EarliPoint Assessment

The EarliPoint Assessment is an eye-tracking device that aids qualified clinicians in diagnosing Autism Spectrum Disorder (ASD) in children ages 16 months through 95 months (7 years) who are at risk based on parental, caregiver, or healthcare provider concerns. The device measures a child's looking behavior while viewing age-appropriate videos, then uses software to analyze the data and output an ASD diagnosis along with three developmental delay indices.

The subject device has identical technological characteristics to the predicate (EarliPoint System K243891), consisting of an eye-tracking module, operator module, and WebPortal for data analysis. The key difference is that the subject device outputs three diagnostic labels (positive, negative, and borderline) versus only positive and negative for the predicate, which does not adversely affect safety or effectiveness.

IEC 60601-1:2005/AMD1:2012/AMD2:2020 (electrical safety); IEC 60601-1-2:2014/AMD1:2020 (electromagnetic compatibility); ISO 13485 (quality management); ISO 62304 (software development); IEC 62304 (software design and testing).

Both devices share the same intended use (ASD diagnosis aid in pediatric patients), indications for use structure, prescription use classification, product code (QPF), and technological characteristics. The subject device expands the approved age range from 16–30 months to 16–95 months; clinical studies in the expanded age range demonstrated substantially equivalent sensitivity (80.2%) and specificity (81.3%) compared to the predicate, with no serious adverse events, establishing that the expanded age range raises no new safety or effectiveness concerns.