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
Why this exists
A record says what happened. A reproducibility entry lets someone else get the same result. It names the commit, the environment, the parameters and the exact dataset versions, and hashes them together. 2 model versions cannot currently be re-derived.
Ledger
One entry per AI Model Version. Entries are not edited.
| Version | Commit | Environment | Parameters | Dataset versions | Hash | Recorded |
|---|---|---|---|---|---|---|
| MV-001 1.0.0 | e2740c81b9 | python 3.11, torch 2.3.1, cuda 12.1, container sha256:4f9a… | lr 3e-4, batch 32, epochs 40, seed 20240517, augmentation set A | DV-001, DV-002 | rp-7f21c9d4 | 2024-11-08 |
| MV-002 2.1.0 | 9f13c7a2e5 | python 3.11, torch 2.4.0, cuda 12.4, container sha256:aa10… | lr 2e-4, batch 32, epochs 55, seed 20260112, augmentation set B | DV-003, DV-002 | rp-1c8e0b62 | 2026-01-26 |
| MV-003 2.2.0-candidate | Not recorded | Not recorded | Not recorded | Not recorded | Not recorded | Not recorded |
| MV-004 1.3.0 | Not recorded | Not recorded | Not recorded | Not recorded | Not recorded | Not recorded |
A model version without a reproducibility entry blocks model approval, and blocks continued operation once deployed. Record the commit when the version is frozen, not afterwards.