Medical AI Evaluation

We aggregate 141 FDA approved AI devices and report how each device was evaluated.

Device Database

approval_number	device_name	classification_product_code	date_received	decision_date	indications_for_use	body_area	modality	predicate_numbers	sample_size	num_sites	inc_exc_criteria	has_demographics	is_prospective	subtype_analysis	significance	severity	risk_level	keywords	summary_link

Visualizations

Device Summaries

Device Name:
Approval Number:
Decision Date:
Indications for Use:
Body Area:
Modality:
Sample Size:
Number of Sites:
Risk Level:
Has Inclusion/Exclusion Criteria?:
Has Demographic Data?:
Has a Prospective Study?:
Has Subtype Analysis?:

Methodology Notes

Evaluation feature details:

Note: The data collected for the database is based only on publicly available information from FDA.gov.
Sample_size: Some reports contain multiple sub-studies with different sample sizes. In these cases, we report only the maximum sample size across sub-studies.
Risk_level: Refers to the overall importance of the device toward treatment of a disease. The four tiers are based on IMDRF guidelines detailed here.
Is_prospective: Prospective studies are defined as clinical studies in which the data is collected concurrently with device deployment.
We report 'NA' values when the summary report does not contain information regarding the feature.

Version changes:

04/23/21: Added 11 additional 510(k) devices, and updated DEN180001.