Benefits
- Benefit
-
10-year metastasis risk was 28.1% in its high risk category
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Intended. The validation measured how well the risk categories track 10-year metastasis in patients whose outcomes were already recorded, and no source reports that physicians used the estimates to guide care or that any patient's outcome changed. [1]
Fully reviewed: supporting details for Status
Review date: 29 October 2026.
Sources: [1]
- Beneficiary groups
-
Organizations.
Awaiting review
- Beneficiaries
-
Unresolved
Not reviewedUnresolved
- Reach
-
Unresolved
Not reviewedUnresolved
- Distribution and access
-
Unresolved
Not reviewedUnresolved
- Duration
-
Unresolved
Not reviewedUnresolved
- Expected?
-
Yes
Awaiting review
- Costs and harms
-
Unresolved
Not reviewedUnresolved
AI system
- System
-
ArteraAI Prostate
Awaiting review
- Model
-
This is an explicit unresolved assignment: the sources on record do not settle this question.
Not reviewedUnresolved
- Release
-
Unresolved
Not reviewedUnresolved
- Provider
-
Unresolved
Not reviewedUnresolved
- Role
-
Unresolved
Not reviewedUnresolved
- Configuration
-
Unresolved
Not reviewedUnresolved
- Inputs and outputs
-
Unresolved
Not reviewedUnresolved
- Autonomy
-
Unresolved
Not reviewedUnresolved
- Workflow
-
Slides with the highest Gleason score were scanned on a Philips Ultra Fast scanner at 40x. A pathologist confirmed cancer on the slide and released the report.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The study measured how the software's categories track later metastasis. It did not compare decisions or outcomes with and without the software.
Awaiting review
- AI contribution
-
Unresolved
Not reviewedUnresolved
Measurement
- Studies
-
Other. [1]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [1]
- Study design
-
Other. [1]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [1]
- Measurement
-
Prognostic validation of risk categories against observed 10-year distant metastasis. [1]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [1]
- Setting and sample
-
886 patients at three US sites. [1]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [1]
- Measures
-
10-year risk of distant metastasis by risk category. [1]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [1]
- Comparison
-
Overall cohort risk. [1]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [1]
- Results
-
High 28.1%, low 3.3%, overall 8.1%. [1]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [1]
- Additional value from AI
-
Not isolated. [1]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [1]
- Limitations
-
No comparison of decisions with and without the software; few African American patients (72). [1]
Fully reviewed: supporting details for Limitations
Review date: 29 October 2026.
Sources: [1]
Money
- Kind of value
-
The kind of monetary value is unclear.
Not reviewedUnresolved
- Amount
-
The monetary value is not established.
Not reviewedUnresolved
- Currency and prices
-
The currency and price basis are unclear.
Not reviewedUnresolved
- Period and unit
-
The period and unit of the monetary estimate are unclear.
Not reviewedUnresolved
- Realization
-
Whether the monetary value was realized is unclear.
Not reviewedUnresolved
- Recipients and payers
-
The recipients and payers are unclear.
Not reviewedUnresolved
- Gross or net
-
Whether the monetary figure includes costs is unclear.
Not reviewedUnresolved
- Included costs
-
The costs included in the estimate are unclear.
Not reviewedUnresolved
- Comparison
-
The financial comparison is not established.
Not reviewedUnresolved
- Method
-
The method used to calculate monetary value is unclear.
Not reviewedUnresolved
- Return and payback
-
The return on investment or payback period is not established.
Not reviewedUnresolved
People and places
- Participants
-
Developer: Artera, Inc. Operator: Artera (clinical validation at three US sites).
Awaiting review
- Jurisdictions
-
Benefit: Three sites,
United States. Developer: United States. Operator: United States.Awaiting review
- Ownership and control
-
Unresolved
Not reviewedUnresolved
- Dependencies
-
Unresolved
Not reviewedUnresolved
- Cross-border connections
-
Unresolved
Not reviewedUnresolved
- Geopolitical implications
-
The geopolitical implications are unclear.
