Benefits
- Benefit
-
An AUC of 0.70, above a goal of 0.64
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Intended. The study applied the software retrospectively to stored mammograms and the predictions informed no screening decision, so the sources report no realized benefit. [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
-
Allix5
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
-
The software analyzed all four standard views of a bilateral screening mammogram. Exams came from Hologic Lorad Selenia and Selenia Dimensions systems.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The study compared the software with a fixed performance goal. It did not run traditional risk models on the same exams or compare care 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
-
Retrospective validation of five-year risk predictions against biopsy-proven cancer and follow-up mammography, adjusted for censoring. [1]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [1]
- Setting and sample
-
77,511 exams from 44,112 patients at five US screening sites not used for training. [1]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [1]
- Measures
-
Time-dependent AUC at five years and calibration (modified GND test). [1]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [1]
- Comparison
-
Fixed performance goal of 0.64. [1]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [1]
- Results
-
AUC 0.70 overall; 0.66 excluding current cancers; calibration endpoints met. [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
-
Retrospective; no same-sample comparison with traditional models; overestimation in the highest decile for patients without current cancer. [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: Clairity, Inc. Operator: Clairity (retrospective study on mammograms from five US screening sites).
Awaiting review
- Jurisdictions
-
Benefit: Atlanta, Georgia; Fort Worth and Bedford, Texas; Sacramento and Folsom, California,
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 eligible for screening mammography. The clinician uses the risk output for supplemental screening or risk reduction decisions and does not use it to read the mammogram.
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-0632-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 discrimination was measured retrospectively against a fixed goal, and no screening site used the predictions to change care.
Awaiting review
- Observed or intended
-
Intended. The study applied the software retrospectively to stored mammograms and the predictions informed no screening decision, so the sources report no realized benefit. [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 retrospective 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
-
Allix5 was built to give a five-year breast cancer risk prediction from a screening mammogram to inform supplemental screening and risk reduction. The measured risk prediction is that purpose.
Awaiting review
- Dates
-
Source published: 30 May 2025. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was tested in a laboratory. A retrospective study on archived mammograms; the software did not guide care. [1]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 79f30d3a2086…
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 Allix5 (DEN240047): decision summary. Granted 2025-05-30.
This benefit is supported by the superior discrimination result (AUC(5): 0.70) with 95% confidence interval (0.69, 0.72) being above the performance goal of 0.64, informed by the traditional risk models.