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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
ISO/IEC 23053:2022

Framework for AI systems using machine learning

The machine learning pipeline, traced to datasets, model versions and monitoring.

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All standards
0 covered · 1 partial · 5 open
Working a clause
Select a clause on the left. Link the records that carry the traceability, state how they address it, and attest it. A clause is covered once it is attested.

Clauses

Left, the clause list. Right, the clause you are working.

8.2

Data acquisition

Open

State the source, the collection method and the coverage of the data acquired.

Nothing is linked to 8.2. Link the Dataset or Data version record that addresses it and state how.

Records of the kind this clause expects
Other records of this AI System
External Documents
Evidence

One reference for this clause. Link evidence already held, or register it here with its location or file.