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

Two duties are answered on this page. The record must state what produced a result · EU AI Act Annex IV(2)(b) to (g) for the development process, data and training method, and ISO/IEC 42001 A.6.2.6 for the verification of an AI system. And the result must be re-derivable by someone who did not build it, which is what FDA Good Machine Learning Practice asks of a model whose performance is claimed.

Where this AI System stands

2 model versions cannot currently be re-derived. A version without a commit, an environment and its dataset versions states a result that cannot be checked, and it cannot be approved. 2 repository events have no governance response yet.

Ledger

One entry per AI Model Version. An entry is written when the version is frozen, and it is corrected only with a stated reason.

Model versionMV-001 · version 1.0.0

Referable disease classifier · frozen 2024-11-08

Commit

e2740c81b95a

Environment

python 3.11, torch 2.3.1, cuda 12.1, container sha256:4f9a…

Parameters

lr 3e-4, batch 32, epochs 40, seed 20240517, augmentation set A

Dataset versions

Data versionDV-001 Data versionDV-002

Hash

rp-7f21c9d4

Recorded

2024-11-08

Model versionMV-002 · version 2.1.0

Referable disease classifier · frozen 2025-12-15

Commit

9f13c7a2e5b8

Environment

python 3.11, torch 2.4.0, cuda 12.4, container sha256:aa10…

Parameters

lr 2e-4, batch 32, epochs 55, seed 20260112, augmentation set B

Dataset versions

Data versionDV-003 Data versionDV-002

Hash

rp-1c8e0b62

Recorded

2026-01-26

Model versionMV-003 · version 2.2.0-candidate

Referable disease classifier · frozen 2026-07-02

Nothing is recorded. This version cannot be re-derived, and model approval is held until it is.

Model versionMV-004 · version 1.3.0

Image quality classifier · frozen 2025-01-22

Nothing is recorded. This version cannot be re-derived, and model approval is held until it is.

Source repository

The connection that binds a model version to the code that produced it. Events awaiting a governance response come first.

Provider

GitHub

Repository

clinical-ai/retinal-screening

Default branch

main

Last sync

2026-07-29

Open events

Date	Type	Reference	Commit	Message	Consequence
2026-07-27	pull-request	#412	77b0aa3	Add second input modality: OCT volumes a.nowak	Outside the declared Controlled Evolution boundary. Requires a new authorisation and a new Basic UDI-DI.
2026-07-22	push	main	4de90c1	Site-level threshold recalibration, northern cohort tim.verstraete	Performance changes. Freeze a new AI Model Version, open a change authorisation review, and assign a new UDI-DI.
2026-05-11	tag	v4.2.1	1a77e2b	Fix DICOM loader crash on 12-bit input tim.verstraete	Defect correction. Evaluate as UDI-PI only.	Answered
2026-01-26	release	v4.2.0	9f13c7a	Retrain on DV-003, recalibrate operating point tim.verstraete	Freeze AI Model Version MV-002 and run the UDI change evaluation.	Answered