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

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

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

Released for use. 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Withdrawn from use.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

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.

2024-03-04SystemAIS-001AI System registered
2024-03-04UDI(01)05412345000041UDI-DI not registeredThreshold recalibration for the northern sites. Performance changes, so registration is required before release.
2024-09-12DataDV-001Dataset version 1.0 frozen84,120 records
2024-09-30DataDV-002Dataset version 1.0 frozen12,480 records
2024-11-08ModelMV-001Model version 1.0.0 frozenSensitivity 0.92, specificity 0.88 on DV-002.
2025-01-22ModelMV-004Model version 1.3.0 frozenAgreement with grader consensus 0.96.
2025-02-04ReviewREV-003Model approval: ApprovedApproved. Performance and suitability records are complete.
2025-02-11ReviewREV-004System approval for operation: Approved with conditionsApproved with conditions. Subgroup monitoring is required from first deployment.
2025-02-20UDI(01)05412345000027UDI-DI supersededFirst market release of the screening classifier.
2025-10-28DataDV-003Dataset version 2.0 frozen103,660 records
2025-12-15ModelMV-002Model version 2.1.0 frozenSensitivity 0.94, specificity 0.89 on DV-002.
2026-01-19ReviewAIS-001Periodic review completed
2026-01-19ReviewREV-010Change authorisation: ApprovedApproved. Change stays inside the declared modification boundaries.
2026-01-19ReviewREV-011Periodic review: Approved with conditionsContinued operation approved. Two conditions remain open.
2026-01-19ChangePM-001Planned modification implementedRetrain the referable classifier on a newer Dataset Version of the screening archive without changing architecture, inputs, outputs, or intended purpose.
2026-01-26Release9f13c7aRelease v4.2.0Retrain on DV-003, recalibrate operating point
2026-02-04UDI(01)05412345000034UDI-DI registeredRetrained on an extended dataset version. Sensitivity and specificity both changed, so a new UDI-DI was assigned.
2026-05-11Release1a77e2bTag v4.2.1Fix DICOM loader crash on 12-bit input
2026-06-24DataDV-004Dataset version 3.0 frozen118,904 records
2026-07-01SignalPerformance: Sensitivity below threshold, northern sitesSensitivity 0.88 against a floor of 0.92 across four northern sites over the July window.
2026-07-01SignalDrift: Image statistics drift above tolerancePopulation drift metric 0.21 against a tolerance of 0.15, coincident with a camera fleet replacement at two sites.
2026-07-02ModelMV-003Model version 2.2.0-candidate frozenSensitivity 0.95, specificity 0.87 on DV-002. Not yet reviewed.
2026-07-06ReviewREV-012Model approval: In preparationApproval of the retrained referable classifier candidate MV-003.
2026-07-14ChangePM-003Planned modification draftAdjust the referral confidence threshold within a declared range in response to service capacity.
2026-07-18SignalComplaint: Clinician reports repeated ungradable classificationSite 11 reports the quality gate rejecting images a grader considers gradable. Under triage.
2026-07-20ChangePM-002Planned modification assessedRetrain on a Dataset Version that adds two northern screening sites, in response to the observed drift signal.
2026-07-22Release4de90c1Commit mainSite-level threshold recalibration, northern cohort
2026-07-27Release77b0aa3Commit #412Add second input modality: OCT volumes

Governance gates

A gate is held until it is proven. It passes when the records it depends on exist, an approved AI Review of the matching type is recorded, and no blocker in its scope is open.

Gate	Purpose	Responsible	Outcome	What is missing
Development authorisation	Authorises development against a stated intended purpose.	Independent Reviewer	Held	No approved AI Review of type Development authorisation. Open the review
Model approval	Approves an immutable AI Model Version for use.	Independent Reviewer	Held	TRACE-01 MV-004 has no training suitability record DATA-01 DV-004 has no quality assessment REPRO-01 MV-004 cannot be reproduced
System approval for operation	Approves the complete AI System for operation in a market.	Independent Reviewer	Held	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
Change authorisation	Authorises a change inside the Controlled Evolution boundaries.	Quality and Regulatory	Held	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
Resumption	Resumes operation after restriction or suspension.	Independent Reviewer	Held	The AI System is not restricted or suspended, so there is nothing to resume. Open the AI System No approved AI Review of type Resumption. Open the review 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

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.

Demonstration fill

Generate the rest of the record set

Scout drafts AI Use Cases, AI Models and versions, Datasets and versions, the dataset to model links, AI Risks, AI Reviews and Planned Modifications, all consistent with what this AI System already states. Records are added as drafts and every one carries an audit entry saying it was generated.

