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
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 Slides and Video posted after meeting
• Abstract:
  -- Ed's introduction to AI
  --- Dec 2017 How Google DeepMind AI redefined problem solving in discrete and limited but massive datasets like chess analysis.
  --- Early lessons on training models
  -- FDA and AI
  --- FDA Trends on AI 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 MyASQ Boulder Community Event