Precision Study of CLAiR AI Software

This prospective, multi-site precision study was designed to evaluate the analytical performance and reproducibility of the CLAiR AI software, a software as a medical device (SaMD) intended to identify individuals with elevated risk of atherosclerotic cardiovascular disease (ASCVD) using retinal fundus images.

Participants were enrolled at U.S. clinical sites and underwent protocol-defined retinal imaging procedures using Topcon NW400 and NW500 non-mydriatic fundus cameras. Imaging was performed under controlled conditions, including predefined operator sequencing and repeated image acquisition, to assess reproducibility across operators and devices.

The primary objective was to evaluate agreement of device outputs across repeated imaging sessions and camera models. Secondary objectives included assessment of intra- and inter-operator variability.

The device under investigation was not FDA cleared or approved at the time of the study and was evaluated under institutional review board (IRB) oversight as a non-significant risk (NSR) device study. No therapeutic interventions were administered, and no clinical management decisions were made based on device outputs.

Inclusion criteria

Previously participated in the CLAiR pivotal study with blood pressure and blood test measurements completed.

Continues to meet the original pivotal study eligibility criteria. Male or female, 40 to 75 years of age. Able and willing to provide written informed consent. Willing and able to comply with all study procedures and complete the single study visit.

Exclusion criteria

Known history of atherosclerotic cardiovascular disease (ASCVD), including stroke, myocardial infarction, coronary artery bypass surgery, or coronary stenting.

Current use of cholesterol-lowering medication (e.g., statins). Pregnancy. Persistent vision impairment in at least one eye (legally blind with current corrective lenses or visual acuity <20/400).

Known pathological myopia in at least one eye. Previous treatment for, or current care by, a retinal specialist for retinal disease in at least one eye.