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
- Approved for operation
- State
- Deployed
- Owner
- Cirocco Jones
- Readiness
- 0
- Blockers
- 12
Suitability is stated per pairing. A Dataset Version that is suitable for one AI Model Version is not automatically suitable for another.
Bringing data to a model
Linking is three fields: which dataset version, which model version, and whether it trains, tests or monitors. The link is created immediately as Not assessed, and the suitability conclusion follows. Every link carries a conclusion.
Link matrix
Dataset versions down, model versions across. A filled cell is a recorded use.
| Dataset version | MV-001 1.0.0 | MV-002 2.1.0 | MV-003 2.2.0-candidate | MV-004 1.3.0 |
|---|---|---|---|---|
| DV-001 1.0 | Tr | , | , | , |
| DV-002 1.0 | , | Te | , | Te |
| DV-003 2.0 | , | Tr | , | , |
| DV-004 3.0 | , | , | , | , |
Tr training · Va validation · Te testing · Mo monitoring. Outline means the suitability conclusion is still open.
Dataset Models
Each row links one Dataset Version to one AI Model Version for one activity.
| Dataset Version | AI Model Version | Activity | Conclusion | Rationale | Assessed | |
|---|---|---|---|---|---|---|
| DV-001 1.0 | MV-001 1.0.0 | Training | Suitable | Population matches the intended screening population. Grading protocol equals the deployed protocol. | 2024-11-04 · Louis Wu | |
| DV-002 1.0 | MV-002 2.1.0 | Testing | Suitable | Held-out sites, adjudicated labels, no overlap with DV-003. | 2025-12-18 · Louis Wu | |
| DV-003 2.0 | MV-002 2.1.0 | Training | Suitable with conditions | Site rebalancing corrects the 2024 imbalance. Northern sites remain under-represented. Conditions: Monitor northern site performance monthly until DV-004 is released. | 2025-12-18 · Louis Wu | |
| DV-002 1.0 | MV-004 1.3.0 | Testing | Suitable | Gradability labels available for the full evaluation set. | 2025-01-25 · Louis Wu |