Not reviewedUnresolved
Follow-up
- Conditions for replication
-
The patient is a man aged 55 or older with non-metastatic prostate cancer who is a candidate for curative intent management. Physicians use the risk estimate together with other clinical and pathological factors.
Awaiting review
- Replication attempts
-
Unresolved
Not reviewedUnresolved
- Later findings
-
Unresolved
Not reviewedUnresolved
- Availability
-
Unresolved
Not reviewedUnresolved
- Institutional decision
-
A relevant institutional decision has not been established.
Not reviewedUnresolved
- Grounds
-
The grounds for an institutional decision are unclear.
Not reviewedUnresolved
- Action and result
-
The result of an institutional decision is not established.
Not reviewedUnresolved
- Success criterion
-
The criterion for a successful institutional decision is unclear.
Not reviewedUnresolved
Evidence
- Source numbers
-
AIBD-0633-source-0001
Awaiting review
- Citations
-
Numbered references below.
Awaiting review
- Language
-
Unresolved
Not reviewedUnresolved
- Source relationships
-
Independent
Awaiting review
- Original evidence
-
Unresolved
Not reviewedUnresolved
- Access and versions
-
Unresolved
Not reviewedUnresolved
- Supported findings
-
Unresolved
Not reviewedUnresolved
- Evidence links
-
Unresolved
Not reviewedUnresolved
- Evidence strength
-
Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report. [1]
Fully reviewed: supporting details for Evidence strength
Review date: 29 October 2026.
Sources: [1]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
Organizations.
Awaiting review
- Depth
-
The revised record no longer states this information.
Not reviewedUnresolved: supporting details for Depth
The record revision removed the mapped value.
- Reasons
-
Organizations: The study tested how well the categories separate risk and did not test whether treatment guided by the software changed outcomes.
Awaiting review
- Observed or intended
-
Intended. The validation measured how well the risk categories track 10-year metastasis in patients whose outcomes were already recorded, and no source reports that physicians used the estimates to guide care or that any patient's outcome changed. [1]
Fully reviewed: supporting details for Observed or intended
Review date: 29 October 2026.
Sources: [1]
- Rubric
-
Unresolved
Not reviewedUnresolved
- Assessor and date
-
Unresolved
Not reviewedUnresolved
- Alternative assessments
-
Unresolved
Not reviewedUnresolved
- Fill
-
Found by a regulator
Awaiting review
Entry details
- Kind
-
The case describes an evaluation or a study. A regulatory review of a prognostic validation study. [1]
Fully reviewed: supporting details for Kind
Review date: 29 October 2026.
Sources: [1]
- Related entries
-
No incident in the AI Incident Database snapshot of 26 October 2026 concerns the same kind of system harming the same kind of stakeholder.
Partly reviewedUnresolved: supporting details for Related entries
Compared with the incidents in the AI Incident Database snapshot of 26 October 2026.
- Field
-
Healthcare.
Awaiting review
- Purpose
-
ArteraAI Prostate was built to give physicians 10-year risk estimates of metastasis and prostate cancer death to support treatment decisions. The measured risk separation is that purpose.
Awaiting review
- Dates
-
Source published: 31 July 2025. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was tested in a laboratory. A validation study on biopsy slides with known outcomes; the software did not guide care. [1]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 423b93059079…
Awaiting review: supporting details for Version
SHA-256 of the public case, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.
References
- Other identifiers
-
Unresolved
Not reviewedUnresolved
- Category mappings
-
Unresolved
Not reviewedUnresolved
- Citable summary
-
Unresolved
Not reviewedUnresolved
- Revisions
-
2 revisions. Latest: 29 October 2026.
Awaiting review
Sources
-
Regulatory document Independent author
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for ArteraAI Prostate (DEN240068): decision summary. Granted 2025-07-31.
The pivotal clinical performance study showed that the 10-year risk of DM for ArteraAI Prostate risk category High (28.1%) is statistically significantly higher than the overall risk (8.1%) and this difference (20.0%) is clinically significant.