Validation Study of RETINA-AI Galaxy™ v2.0, an Automated Diabetic Retinopathy Screening Device

This study was a prospective, multicenter, observational study to assess the safety and efficacy of the RETINA-AI Galaxy™ v2.0 ("Galaxy™") in screening for diabetic retinopathy in the primary care setting. The study design conformed to an Intent to Screen (ITS) paradigm. The Galaxy™ is a Software-as-a-Medical-Device designed to analyze digital color fundus photographs and rapidly screen for diabetic retinopathy in the primary care setting.

Subjects who met eligibility criteria were recruited from Sites in the United States staffed by primary care providers. Eligibility was assessed and informed consent was obtained, after which digital color fundus photographs were taken using U.S. Food and Drug Administration (FDA) cleared non-mydriatic fundus cameras, by an operator using the Galaxy photography manual.

There were a total of 3 non-mydriatic robotic screening cameras used in the AI system protocol part of the study. There was a dedicated validation camera used in the Validation Reading Center Protocol part of the study at each Site. Primary care clinical staff (e.g. medical assistant) with no prior professional ophthalmic photography experience and only a 4 hour training operated the RETINA-AI Galaxy v2.0 device and the screening cameras. The Retina Reading Center (RRC)- certified professional ophthalmic photographers operated the validation fundus cameras according the the 4W-D stereo protocol, and obtained OCT images of the macula.

Inclusion criteria

• Patient age 22 or above
• Patient with a documented diagnosis of diabetes as defined by any of the following:

A. Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments B. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments C. Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.

D. Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L) E. Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).

• Understanding of the Study and willingness and ability to sign informed consent

Exclusion criteria

• Persistent vision loss in one or both eyes
• Diagnosis with macular edema, severe non-proliferative diabetic retinopathy, proliferative diabetic retinopathy, radiation retinopathy, or retinal vein occlusion.
• History of retinal laser treatment, or injections into either eye, or any history of retinal surgery.
• Currently enrolled in another interventional study of an investigational device or drug and actively receiving an investigational product for diabetic retinopathy (DR) or Diabetic Macula Edema (DME).
• Subject has contraindication to mydriatic agent (dilating drops) or is unwilling or unable to dilate.
• Subject is contraindicated from fundus photography (e.g. subject is hypersensitive to light).