Benefits
- Benefit
-
Rose from 0.7055 to 0.7575
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Reported benefit
Awaiting review
- 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
-
QuantX
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
-
Readers selected the lesion and the software segmented and scored it. Readers saw no prior images or patient history.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
Each radiologist read every case first without and then with the score, so the change is attributed to the software.
Awaiting review
- AI contribution
-
Each radiologist read every case first without and then with the score, so the change is attributed to the software.
Awaiting review
Measurement
- Studies
-
Quasi-experimental. [1]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [1]
- Study design
-
Quasi-experimental. [1]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [1]
- Measurement
-
Sequential first read then second read with the score; DBM MRMC analysis. [1]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [1]
- Setting and sample
-
19 radiologists; 111 breast MRI cases. [1]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [1]
- Measures
-
Reader AUC. [1]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [1]
- Comparison
-
First read without the score. [1]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [1]
- Results
-
AUC 0.7055 to 0.7575 (proper-binormal). [1]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [1]
- Additional value from AI
-
AUC difference 0.0520 (95% CI 0.0022 to 0.1018). [1]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [1]
- Limitations
-
Marginal result; trapezoidal estimate CI crossed zero; enriched cases; optimistic training material. [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: Quantitative Insights, Inc. Operator: Quantitative Insights (reader study with 19 radiologists).
Awaiting review
- Jurisdictions
-
Benefit:
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 radiologist uses the score as a concurrent aid. MR images meet the acquisition parameters in the labeling.
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-0628-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
-
Organizations: 2.
Awaiting review
- Reasons
-
Organizations: Radiologist AUC rose from 0.7055 to 0.7575 with the score in the reader study.
Awaiting review
- Observed or intended
-
Unresolved
Not reviewedUnresolved
- 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 multi-reader 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
-
QuantX was built to help radiologists assess and characterize breast abnormalities on MRI. Better characterization is that purpose.
Awaiting review
- Dates
-
Source published: 19 July 2017. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was tested in a laboratory. A reader study on an enriched set of archived MRI cases. [1]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: c51ca04801d5…
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
-
1 revision. 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 QuantX (DEN170022): decision summary. Granted 2017-07-19.
The clinical MRMC study demonstrated a marginally statistically significant improvement in reader performance diagnosing breast cancer when QuantX is used during breast MRI interpretation compared with conventional MRI interpretation without the use of QuantX.