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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

A Dataset Version is immutable once frozen. Suitability for a specific AI Model Version is recorded separately, on the Suitability tab.

Datasets

Every dataset registered under this AI System, with its frozen versions.

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-001

Version 1.0

Quality assessed
Frozen on
2024-09-12
Records
84,120

PopulationSix sites, 2019–2023, adults in routine screening.

Quality assessmentCompleted. Label agreement 0.91.

Data versionDV-003

Version 2.0

Quality assessed
Frozen on
2025-10-28
Records
103,660

PopulationSix sites extended to 2025, site rebalanced.

Quality assessmentCompleted. Label agreement 0.92.

Data versionDV-004

Version 3.0

Not assessed
Frozen on
2026-06-24
Records
118,904

PopulationAdds two northern sites following the drift signal.

Quality assessmentNot recorded.

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
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.