Benefits
- Benefit
-
A positive predictive value of 81%
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Intended. Clinicians in the study were blinded to the device output, so the measured accuracy changed no diagnosis and the sources report no realized benefit. [2]
Fully reviewed: supporting details for Status
Review date: 29 October 2026.
Sources: [2]
- 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
-
Cognoa ASD Diagnosis Aid
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
-
Caregivers answered a questionnaire and recorded home videos through a smartphone app. Trained analysts rated the videos and a clinician completed a questionnaire.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The study compared the device output with a specialist reference diagnosis. It did not compare diagnosis with and without the device.
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 double-blinded single-arm diagnostic accuracy study against a DSM-5 specialist reference standard. [2]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [2]
- Setting and sample
-
711 enrolled, 425 completers at 14 US sites. [2]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [2]
- Measures
-
PPV, NPV, sensitivity, specificity, no-result rate. [2]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [2]
- Comparison
-
Specialist reference diagnosis. [2]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [2]
- Results
-
PPV 81%, NPV 98%, sensitivity 98%, specificity 79%; no result for 68%. [2]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [2]
- Additional value from AI
-
Not isolated. [2]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [2]
- Limitations
-
No result for 68% of children; high dropout; outputs blinded so care was unchanged. [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: Cognoa, Inc. Operator: Fourteen US sites in the Cognoa ASD Diagnosis Aid validation study.
Awaiting review
- Jurisdictions
-
Benefit: Fourteen 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 child is 18 to 72 months old with a developmental concern. The clinician uses the result with other clinical evidence.
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-0629-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.
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 device output was hidden from the clinicians, so no site gained a diagnosis that it would otherwise have missed or delayed.
Awaiting review
- Observed or intended
-
Intended. Clinicians in the study were blinded to the device output, so the measured accuracy changed no diagnosis and the sources report no realized benefit. [2]
Fully reviewed: supporting details for Observed or intended
Review date: 29 October 2026.
Sources: [2]
- 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 study. [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
-
The Cognoa ASD Diagnosis Aid was built to help healthcare providers diagnose autism spectrum disorder in young children. The measured accuracy is that purpose.
Awaiting review
- Dates
-
Observed: June 2020. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was used in a pilot. A prospective validation study at 14 sites before authorization; outputs were blinded. [2]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [2]
- Version
-
SHA-256: 7858907b682a…
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
Megerian JT, Dey S, Melmed RD, et al. Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder. npj Digital Medicine 2022;5:57.
The Device yielded these ASD positive or negative results with a PPV of 80.8% (95% CI, 70.3%-88.8%), NPV of 98.3% (95% CI, 90.6%-100%), sensitivity of 98.4% (95% CI, 91.6%-100%), and specificity of 78.9% (95% CI, 67.6%-87.7%).
-
Regulatory document Independent author
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Cognoa ASD Diagnosis Aid (DEN200069): decision summary. Granted 2021-06-02.
Currently, the average age of diagnosis for ASD in the United States is 4.3 years, as compared to 2.8 years observed in the pivotal trial of the Cognoa ASD Diagnosis Aid.