The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning

Agenda

1. Study on Issue of Report
   • Way of Reuse of Data
   • Terms Required for Data Assessment
   • Way of Examination of Adaptive AI
2. Others

List of Handouts

• Document 1     Summary of Discussions at the 3rd Working Group
• Document 2     Script of Post-market Change of Performance
• Document 3     Topic Note of Discussion (January 23,2023)
• Document 4     Modality-specific Situation of Database
• Document 5     Agenda and Draft of Report (Repost of the 3rd Subcommittee)