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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

Use Cases

A use case records one materially distinct use of the AI System. Approval of a use case is separate from approval of the AI System for operation.

Use caseUC-003

Longitudinal progression flag

Draft
User group
Reviewing ophthalmologists
Autonomy
Advisory.
Owner
Cirocco Jones
Context
Post-screening review
Updated
2026-07-14
Models
None linked
Compare the current episode with prior episodes and flag progression for earlier recall.
Use caseUC-001

Primary screening triage

Approved
User group
Screening technicians and reviewing ophthalmologists
Autonomy
Advisory. The clinician makes the referral decision.
Owner
Cirocco Jones
Context
Community diabetic eye screening service
Updated
2025-02-11
Models
MOD-001
Rank screening episodes by likelihood of referable disease so that specialist capacity is used first on the highest-likelihood cases.
Use caseUC-002

Image quality gating

Approved
User group
Screening technicians
Autonomy
Automated rejection with technician override.
Owner
Cirocco Jones
Context
Image capture station
Updated
2025-02-11
Models
MOD-002
Reject unreadable fundus images at capture so the episode can be repeated while the patient is present.

AI System Owner does not hold approval authority for this record type. Approval sits with Bron Helstrom (Quality and Regulatory) or Lilith Iyapo (Independent Reviewer). Switch persona in the header to act.