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The EarliPoint Assessment 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 95 months (7 years), who are at risk based on concerns identified by a parent, caregiver, or healthcare provider.

The EarliPoint assessment uses an eye tracker to measure 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 indices.

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.
• 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 validated ASD instruments

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for the EarliPoint Assessment device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance of the predicate device and the new clinical study for the expanded age range. The primary metrics are Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), and Accuracy, compared to the expert clinical diagnosis (reference standard). The "Comparison" column in the provided table states "Substantially Equivalent" for all metrics, indicating that the performance of the subject device in the expanded age range (and the combined age range) meets the implicit acceptance criteria based on its predicate.

Note: The predicate values for the 16-30 month age range, when reanalyzed with the borderline range, showed slightly different (and in the case of sensitivity, higher) performance. The performance of the subject device across the combined age range appears to maintain substantial equivalence. The document explicitly states, "clinical data from the expanded age range demonstrates the safety and effectiveness of the device without raising new or different questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Sizes:
  • 16-30 months (original study): The table "EarliPoint System 16-30 months" shows a total of 335 participants for the predicate device. For the subject device (with borderline range implemented), the performance figures are based on 307 participants after excluding borderline cases from sensitivity/specificity calculations.
  • 31 to <96 months (new study): The table "EarliPoint System 31 to <96 months" shows performance figures based on 369 participants (when borderline cases are excluded). Initial count for the entire population was 477 (when borderline was considered ASD-negative).
  • Combined 16 to <96 months: A total of 676 participants (when borderline cases are excluded). Initial count for the entire population was 812 (when borderline was considered ASD-negative).
• Data Provenance: The studies were prospective, double-blind, multi-center, within-subject comparison, US, pivotal studies. This means the data was collected specifically for this evaluation, from multiple centers within the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document states:

• "All patients were evaluated for ASD by ... expert clinician diagnosis (current best practice for diagnosis of ASD)."
• "robust convergent validity in comparison with Reference Standard assessments of social disability, verbal ability, and nonverbal cognitive ability made by highly trained experts at leading expert centers."

The exact number of experts is not specified. Their qualifications are described as "expert clinician" and "highly trained experts at leading expert centers," implying specialized training and experience in ASD diagnosis, likely including child psychiatrists, developmental pediatricians, or licensed psychologists with expertise in ASD.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1). However, it highlights the challenge of "clinical uncertainty" in ASD diagnosis, noting that even clinicians are sometimes less than fully certain of their diagnoses. It states: "EarliPoint clinical trial procedures worked effectively to reduce and minimize, to the extent possible, clinician uncertainty in the reference standard diagnosis." This suggests that efforts were made to achieve a high degree of confidence in the ground truth, but the specific process (e.g., multiple independent diagnoses followed by a consensus meeting or a tie-breaker by a more senior expert) is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The study described is a standalone (algorithm only) performance study, comparing the device's output directly against expert clinical diagnosis (reference standard). It is not an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is measured. Therefore, there is no information provided about the effect size of human readers improving with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

Yes, a standalone study was done. The entire premise of the clinical study is to evaluate the "EyeTracking System diagnosis relative to the expert clinical diagnosis" and quantify its sensitivity, specificity, and other metrics. The device "outputs a diagnosis of the patient's ASD status," implying a direct algorithmic output without human intervention for the primary outcome.

7. The Type of Ground Truth Used

The primary ground truth used is expert clinician diagnosis, specifically described as "current best practice for diagnosis of ASD." This diagnosis also includes assessments using "validated ASD instruments" like ADOS-2, and Mullen/DAS-II, as referenced for correlating the EarliPoint Severity Indices.

8. The Sample Size for the Training Set

The document does not provide any information regarding the size or characteristics of the training set used to develop the EarliPoint Assessment algorithm. The clinical studies described are for validation/testing of the device's performance, not for its training.

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

Since information on the training set's sample size is not provided, the method for establishing its ground truth is also not specified in this document.

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