Data versionDV-004
Version 3.0
Not assessed
- In use
- Current version
- State
- Frozen · read only
- Frozen on
- 2026-06-24
- Records
- 118,904
PopulationAdds two northern sites following the drift signal.
Quality assessmentNot recorded.
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
- 0
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
- 14
A Dataset Version is immutable once frozen. Nothing here edits a version that already exists: freezing always creates a new version, and an existing version can be chosen as its starting point. Suitability for a specific Model Version is recorded separately, on the Suitability tab.
Datasets
Every dataset registered under this AI System, with its frozen versions. Retired and restricted datasets are kept below.
DS-001 · Screening image archive
Six participating screening services, consented research use
Status
Released
Data category
Colour fundus images with grader labels
Personal data
Yes
PIMS reference
PIMS-ROPA-114
Data versionDV-003
Version 2.0
Quality assessed
- In use
- Superseded
- State
- Frozen · read only
- Frozen on
- 2025-10-28
- Records
- 103,660
PopulationSix sites extended to 2025, site rebalanced.
Quality assessmentCompleted. Label agreement 0.92.
Data versionDV-001
Version 1.0
Quality assessed
- In use
- Superseded
- State
- Frozen · read only
- Frozen on
- 2024-09-12
- Records
- 84,120
PopulationSix sites, 2019–2023, adults in routine screening.
Quality assessmentCompleted. Label agreement 0.91.
DS-002 · Independent evaluation set
Two services excluded from all training data
Status
Released
Data category
Colour fundus images with adjudicated labels
Personal data
Yes
PIMS reference
PIMS-ROPA-115
Data versionDV-002
Version 1.0
Quality assessed
- In use
- Current version
- State
- Frozen · read only
- Frozen on
- 2024-09-30
- Records
- 12,480
PopulationTwo held-out sites, adjudicated by three graders.
Quality assessmentCompleted. Adjudication protocol EV-005.
This record type is normally maintained by Data Science. You are acting as AI System Owner; the audit trail will say so.