Benefits
- Benefit
-
The three together found 269 cancers against 250 by the radiologists alone
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Reported benefit
Awaiting review
- Beneficiary groups
-
People.
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
-
Lunit INSIGHT MMG
Awaiting review
- Model
-
This is an explicit unresolved assignment: the sources on record do not settle this question.
Not reviewedUnresolved
- Reported configuration
-
1.1.6
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
-
The AI read every examination as an independent reader alongside two radiologists. Any abnormal read by any reader sent the examination to a consensus discussion. Radiologists in the consensus discussion saw the AI score and the marked area.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
In a paired design, every examination was read by two radiologists and by the AI, and the authors counted the cancers found by each reader combination, so the cancers that only the AI flagged are attributable to it.
Awaiting review
- AI contribution
-
In a paired design, every examination was read by two radiologists and by the AI, and the authors counted the cancers found by each reader combination, so the cancers that only the AI flagged are attributable to it.
Awaiting review
Measurement
- Studies
-
Controlled observational. [3]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [3]
- Study design
-
Controlled observational. [3]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [3]
- Measurement
-
Screen-detected cancers within 3 months, by reader combination. [3]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [3]
- Setting and sample
-
55,581 women aged 40 to 74 screened at Capio Sankt Göran Hospital, 1 April 2021 to 9 June 2022. [3]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [3]
- Measures
-
Screen-detected breast cancers. [3]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [3]
- Comparison
-
Double reading by two radiologists. [3]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [3]
- Results
-
269 vs 250 cancers with AI as third reader (relative proportion 1.08); 261 vs 250 for one radiologist plus AI. [3]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [3]
- Additional value from AI
-
19 additional cancers. [3]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [3]
- Limitations
-
One hospital, one AI product, one mammography vendor; interval cancers not yet reported; Lunit co-funded the study. [3]
Fully reviewed: supporting details for Limitations
Review date: 29 October 2026.
Sources: [3]
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: Lunit. Operator: Capio Sankt Göran Hospital with Karolinska Institutet (ScreenTrustCAD study).
Awaiting review
- Jurisdictions
-
Benefit: Stockholm,
Sweden. Developer: 
South Korea. 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
-
A consensus step must exist where AI-flagged cases are reviewed by radiologists. The AI threshold must be set to match radiologist sensitivity on local data. The AI must perform on the local equipment as it did on Philips mammography units.
Awaiting review
- Replication attempts
-
2 follow-up entries. Benefit recurred: 2.
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-0643-source-0001–0004
Awaiting review
- Citations
-
Numbered references below.
Awaiting review
- Language
-
Unresolved
Not reviewedUnresolved
- Source relationships
-
Independent, Developer
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: two independent peer-reviewed studies and two peer-reviewed studies from the makers. The cited evidence includes no finding by a regulator or court. [1] [2] [3] [4]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
People.
Awaiting review
- Depth
-
People: 4.
Awaiting review
- Reasons
-
People: Nineteen women had breast cancer found at screening only because the AI flagged their examinations (269 cancers with AI against 250 without).
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 prospective paired-reader non-inferiority 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
-
Insight MMG was built to detect breast cancer on mammograms. In ScreenTrustCAD it served as an independent reader; the extra cancers found were that purpose.
Awaiting review
- Dates
-
Observed: 9 June 2022. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was used in a pilot. A prospective clinical study at one hospital within population screening. [1]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 1b00fd8af556…
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
-
Peer-reviewed study Independent author
Dembrower 2023 AI + R1 + R2 (triple) 4.84 / 4.50 p < 0.0001
-
Peer-reviewed study Independent author
MASAI (randomized AI-supported risk triage within a national program), ScreenTrustCAD (prospective paired-reader evaluation with AI as an independent reader in a double-reading framework), and PRAIM (nationwide decision-referral implementation)
-
Peer-reviewed study Developer
Dembrower K, Crippa A, Colón E, Eklund M, Strand F; ScreenTrustCAD Trial Consortium. Artificial intelligence for breast cancer detection in screening mammography in Sweden: a prospective, population-based, paired-reader, non-inferiority study. Lancet Digit Health. 2023;5(10):e703-e711. doi:10.1016/S2589-7500(23)00153-X
triple reading by two radiologists plus AI (269 [0·5%] vs 250 [0·4%] detected cases; relative proportion 1·08 [1·04-1·11]) were also non-inferior to double reading by two radiologists
-
Peer-reviewed study Developer
Dembrower K, et al. Lancet Digit Health. 2023. Full text (archived copy)
For the reading by AI, the Insight MMG AI system (version 1.1.6; Lunit, Seoul, South Korea) 4 was used