SystemAIS-002Medical device and SaMD
Triage Note Summariser
Summarise free-text triage notes for the reviewing nurse. Non-diagnostic.
Device class
Not a medical device
- Status
- In development
- State
- In progress
- Owner
- Cirocco Jones
- Record completeness
- 72
100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.
- Blockers
- 2
Monitoring does not stop when an AI System is approved. A signal opens a finding, and a breach can place the AI System under restriction before anyone opens a form.
Scout is watching
Nothing open. Every signal raised has been acknowledged and answered.
Open signals
Most severe first. Nothing closes itself.
| Observed | Type | Signal | Severity |
|---|
No open signals.
Answered
Kept, because the response is part of the record. An acknowledgement made in error can be reversed here, and the reversal is written to the audit trail.
| Observed | Type | Signal | Severity |
|---|
Nothing answered yet.