Work

Beyond transparency: equity readiness of FDA-authorized AI/ML-enabled medical devices

Year: 2026

Type: preprint

Abstract: Cross-sectional audit of equity readiness across all FDA-authorized AI/ML-enabled medical devices (n=1,428, cutoff 30 Dec 2025). Introduces the Equity Readiness Assessment (ERA), a 19-item instrument across four domains, measuring not only demographic transparency but population-data alignment between training/validation cohorts and the populations most burdened by each device's target condition. LLM-assisted extraction (Claude Sonnet 4.6) validated by dual independent human review of a stratified n=153 sub-sample (census of 37 De Novo + 16 PMA + stratified random n=100 510(k); RNG seed 20260430). Target: Communications Health (Nature Portfolio), Digital Health and Health Equity collection.

DOI: 10.17605/osf.io/qsgmv

Authors: Purkayastha, Saptarshi, Aravind V. Kuruvikkattil, Chaitra Sammeta, Aiswarya N. Perumbilly, Rashmita Kudamala, Gichoya, Judy W.

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDGs: Good health and well-being, Reduced inequalities

Open Access status: green

OpenAlex ID: W7162550265

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