ASQ Boulder 2024-Mar-28 Section Web Meeting

When:  Mar 28, 2024 from 05:45 PM to 07:30 PM (MT)
Associated with  Boulder Section

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"
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
    • Voice quality - a little choppy; Slide quality – excellent
    • Sorry for inappropriate interruptions from 1 to 3 minutes mark
  • Presentation Slides at
  • 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:

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

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


Online Instructions:
Login: Web Conference Webex Meeting link: Meeting number: 2556 010 9175 Password: t6UU9FNVUp5


Arnold Miller