Agenda
Radiological
Devices Panel Meeting
February
3, 2004
Purpose of the Meeting - To discuss, make recommendations and
vote on a premarket approval application (PMA P030012) for a computer aided
detection device that assists a physician in identifying solid nodules in CT
images of the lung.
Closed Session
8:30 – 8:35 Call
to order– Minesh P. Mehta, M.D.
8:35
– 9:00 Briefing on Current Investigational Devices - Robert A.
Phillips, Ph.D. and RADB Staff
Open Session
9:00
– 9:20 Call to order and the Panel Introduction – Minesh P.
Mehta, M.D.
FDA Introductory Remarks - Robert J. Doyle, Executive
Secretary
Update on FDA Radiology Activities - Robert A. Phillips,
Ph.D.
Open Public Hearing
9:20
– 9:50 Open Public Hearing: interested persons may present data,
information, or views, orally or in writing, on issues pending before the
committee.
Open Committee Discussion
9:50
– 10:00 Charge to the Panel - Minesh P. Mehta, M.D.
10:00
– 10:40 Overview
of Contemporary ROC Methods – Robert F. Wagner, Ph.D.
10:45
– 11:45 Presentations
on P030012 by sponsor
Introduction – Kathy
O’Shaughnessy, PhD
Current Clinical
Practice – Heber MacMahon, MD
Device Description and Clinical Trial
Introduction – Ronald Castellino, MD
Clinical Study – Dave
Miller
User Experience –
Pablo Delgado, MD
Summary – Kathy
O’Shaughnessy, PhD
11:45
- 12:45 Lunch
12:45
– 1:45 Presentations
on P030012 by FDA
- Clinical
Background - William Sacks, Ph.D., M.D
- Clinical
Results - Nicholas Petrick, Ph.D.
- PMA Review Summary
- William Sacks, Ph.D., M.D
1:45
– 2:15 Reports by Panel Lead Reviewers
- David Stark, M.D.
-
Brent Blumenstein, Ph.D.
2:15
– 2:30 Presentation of FDA Questions
2:30 – 2:45 Break
2:45 – 3:45 Panel
Discussion
Open Public Hearing
3:45
– 4:15 Open Public Hearing: interested persons may present data,
information, or views, orally or in writing, on issues pending before the
committee.
Open Committee Deliberations
4:15 – 4:30 Panel
Recommendation(s) and vote
4:30 Adjourn