Open findings

12 blockers, 9 warnings.

BlockerTRACE-01MV-004 has no training suitability record
No Dataset Model record states which Dataset Version was used for training or why it is suitable.
Affects
MV-004
Effect
Blocks continued operation and PCCP generation.
Record dataset suitability
BlockerDATA-01DV-004 has no quality assessment
A Dataset Version cannot be used for training or evaluation until its quality assessment is recorded.
Affects
DV-004
Effect
Blocks model approval and change authorisation for records that use it.
Complete quality assessment
BlockerRISK-01RSK-003 residual risk is not accepted
New capture hardware shifts image characteristics away from training data. No accepted residual position is recorded.
Affects
RSK-003
Effect
Blocks continued operation and change authorisation.
Assess and control the risk
BlockerRISK-01RSK-005 residual risk is not accepted
Draft progression use case is used clinically before authorisation. No accepted residual position is recorded.
Affects
RSK-005
Effect
Blocks continued operation and change authorisation.
Assess and control the risk
BlockerREV-01REV-011 condition is overdue
Close the drift risk RSK-003 with a verified control. Owner Louis Wu, due 2026-06-30.
Affects
REV-011
Effect
Blocks change authorisation until closed.
Close the condition
BlockerMON-01Monitoring threshold breached: Sensitivity, northern sites
Observed 0.88 against threshold "Not below 0.92" on 2026-07-01.
Affects
AIS-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
AIS-001
Effect
Requires an AI Risk assessment and a change or restriction decision.
Review monitoring response
BlockerCE-01PM-003 has no impact assessment
A Planned Modification cannot be authorised or included in a PCCP without one.
Affects
PM-003
Effect
Excludes the modification from the generated PCCP.
Complete the impact assessment
BlockerREPRO-01MV-004 cannot be reproduced
No commit, environment, hyperparameters or dataset versions are recorded, so the result cannot be re-derived.
Affects
MV-004
Effect
Blocks continued operation. The deployed result is not evidenced.
Record reproducibility
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
AIS-001
Effect
Restriction is proposed. Blocks continued operation until answered.
Open the signal inbox
BlockerSIG-01Drift signal not acknowledged: Image statistics drift above tolerance
Population drift metric 0.21 against a tolerance of 0.15, coincident with a camera fleet replacement at two sites. Observed 2026-07-01.
Affects
AIS-001
Effect
Requires triage and a recorded response.
Open the signal inbox
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
WarningSTRUCT-02UC-003 references no AI Model
Use case "Longitudinal progression flag" cannot be traced to a model, so its performance cannot be evidenced.
Affects
UC-003
Effect
Blocks approval of this use case.
Link an AI Model
WarningTRACE-01MV-003 has no training suitability record
No Dataset Model record states which Dataset Version was used for training or why it is suitable.
Affects
MV-003
Effect
Blocks model approval.
Record dataset suitability
WarningTRACE-02MV-001 has no testing suitability record
Performance cannot be traced to a specific, immutable Dataset Version.
Affects
MV-001
Effect
Blocks model approval.
Record testing suitability
WarningTRACE-02MV-003 has no testing suitability record
Performance cannot be traced to a specific, immutable Dataset Version.
Affects
MV-003
Effect
Blocks model approval.
Record testing suitability
WarningREV-01REV-011 condition is open
Complete the quality assessment for DV-004 before use in training. Owner Louis Wu, due 2026-08-31.
Affects
REV-011
Effect
Must be closed before the next periodic review.
Close the condition
WarningEVID-01DHF-2291-RMR-003 is stale
Approved 2025-02-06. Review interval is 12 months.
Affects
DHF-2291-RMR-003
Effect
Weakens the mapping that depends on it.
Review the mapping
WarningREPRO-01MV-003 cannot be reproduced
No commit, environment, hyperparameters or dataset versions are recorded, so the result cannot be re-derived.
Affects
MV-003
Effect
Blocks model approval.
Record reproducibility
WarningREPO-01Repository event main has no governance response
Site-level threshold recalibration, northern cohort, Performance changes. Freeze a new AI Model Version, open a change authorisation review, and assign a new UDI-DI.
Affects
4de90c1
Effect
Change is happening in the repository ahead of the record set.
Answer the event
WarningREPO-01Repository event #412 has no governance response
Add second input modality: OCT volumes, Outside the declared Controlled Evolution boundary. Requires a new authorisation and a new Basic UDI-DI.
Affects
77b0aa3
Effect
Change is happening in the repository ahead of the record set.
Answer the event

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