ASQ Boulder 2024-Mar-28 Section Web Meeting

Topic: AI, ML SaMD De Novo experience, lesson learn
Cost: Free
Note: Thursday 5:45pm to 7:30pm US-MT meeting
RSVP on Boulder Section’s meeting "Meetup Link"
https://www.meetup.com/boulder-quality-meetup/events/297199516/
RSVP note: Please provide your Name and Hometown. Same for any guests
5:45 pm Web Conference Start: Networking, Welcome and Section Business
6:00 pm Presentation

• Speaker: Ed Panek, Blue Spark Technologies
• Topic: AI, ML SaMD De Novo - experience, lesson learn
• Presentation Recording at https://my.asq.org/viewdocument/2024-03meeting-ai-ml-samd-video
  • Voice quality - a little choppy; Slide quality – excellent
  • Sorry for inappropriate interruptions from 1 to 3 minutes mark
• Presentation Slides at https://my.asq.org/viewdocument/2024-03meeting-ai-ml-samd-slides
• Abstract:
  • Ed's introduction to AI/ML
    • Dec 2017 How Google DeepMind AI redefined problem solving in discrete and limited but massive datasets like chess analysis.
    • Early lessons on training models (Machine Learning)
  • FDA and AI/ML
    
    • FDA Trends on AI/ML submissions by modality
    • A learning model or not?
    • Real World Evidence
    • De Novo or 510(k) submission elements
• BIo: Ed Panek is US Navy Veteran and 25 year Quality Professional
  • In the Navy he worked on Radar systems and weapon controls.
  • Ed has established ISO 9001, 17025, and 13485 systems.
  • He has predictive AI experience including 510(k) and De Novo for FDA
  • He is currently work in a small start-up medical devices company
  • He live and work in Cleveland Ohio USA.
• References:
  • Website: Blue Spark Technologies makes TempTraq
  • Website: TempTraq - continuous real-time body temperature monitoring

7:15 pm After Presentation Networking
7:30 pm Web Conference End: meeting over
Place: Web Conference Webex

• Meeting link:  https://asq.webex.com/asq/j.php?MTID=m1df37b471733eb4c9d257b6f5beefa74
• Meeting number: 2556 010 9175
• Password: t6UU9FNVUp5

Meeting also posted on ASQ Boulder Meetup's 28 Mar 2024 meeting