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

Lifecycle

Where the system stands, and the act that moves it on. Every move is written to the audit trail under the acting persona.

Registered

The system exists as a record. Design work has not started.

In development

Design and development are under way. Nothing is in use outside the project.

Approved for operation

The release decision is taken and the record supports it. The system is not yet in use, so the post-market duties have not started.

In operation

In use outside the project. The post-market duties apply from this point.

Under restriction

In use, but with a limitation placed on it after a signal or a finding.

Suspended

Use is stopped while a matter is settled.

Retired

Withdrawn from use. Records are held for the retention period.

Move to

Rationale

Identity

What the system is, where it is placed, and how often it is reviewed.

Description

Software as a medical device deployed in screening clinics. The system reads fundus image pairs, produces a referral recommendation and a confidence value, and returns both to the reviewing clinician. The clinician retains the decision.

Markets

European Union, United States

Sectoral class

Class IIa (MDR), Class II (FDA)

FDA position

Class II · 510(k)

EU AI Act tier

High-risk (Annex I)

QMS reference

QMS-DHF-2291

Deployed configuration

RSA 4.2.0 / MV-002

Placed on market

Yes

Internal reviews

12 months, next due 2027-01-19 Open AI Reviews

Linked records

Navigate from the AI System to every governed record.

Planned Modifications

Chronology

Every dated act on this AI System and its records, in order.

2026-07-27Release77b0aa3Commit #412Add second input modality: OCT volumes
2026-07-22Release4de90c1Commit mainSite-level threshold recalibration, northern cohort
2026-07-20ChangePM-002Planned modification assessedRetrain on a Dataset Version that adds two northern screening sites, in response to the observed drift signal.
2026-07-18SignalComplaint: Clinician reports repeated ungradable classificationSite 11 reports the quality gate rejecting images a grader considers gradable. Under triage.
2026-07-14ChangePM-003Planned modification draftAdjust the referral confidence threshold within a declared range in response to service capacity.
2026-07-06ReviewREV-012Model approval: In preparationApproval of the retrained referable classifier candidate MV-003.
2026-07-02ModelMV-003Model version 2.2.0-candidate frozenSensitivity 0.95, specificity 0.87 on DV-002. Not yet reviewed.
2026-07-01SignalPerformance: Sensitivity below threshold, northern sitesSensitivity 0.88 against a floor of 0.92 across four northern sites over the July window.

Governance gates

A gate is held until it is proven. Each card states what is already in place and, plainly, the single next act that would move it. A gate can hold on one unmet item while everything else is done.

Development authorisation

Authorises development against a stated intended purpose.

Held

Next act

No approved AI Review of type Development authorisation. Open the review

In place · 2

The intended purpose is not stated on the AI System.
No AI Use Case is recorded, so there is nothing to authorise development against.

Responsible · Independent Reviewer

Model approval

Approves an immutable AI Model Version for use.

Held

Next act

Every requirement is in place. The gate is held by open blockers below.

TRACE-01 MV-004 has no training suitability record
DATA-01 DV-004 has no quality assessment
REPRO-01 MV-004 cannot be reproduced

In place · 3

No AI Model Version exists, so there is nothing to approve.
No Dataset Version is linked to a model version for training.
No approved AI Review of type Model approval.

Responsible · Independent Reviewer

System approval for operation

Approves the complete AI System for operation in a market.

Held

Next act

Every requirement is in place. The gate is held by open blockers below.

AIACT-49 Not registered in the EU database
RISK-01 RSK-003 residual risk is not accepted
RISK-01 RSK-005 residual risk is not accepted
REPRO-01 MV-004 cannot be reproduced
UDI-02 UDI-DI (01)05412345000041 is not registered

In place · 3

No AI Risk is recorded, so the risk position is unstated.
No AI Use Case is approved.
No approved AI Review of type System approval for operation.

Responsible · Independent Reviewer

Change authorisation

Authorises a change inside the Controlled Evolution boundaries.

Held

Next act

Every requirement is in place. The gate is held by open blockers below.

