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The EarliPoint System device is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months, who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.

The EarliPoint system uses an eye tracker to capture the patient's looking behavior while viewing a series of videos. The system then remotely analyzes the looking behavior data using software and outputs a diagnosis of the patient's ASD status and associated developmental delay indicies. The EarliPoint System device consists of the following: • Eye-tracking module and a separate Operator Module that can control the Eye-tracking module remotely. The patient sits on a chair and the Eye-tracking module is adjusted by the operator such that the patient's eyes are within the specification of the eye tracking window. • Eye-tracking module captures the patient visual response to social information provided in the form of a series of age-appropriate videos. • Operator's module is used to initiate and monitors the session remotely • WebPortal securely stores all patient information, analyzes the eye tracking data, and outputs the results. Users can retrieve the results directly from the web-portal. • Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 developmental delay indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments Social Disability Index correlates and proxies ADOS-2 Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score

The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of ASD patients ages 16 months through 30 months.

The device is a more compact version of the predicate device but otherwise has similar functions and features. The system uses an eye tracker to capture the patient's looking behavior while viewing a series of videos. The system then remotely analyzes the looking behavior data using software and outputs a diagnosis of the patient's ASD status and assesses the symptoms associated with ASD. The system has two modules: EarliPoint System consists of the following: - Eye-tracking module and a separate Operator Module that can control the Eye-tracking module remotely. The patient sits on a chair and the Eye-tracking module is adjusted by the operator such that the patient's eyes are within the specification of the eye tracking window - -Eye-tracking module captures the patient visual response to social information provided in the form of a series of age-appropriate videos - Operator's module is used to initiate and monitors the session remotely - - -WebPortal securely stores all patient information, analyzes the eye tracking data, and outputs the results. Users can retrieve the results directly from the web-portal. - -Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. In addition, it also outputs 3 indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments - o Social Disability Index correlates and proxies ADOS-2 - O Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score - O Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score The eye-tracker used in the EarliPoint device has similar capability as the eye tracker used in the predicate device.

The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) for patients ages 16 months through 30 months.

The EarliPoint System is a medical device for diagnosis of Autism Spectrum Disorder (ASD) in children. EarliPoint System consists of the following: - EarliPoint WebPortal to enter the patient information and for access to the patient evaluation results, - EarliPoint Device with eye-tracking capability captures the patient visual response to social information provided in the form of a series of age-appropriate videos - Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. - Eye-tracking data also outputs 3 indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments - Social Disability Index correlates and proxies ADOS-2 - Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score - Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score