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

AI 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-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.

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.

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.