RISK-01 RSK-003 residual risk is not accepted
RISK-01 RSK-005 residual risk is not accepted
REV-01 REV-011 condition is overdue
MON-01 Monitoring threshold breached: Sensitivity, northern sites
MON-01 Monitoring threshold breached: Image statistics drift
CE-01 PM-003 has no impact assessment
SIG-01 Performance signal not acknowledged: Sensitivity below threshold, northern sites
SIG-01 Drift signal not acknowledged: Image statistics drift above tolerance

In place · 3

No Controlled Evolution boundary is recorded for this AI System.
No Planned Modification has been assessed.
No approved AI Review of type Change authorisation.

Responsible · Quality and Regulatory

Resumption

Resumes operation after restriction or suspension.

Held

Next act

The AI System is not restricted or suspended, so there is nothing to resume. Open the AI System

Then 1 further requirement.

RISK-01 RSK-003 residual risk is not accepted
RISK-01 RSK-005 residual risk is not accepted
REV-01 REV-011 condition is overdue
MON-01 Monitoring threshold breached: Sensitivity, northern sites
MON-01 Monitoring threshold breached: Image statistics drift
SIG-01 Performance signal not acknowledged: Sensitivity below threshold, northern sites
SIG-01 Drift signal not acknowledged: Image statistics drift above tolerance

Responsible · Independent Reviewer

Posture summary

Compliance posture narrative

A written summary of the computed findings and the recommended order of work. The findings themselves are deterministic. The narrative never states that the AI System is compliant.

Open findings

14 blockers, 9 warnings. Readiness is 100, less 12 for each open blocker and 4 for each open warning. It measures how much of the record is unfinished, not how well the AI System performs.

BlockerUDI-02UDI-DI (01)05412345000041 is not registered
Threshold recalibration for the northern sites. Performance changes, so registration is required before release. A change that affects performance or safety carries a new UDI-DI, and that UDI-DI is registered before the version is placed on the market.
Affects
(01)05412345000041
Effect
Blocks release of this version.
Register the UDI-DI
BlockerAIACT-49Not registered in the EU database
A high-risk system listed in Annex III is registered under Article 49(1) before it is placed on the market or put into service.
Affects
SystemAIS-001
Effect
Blocks placing on the market.
Record the registration
BlockerMON-01Monitoring threshold breached: Sensitivity, northern sites
Observed 0.88 against threshold "Not below 0.92" on 2026-07-01.
Affects
SystemAIS-001
Effect
Requires an AI Risk assessment and a change or restriction decision.
Review monitoring response
BlockerMON-01Monitoring threshold breached: Image statistics drift
Observed 0.21 against threshold "Not above 0.15" on 2026-07-01.
Affects
SystemAIS-001
Effect
Requires an AI Risk assessment and a change or restriction decision.
Review monitoring response
BlockerSIG-01Performance signal not acknowledged: Sensitivity below threshold, northern sites
Sensitivity 0.88 against a floor of 0.92 across four northern sites over the July window. Observed 2026-07-01.
Affects
SystemAIS-001
Effect
Restriction is proposed. Blocks continued operation until answered.
Open the signal inbox

Monitoring

Signals observed on the deployed configuration.

Metric	Observed	Threshold	State	Observed on
Sensitivity, all sites	0.93	Not below 0.92	Within threshold	2026-07-01
Sensitivity, northern sites	0.88	Not below 0.92	Breached	2026-07-01
Image statistics drift	0.21	Not above 0.15	Breached	2026-07-01
Clinician override rate	6.1%	Not above 10%	Within threshold	2026-07-01

Framework mappings

A mapping records where a requirement is addressed. It does not assert compliance.

Framework	Clause	How it is addressed	Evidence
EU AI Act	Article 9, Risk management system	AI Risk records maintain hazard, control, and residual acceptance state across the life cycle.	DHF-2291-RMR-003
EU AI Act	Article 10, Data and data governance	Dataset Versions are immutable and their suitability for each AI Model Version is recorded.	DHF-2291-DGS-002
ISO/IEC 42001	8.3, AI system impact assessment	Impact assessment is recorded per Planned Modification.	Not linked
EN 18286	6.2, Data quality	Dataset quality assessment is required before release.	DHF-2291-AP-001
ISO 14971	7, Risk control	Risk controls are verified before system approval.	DHF-2291-RMR-003

Audit trail

2024-03-04Cirocco JonesRegistered AI System
2025-02-11Lilith IyapoApproved for operation, REV-004
2026-01-19Lilith IyapoCompleted periodic review, REV-011
2026-07-14Cirocco JonesOpened Controlled Evolution revision 3