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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
Approved for operation
State
Deployed
Owner
Cirocco Jones
Readiness
0
Blockers
12

The person who authored a record cannot approve it. The persona switcher changes which decisions are available to you.

AI Reviews

A governance decision, taken independently of the record author.

REV-003 · Model approval

Approval of the initial referable classifier and quality classifier versions.

Subject records
  • MV-001 · 1.0.0
  • MV-004 · 1.3.0
Evidence
  • DHF-2291-PR-004Model performance report, release 4.0
Participants

Each person is named with what they are there to do. A required participant signs before the review can be decided.

NamePartRequiredSigned
Louis WuAuthorOptionalNot signed
Lilith IyapoApproverRequiredApproved · 2025-02-04 09:12 UTC
Cirocco JonesObserverOptionalNot signed
Signature manifest

Each entry states who signed, the part they played, what the signature means and when it was applied. Entries are appended and never altered.

SignerPartMeaningSigned onStanding
Louis WuAuthorReviewed2025-02-03 09:12 UTCStanding
Lilith IyapoApproverApproved2025-02-04 09:12 UTCStanding

Approved. Performance and suitability records are complete. by Lilith Iyapo on 2025-02-04.

REV-004 · System approval for operation

Approval of AIS-001 for operation in the European Union.

Subject records
  • AIS-001 · Retinal Screening Assistant
  • UC-001 · Primary screening triage
  • UC-002 · Image quality gating
Evidence
  • DHF-2291-RMR-003Risk management report
  • DHF-2291-HF-001Human factors validation summary
ConditionDueClosed
Report subgroup performance monthly for the first twelve months.2026-02-11Yes
Participants

Each person is named with what they are there to do. A required participant signs before the review can be decided.

NamePartRequiredSigned
Cirocco JonesAuthorOptionalNot signed
Lilith IyapoApproverRequiredApproved with conditions · 2025-02-11 09:12 UTC
Bron HelstromObserverOptionalNot signed
Signature manifest

Each entry states who signed, the part they played, what the signature means and when it was applied. Entries are appended and never altered.

SignerPartMeaningSigned onStanding
Cirocco JonesAuthorReviewed2025-02-10 09:12 UTCStanding
Lilith IyapoApproverApproved with conditions2025-02-11 09:12 UTCStanding

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

REV-010 · Change authorisation

Deployment of MV-002 under the Controlled Evolution boundaries.

Subject records
  • MV-002 · 2.1.0
  • PM-001 · Periodic retraining on extended screening archive
Evidence
  • DHF-2291-RV-002Retraining verification report, MV-002
Participants

Each person is named with what they are there to do. A required participant signs before the review can be decided.

NamePartRequiredSigned
Louis WuAuthorOptionalNot signed
Lilith IyapoApproverRequiredApproved · 2026-01-19 09:12 UTC
Signature manifest

Each entry states who signed, the part they played, what the signature means and when it was applied. Entries are appended and never altered.

SignerPartMeaningSigned onStanding
Lilith IyapoApproverApproved2026-01-19 09:12 UTCStanding

Cirocco Jones is not named on this review, so cannot sign it. Add the person as a participant first.

Approved. Change stays inside the declared modification boundaries. by Lilith Iyapo on 2026-01-19.

REV-011 · Periodic review

Annual review of AIS-001 governance state.

Subject records
  • AIS-001 · Retinal Screening Assistant
Evidence
  • No evidence linked
ConditionDueClosed
Close the drift risk RSK-003 with a verified control.2026-06-30Open
Complete the quality assessment for DV-004 before use in training.2026-08-31Open
Participants

Each person is named with what they are there to do. A required participant signs before the review can be decided.

NamePartRequiredSigned
Bron HelstromAuthorOptionalNot signed
Lilith IyapoApproverRequiredApproved with conditions · 2026-01-19 09:12 UTC
Signature manifest

Each entry states who signed, the part they played, what the signature means and when it was applied. Entries are appended and never altered.

SignerPartMeaningSigned onStanding
Lilith IyapoApproverApproved with conditions2026-01-19 09:12 UTCStanding

Cirocco Jones is not named on this review, so cannot sign it. Add the person as a participant first.

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

REV-012 · Model approval

Approval of the retrained referable classifier candidate MV-003.

Subject records
  • MV-003 · 2.2.0-candidate
  • PM-002 · Site expansion retraining
Evidence
  • No evidence linked
Participants

Each person is named with what they are there to do. A required participant signs before the review can be decided.

NamePartRequiredSigned
Louis WuAuthorOptionalNot signed
Lilith IyapoApproverRequiredNot signed
Signature manifest

Each entry states who signed, the part they played, what the signature means and when it was applied. Entries are appended and never altered.

No signature has been applied.

Cirocco Jones is not named on this review, so cannot sign it. Add the person as a participant first.

Held until every required participant has signed: Lilith Iyapo (Approver).

Decision log

IdentifierTypeStatusAuthorApproverDecided on
REV-003Model approvalApprovedLouis WuLilith Iyapo2025-02-04
REV-004System approval for operationApproved with conditionsCirocco JonesLilith Iyapo2025-02-11
REV-010Change authorisationApprovedLouis WuLilith Iyapo2026-01-19
REV-011Periodic reviewApproved with conditionsBron HelstromLilith Iyapo2026-01-19
REV-012Model approvalIn preparationLouis WuNot appointedNot recorded