EarliPoint System

The EarliPoint System is a diagnostic device that uses eye-tracking technology to capture a child's looking behavior while viewing age-appropriate videos. The system analyzes this eye-tracking data using artificial intelligence software to aid qualified clinicians in diagnosing and assessing Autism Spectrum Disorder (ASD) in children ages 16-30 months who are at risk based on parental, caregiver, or healthcare provider concerns.

The device consists of an eye-tracking module that captures visual responses, an operator module to remotely initiate and monitor sessions, a web portal that securely stores patient data and outputs results, and AI software that analyzes eye-tracking data to provide an ASD diagnosis plus three severity indices (Social Disability Index, Verbal Ability Index, Non-verbal Ability Index) that correlate with ADOS-2 and Mullen validated instruments. The subject device is identical in all technological components to the predicate device K230337.

IEC 60601-1:2005/AMD1:2012/AMD2:2020 (electrical safety), IEC 60601-1-2:2014/AMD1:2020 (electromagnetic compatibility), ISO 62304 (software design and testing).

The subject device has identical intended use, indications for use (with clarified wording about patient selection criteria), device components, software algorithm, electrical safety compliance, and clinical safety/effectiveness data as the predicate device K230337. The only change is a clarification to the indications statement specifying that patients should be 'at risk based on concerns identified by a parent, caregiver, or healthcare provider' rather than limiting use to 'specialized developmental disabilities centers.' This clarification does not alter the safety or effectiveness conclusions from the pivotal clinical trial, making the devices substantially equivalent.