaluation Data for Diagnostic Support AI
     Fumito NARIYUKI, Senior Manager, IT Solution Div., Medical Systems Business Div., FUJIFILM Corporation (Lecture and  Discussion)
     Jun Masumoto, Divisional Manager, IT group, Medical System Research & Development Center, FUJIFILM Corporation (Discussion)
   • Performance evaluation of post-market re-training of SaMD
     Professor Shimizu (Member of the Subcommittee)
2. Plan in Draft
3. Others

List of Handouts

• Document 1     Summary of Discussions at the 1st Working Group
• Document 2     Lecture Materials by FUJIFILM Corporation
• Document 3     Lecture Materials by Professor Shimizu
• Document 4     Framework of Draft Report