Model versionMV-003
Version 2.2.0-candidate
Not deployed
- Frozen on
- 2026-07-02
- Approval
- Not approved
TrainingRetrained on DV-004 following drift on the northern sites.
PerformanceSensitivity 0.95, specificity 0.87 on DV-002. Not yet reviewed.
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
An AI Model Version is immutable once frozen. A change produces a new version; it never edits an approved one. Approval and deployment are separate acts, and each is signed.
Models
Every model maintained under this AI System, with its frozen versions. Active models are listed first; superseded and retired models are kept below.
MOD-001 · Referable disease classifier
Produce a referable / non-referable decision with a confidence value.
Model type
Convolutional image classifier
Status
Approved
Owner
Louis Wu
Repository reference
model-registry://rsa/referable/
Model versionMV-002
Version 2.1.0
Deployed
- Frozen on
- 2025-12-15
- Approval
- ReviewREV-010
TrainingRetrained on DV-003 with site rebalancing.
PerformanceSensitivity 0.94, specificity 0.89 on DV-002.
Model versionMV-001
Version 1.0.0
Approved, not deployed
- Frozen on
- 2024-11-08
- Approval
- ReviewREV-003
TrainingTrained on DV-001. 84,120 images, 6 sites.
PerformanceSensitivity 0.92, specificity 0.88 on DV-002.
- 2026-07-02Louis WuFroze model version
- 2025-12-15Louis WuFroze model version
- 2026-01-19Lilith IyapoApproved for deployment, REV-010
- 2024-11-08Louis WuFroze model version
MOD-002 · Image quality classifier
Score gradability of a captured fundus image.
Model type
Convolutional image classifier
Status
Approved
Owner
Louis Wu
Repository reference
model-registry://rsa/quality/
Model versionMV-004
Version 1.3.0
Deployed
- Frozen on
- 2025-01-22
- Approval
- ReviewREV-003
TrainingTrained on DV-002 gradability labels.
PerformanceAgreement with grader consensus 0.96.
- 2025-01-22Louis WuFroze model version
AI System Owner does not hold approval authority for this record type. Approval sits with Lilith Iyapo (Independent Reviewer). Switch persona in the header to act.