Benefits
- Benefit
-
An observed sensitivity of 87.4%
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Accessibility
Awaiting review
- Status
-
Reported benefit
Awaiting review
- Beneficiary groups
-
Organizations. Society.
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
-
IDx-DR
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
-
Previously untrained camera operators took four retinal photographs with a Topcon NW400 camera after standardized training. The software graded the images without a physician. Some participants needed pupil dilation to obtain usable images.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The trial measured the accuracy of the software against a reading center. It had no comparison arm of usual screening, so the gain over usual care is not isolated.
Awaiting review
- AI contribution
-
Unresolved
Not reviewedUnresolved
Measurement
- Studies
-
Other. [2]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [2]
- Study design
-
Other. [2]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [2]
- Measurement
-
Prospective diagnostic accuracy study against reading center grading of fundus photographs and OCT. [2]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [2]
- Setting and sample
-
900 adults with diabetes enrolled at 10 US primary care sites; 819 fully analyzable. [2]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [2]
- Measures
-
Sensitivity and specificity for more than mild diabetic retinopathy. [2]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [2]
- Comparison
-
Reading center reference standard and pre-specified goals. [2]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [2]
- Results
-
Sensitivity 87.4%, specificity 89.5%, imageability 96.1%. [2]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [2]
- Additional value from AI
-
Not isolated; the software is the whole screening test. [2]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [2]
- Limitations
-
No usual-care comparison arm; 73 participants could not be fully analyzed; vision outcomes not measured. [2]
Fully reviewed: supporting details for Limitations
Review date: 29 October 2026.
Sources: [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: IDx, LLC. Operator: Ten primary care sites in the IDx-DR pivotal trial.
Awaiting review
- Jurisdictions
-
Benefit: Ten primary care 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 has diabetes and no earlier diagnosis of diabetic retinopathy. The images meet the quality standard of the software. Patients with a positive result are referred to an eye care professional.
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-0621-source-0001–0002
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
-
Found by a regulator. Sources: one independent regulatory document and the makers' peer-reviewed study. The cited evidence includes no independent study or report. [1] [2]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
Organizations. Society.
Awaiting review
- Depth
-
Organizations: 2. Society: Not assessed.
Awaiting review
- Reasons
-
Organizations: Camera operators with no earlier imaging experience obtained a screening result for 96.1% of graded participants, and the software found 87.4% of people with more than mild retinopathy. Society: FDA reviewers describe wider access to retinopathy screening in primary care as a potential benefit, and no realized effect on access or vision across the population is reported.
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 diagnostic accuracy trial. [2]
Fully reviewed: supporting details for Kind
Review date: 29 October 2026.
Sources: [2]
- 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
-
IDx-DR was built to detect more than mild diabetic retinopathy in primary care without a physician reading the images. The measured benefit is that purpose.
Awaiting review
- Dates
-
Observed: July 2017. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was used in a pilot. A prospective pivotal trial in working primary care clinics before marketing authorization. [2]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [2]
- Version
-
SHA-256: cd73c40c3e33…
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
-
Peer-reviewed study Developer
Abramoff MD, Lavin PT, Birch M, Shah N, Folk JC. Pivotal trial of an autonomous AI-based diagnostic system for detection of diabetic retinopathy in primary care offices. npj Digital Medicine 2018;1:39.
The AI system exceeded all pre-specified superiority endpoints at sensitivity of 87.2% (95% CI, 81.8-91.2%) (>85%), specificity of 90.7% (95% CI, 88.3-92.7%) (>82.5%), and imageability rate of 96.1% (95% CI, 94.6-97.3%)
-
Regulatory document Independent author
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for IDx-DR (DEN180001): decision summary. Granted 2018-04-11.
The pivotal clinical study, which enrolled a total of 900 participants, demonstrated observed sensitivity for mtmDR 87.4%, with observed specificity of 89.5%.