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SystemAIS-001Medical device and SaMD

Retinal Screening Assistant

Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.

Device class
Class IIa (MDR)
FDA
Class II, 510(k)
EU AI Act
High-risk (Annex I)
Status
In operation
State
Deployed
Owner
Cirocco Jones
Record completeness
0

100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.

The system is in operation while its record stands below the floor of 70. That contradiction is raised as blocker STATE-01.

Blockers
14

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
2 signals open, 1 of which propose restriction of this AI System.

Open signals

Most severe first. Nothing closes itself.

ObservedTypeSignalSeverity
2026-07-01Performance
Sensitivity below threshold, northern sites
Sensitivity 0.88 against a floor of 0.92 across four northern sites over the July window.
Restriction of the AI System is proposed.
Blocker
2026-07-01Drift
Image statistics drift above tolerance
Population drift metric 0.21 against a tolerance of 0.15, coincident with a camera fleet replacement at two sites.
Blocker

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.

ObservedTypeSignalSeverity
2026-07-18Complaint
Clinician reports repeated ungradable classification
Site 11 reports the quality gate rejecting images a grader considers gradable. Under triage.
Warning