LibraryFamily 1 · Diagnostic Imaging & Pathology
Digital pathology decision support for prostate cancer
CuratedPilotEmerging evidence
Reviewed for completeness and published to the Library.
Highlights tissue regions on digitised prostate biopsy slides suspicious for cancer to support the reporting pathologist.
Plain-language summary
AIChoose an audience and generate a tailored summary on demand. The AI uses only what is on this page.
Clinical context
- Clinical problem
- Detect a condition
- Point of care
- Diagnosis
- Nature of AI output
- A classification
- Clinical specialty
- Pathology
- Care setting
- Hospital — outpatient
- Patient population
- Prostate core needle biopsy specimens from men referred for suspected prostate cancer.
- Intended use
- Highlights tissue regions on digitised prostate biopsy slides suspicious for cancer to support the reporting pathologist.
Technology
- AI technique
- Deep learning, Computer vision
- Input data
- Medical imaging
- Output type
- Classification
- Autonomy level
- Informs a human (advisory)
- Model provenance
- Vendor proprietary
- Model version
- Prostate v2.0
- Built on a general-purpose model
- No
Deployment
- Status
- Pilot
- Country
- Sweden
- Deployment date
- 10 February 2025
- Sites
- 1
Regulatory & governance
- EU AI Act risk tier
- High-risk
- High-risk basis
- Annex I — medical device
- Medical device
- Yes
- EU MDR class
- Class IIa
- CE marking
- CE marked
- FDA status
- De Novo
- ISO 14971 risk class
- Not assessed
- GDPR processing basis
- Public interest
- GDPR DPIA
- Completed
- Data identifiability
- Pseudonymised
- Explainability method
- Post-hoc
- Human oversight model
- Pathologist reviews every slide; AI output is an overlay, not a diagnosis.
NICE evidence standards
- ESF tier
- Tier C — treat / diagnose / calculate risk
- Evidence category
- —
Performance summary
- Headline metric
- AUC / AUROC
- Value
- 0.97
- Subgroup performance assessed
- No
- Known bias signals
- —
Similar deployments
AILooking for close matches in the Library…
Evidence records
Studies and evaluations attached to this use case.
Retrospective validation
AUC / AUROC: 0.97
Population: Prostate biopsy slides, 2k specimens
Contributors
- Deploying organisation
- [demo] Karolinska University Hospital · Hospital / health system · Sweden
- AI vendor
- [demo] Paige AI · United States
- Product name
- Paige Prostate