Benefits
- Benefit
-
A detection rate of 6.4 per 1,000 against 5.0 per 1,000
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Reported benefit
Awaiting review
- Beneficiary groups
-
People. 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
-
Transpara
Awaiting review
- Model
-
This is an explicit unresolved assignment: the sources on record do not settle this question.
Not reviewedUnresolved
- Reported configuration
-
1.7.0
Awaiting review
- Provider
-
Unresolved
Not reviewedUnresolved
- Role
-
Unresolved
Not reviewedUnresolved
- Configuration
-
Unresolved
Not reviewedUnresolved
- Inputs and outputs
-
Unresolved
Not reviewedUnresolved
- Autonomy
-
Unresolved
Not reviewedUnresolved
- Workflow
-
Transpara 1.7.0 scored every screening examination on a scale from 1 to 10. Examinations scored 10 went to double reading and all others to single reading. Readers saw the AI risk scores and detection marks while reading. The trial ran inside an organized population screening program with experienced breast radiologists.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The trial randomly assigned women to AI-supported screening or to standard double reading without AI, so the difference in outcomes reflects the AI-supported workflow. The design does not separate the effect of triage from the effect of the detection marks.
Awaiting review
- AI contribution
-
The trial randomly assigned women to AI-supported screening or to standard double reading without AI, so the difference in outcomes reflects the AI-supported workflow. The design does not separate the effect of triage from the effect of the detection marks.
Awaiting review
Measurement
- Studies
- Study design
- Measurement
-
Study 1: Interval cancers from registry follow-up; sensitivity and specificity. Study 2: Screen-detected cancers, recalls and screen readings. [1] [2]
- Setting and sample
-
Study 1: 105,934 women screened at four sites in southwest Sweden, 12 April 2021 to 7 December 2022. Study 2: 105,915 women analyzed. [1] [2]
- Measures
-
Study 1: Interval cancer rate per 1,000 participants. Study 2: Cancer detection rate per 1,000 and screen-reading workload. [1] [2]
- Comparison
-
Study 1: Standard double reading without AI. Study 2: Standard double reading without AI. [1] [2]
- Results
-
Study 1: 1.55 vs 1.76 per 1,000; proportion ratio 0.88 (95% CI 0.65 to 1.18), non-inferior; sensitivity 80.5% vs 73.8%. Study 2: 6.4 vs 5.0 per 1,000 (ratio 1.29); 44.2% fewer screen readings. [1] [2]
- Additional value from AI
-
Study 1: Sensitivity 6.7 percentage points higher with AI. Study 2: 1.4 more cancers per 1,000 women. [1] [2]
- Limitations
-
Study 1: Interval cancer difference not statistically significant; one AI product; mortality not measured. Study 2: Some extra cancers may be overdiagnosed in situ disease. [1] [2]
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: ScreenPoint Medical. Operator: Unilabs Mammography Unit at Skåne University Hospital with Lund University (MASAI trial, Swedish national screening program).
Awaiting review
- Jurisdictions
-
Benefit: Malmö, Lund, Landskrona and Trelleborg, Skåne,
Sweden. Developer:
Netherlands. Operator:
Sweden.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
-
Readers must have the AI scores and marks in front of them when they read. The AI must perform on the local equipment and population as it did in the trial. The program must use double reading that the AI triage can replace for low-risk examinations.
Awaiting review
- Replication attempts
-
3 follow-up entries. Benefit recurred: 3.
Awaiting review
- 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-0642-source-0001–0005
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
-
Independently studied. Sources: five independent peer-reviewed studies. The cited evidence includes no finding by a regulator or court. [1] [2] [3] [4] [5]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
People. Organizations.
Awaiting review
- Depth
-
People: 4. Organizations: 2.
Awaiting review
- Reasons
-
People: Women in the AI group had 338 cancers found at screening against 262 in the control group, and the extra invasive cancers were mainly small and node-negative. Organizations: The screening service needed 61,248 screen readings in the AI group against 109,692 in the control group, a 44.2% reduction.
Awaiting review
- Observed or intended
-
Unresolved
Not reviewedUnresolved
- Rubric
-
Unresolved
Not reviewedUnresolved
- Assessor and date
-
Unresolved
Not reviewedUnresolved
- Alternative assessments
-
Unresolved
Not reviewedUnresolved
- Fill
-
Independently studied
Awaiting review
Entry details
- Kind
-
The case describes an evaluation or a study. A randomized controlled screening trial. [1]
Fully reviewedDetails: 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 reviewedUnresolvedDetails: supporting details for Related entries
Compared with the incidents in the AI Incident Database snapshot of 26 October 2026.
- Field
-
Healthcare.
Awaiting review
- Purpose
-
Transpara was built to detect breast cancer on screening mammograms and to score examinations by risk. In MASAI it triaged examinations to single or double reading and marked suspicious findings; the higher detection and the saved reading time were that purpose.
Awaiting review
- Dates
-
Observed: 7 December 2022. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was used in a pilot. A randomized trial inside the national screening program at four sites; the papers do not report a later routine rollout. [1]
Fully reviewedDetails: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 3c6ec576532e…
Awaiting reviewDetails: 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
-
Peer-reviewed study Independent author
Interval cancer rates were 1·55 (95% CI 1·23-1·92) and 1·76 (1·42-2·15) per 1000 participants in the intervention and control group respectively, a non-inferior proportion ratio of 0·88 (95% CI 0·65-1·18; p=0·41).
-
Peer-reviewed study Independent author
Cancer-detection rates were 6·4 per 1000 (95% CI 5·7-7·1) screened participants in the intervention group and 5·0 per 1000 (4·4-5·6) in the control group, a ratio of 1·29 (95% CI 1·09-1·51; p=0·0021).
-
Peer-reviewed study Independent author
The AI system (Transpara version 1.7.0) provided an examination-based malignancy risk score on a 10-level scale that was used to triage screening examinations to single reading (score 1-9) or double reading (score 10)
-
Peer-reviewed study Independent author
Efficiency signals included 44.3% fewer total readings in MASAI
-
Peer-reviewed study Independent author
Across randomised and paired prospective trials (k = 3), the pooled detection rate ratio was 1.13 (0.83-1.55), with the MASAI randomised trial alone reporting 1.29 (1.09-1.51) and a 44% reduction in screen reading.
Collections: Cross-border cases.