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

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

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
Data versionDV-001 1.0	Model versionMV-001 1.0.0	Training	Suitable	Population matches the intended screening population. Grading protocol equals the deployed protocol.	2024-11-04 · Louis Wu
Data versionDV-002 1.0	Model versionMV-002 2.1.0	Testing	Suitable	Held-out sites, adjudicated labels, no overlap with DV-003.	2025-12-18 · Louis Wu
Data versionDV-003 2.0	Model versionMV-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
Data versionDV-002 1.0	Model versionMV-004 1.3.0	Testing	Suitable	Gradability labels available for the full evaluation set.	2025-01-25 · Louis Wu