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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

The EarliPoint System, a device for diagnosing Autism Spectrum Disorder (ASD), underwent a pivotal study to demonstrate its safety and effectiveness.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" but rather shows the device's performance (sensitivity and specificity) relative to a predicate device (CanvasDx) and a "gold standard" expert clinical diagnosis. The implication is that meeting or exceeding the predicate's performance, especially for certain populations, was a key aspect of acceptance.

Note: The document states: "When compared to the predicate. CanvasDx, the sensitivity and specificity of the EarliPoint device are higher than the CanvasDx and hence the two devices are substantially equivalent." This implies that outperforming the predicate was a key acceptance criterion.

2. Sample Size and Data Provenance

• Test Set Sample Size: 475 evaluable patients for primary and secondary endpoint analysis (from an initial enrollment of 500).
• Data Provenance: The study was "multi-center" with data collected from "six sites in the United States." The study was "prospective."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated, but the ground truth was established by "expert clinicians" at "six sites." The document refers to "expert clinician diagnosis" and "clinicians' reference diagnoses."
• Qualifications of Experts: Described as "expert clinician diagnosis (current best practice for diagnosis of ASD)." Specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for conflicting expert opinions. It refers to a "gold standard of the expert clinician diagnosis." It does, however, categorize the ground truth into "Certain Dx Population" (clinicians' certainty rating > 80%) and "Uncertain Dx Population" (clinicians' certainty rating ≤ 80%), indicating some level of consideration for diagnostic confidence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was explicitly mentioned in the provided text, comparing human readers with AI assistance vs. without AI assistance. The study focuses on the device's performance compared to human expert diagnosis as the ground truth. The device is intended as an "aid clinicians," suggesting a human-in-the-loop scenario, but a specific MRMC study design is not detailed.

6. Standalone (Algorithm Only) Performance

• The reported sensitivity and specificity values represent the standalone performance of the EarliPoint System's algorithm in diagnosing ASD, as it provides a "diagnosis for ASD" from analyzing eye-tracking data. The study "evaluated for ASD by both the EarliPoint system and by expert clinician diagnosis."

7. Type of Ground Truth Used

• The primary ground truth used was "expert clinician diagnosis (current best practice for diagnosis of ASD)."
• Additionally, the study correlated the three EarliPoint Severity Indices (Social Disability, Verbal Ability, Non-verbal Ability) against corresponding "expert clinical instruments of ADOS-2 and Mullen." This indicates a reliance on established clinical diagnostic tools as part of the expert ground truth.

8. Sample Size for the Training Set

• The document does not provide the sample size used for the training set. It only describes the design and results of the pivotal clinical study (test set).

9. How the Ground Truth for the Training Set was Established

• The document does not provide information on how the ground truth for the training set was established. It focuses solely on the test set's ground truth.

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