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The ANAM Test System: Military Battery provides clinicians with objective measurements of cognitive performance in military populations ages 18 to 65 years, to aid in the assessment of an individual's level of cognitive functioning. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.

ANAM Test System: Military Battery is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The software is downloaded from the Vista LifeSciences website and is for use on a Dell Latitude E6440 Laptop. The laptop is not provided as part of the device, but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.

The ANAM Test System: Military Battery is a software-only device designed to provide objective measurements of cognitive performance in military populations (ages 18 to 65 years) as an adjunctive tool for evaluating cognitive function.

Here's an analysis of the provided information regarding its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal acceptance criteria with numerical thresholds. Instead, the "Performance Data" section discusses the general demonstration of concurrent validity with traditional neuropsychological tests. The "Summary / Conclusion of Substantial Equivalence Rationale" further states that "ANAM provides a reliable measure of cognitive function."

To present this in a tabular format based on the given information:

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

The document states, "The 510(k) included the results of numerous studies that examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests."

• Sample Size: The exact sample size for the test set(s) is not specified. The mention of "numerous studies" suggests multiple datasets were used, but no specific numbers are given.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. The target population is "military populations ages 18 to 65 years," suggesting the data would likely be from military personnel.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The ground truth appears to be derived from "traditional neuropsychological tests," implying that the interpretation of these tests by qualified neuropsychologists or clinicians would form the reference standard, but this is not explicitly stated or detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set. Since the "performance data" describes correlations with traditional neuropsychological tests, it's likely that the results of these established tests served as the reference, rather than a separate adjudication process of the ANAM results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. The evaluation focused on the device's standalone performance in correlation with traditional neuropsychological tests to establish substantial equivalence, not on how human readers' performance improves with or without AI assistance.

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

Yes, a standalone performance evaluation was done. The "Performance Data" section describes "the results of numerous studies that examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests." This implies that the device's output (scores) was directly compared or correlated with the output of established cognitive tests, operating as a standalone algorithm. The device "provides clinicians with objective measurements," and "ANAM does not provide a recommendation that the patient is impaired vs. unimpaired. Clinical interpretation... includes comparison with the normative database." This further reinforces its role as a standalone measurement tool.

7. The Type of Ground Truth Used

The ground truth used appears to be the results or scores from "traditional neuropsychological tests." The studies aimed to establish "concurrent validity" by showing correlations between ANAM's measurements and these established tests, which serve as the accepted standard for assessing cognitive function.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It focuses on the validation studies that demonstrate concurrent validity with established tests. The device utilizes a "military normative database" for interpreting results, but the size or development of this database is not detailed regarding "training."

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

The document does not provide information on how the ground truth for any training set was established. The focus is on the validation of the ANAM system by correlating its output with "traditional neuropsychological tests." If a "military normative database" was used for training or calibration, the method for establishing its ground truth (e.g., through large-scale testing of healthy military populations by neuropsychologists) is not described.

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