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The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computerbased neurocognitive test batteries to aid in the assessment of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.

The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.

The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance in populations, to aid in the assessment and management of concussion. ANAM measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.

The software is downloaded from the Vista LifeSciences website and is for use on Dell Inspiron 15 3000 Series or similar Windows PC model or Android Samsung Galaxy tablet or similar Android device. The hardware 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.

Specific modules included in the ANAM Test System:

• 1. Questionnaires
  • 1. Demographics
  • 2. Mood Scale
  • 3. Neurobehavioral Symptom Inventory (NSI)
  • 4. PTSD Checklist (PCL)
  • 5. Sleepiness Scale
  • 6. Symptoms Checklist
  • 7. TBI Questionnaire

Performance Tests

• 8. Code Substitution Learning
• 9. Code Substitution Delayed
• 10. Go/No-Go"
• 11. Matching to Sample*
• 12. Mathematical Processing
• 13. Memory Search
• 14. Procedural Reaction Time
• 15. Simple Reaction Time*
• 16. Spatial Processing*
• *Available for tablet platform.

The tests and questionnaires can be combined into custom batteries or users can choose from pre-configured standardized batteries. The standardized batteries include ANAM Core, ANAM Sports. ANAM Military, and ANAM Military-Expanded. These standardized batteries have fixed test settings and parameters to ensure standardized presentation and enable comparison to normative data.

Here's a breakdown of the requested information regarding the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ANAM Test System.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the full study methodology in the way a clinical study report would. Therefore, some information, particularly regarding specific acceptance criteria values, sample sizes for test and training sets, number and qualification of experts, adjudication methods, and MRMC study specifics, is not explicitly stated in this document. The document primarily highlights the "numerous studies" that have examined concurrent validity.

Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantially equivalent performance to the predicate device, ImPACT, in providing an objective measure of neurocognitive functioning to aid in the assessment and management of mild traumatic brain injury (mTBI).

Study Proving Device Meets Acceptance Criteria

The document states that the substantial equivalence determination is based on "numerous studies" that have examined the concurrent validity of ANAM.

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for specific test sets within this summary. It mentions "numerous studies" with "normal and concussed populations."
   • Data Provenance: Not specified (e.g., country of origin). The document implies the studies are part of the broader clinical evidence for the device. The studies examined "concurrent validity" by correlating ANAM with "traditional neuropsychological tests." This suggests retrospective or prospective clinical data involving real patient populations.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified within the 510(k) summary. The ground truth for "concurrent validity" studies would typically involve the results from the "traditional neuropsychological tests" administered by qualified neuropsychologists or clinicians.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified. The studies focused on "concurrent validity" which suggests a comparison to established, validated neuropsychological tests rather than an adjudication process between human readers for diagnostic consensus.

4. 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:

   • Not applicable/Not mentioned. The ANAM Test System is described as a "computer-based neurocognitive test battery" and a "software only device." It functions as an adjunctive tool to aid healthcare professionals in assessment and management. This type of device typically provides quantitative measures of cognitive function directly, rather than assisting human 'readers' in interpreting medical images or complex data in an MRMC study setup. The studies focus on the validity of the test itself in measuring cognitive function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The "performance data" section (p. 5) discusses the results of studies examining the "concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests." This refers to the standalone performance of the ANAM test in measuring cognitive function and its correlation with established measures, without direct human-in-the-loop assistance for interpreting the ANAM results, though a human clinician ultimately uses the results in their assessment.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth relies on the scores and results derived from "traditional neuropsychological tests" administered to "normal and concussed populations." This implies that expert diagnosis of concussion and the established measurements from these traditional gold-standard tests served as the reference for determining concurrent validity.

7. The sample size for the training set:

   • Not specified in the 510(k) summary. Given that it's a "computer-based neurocognitive test battery" and not a typical AI/ML algorithm that requires a discrete training dataset in the same way, any "training" would likely refer to the iterative development and validation of the test components and norming data based on large population studies, rather than a separate "training set" for an explicit AI model. The document mentions "normative data" and a "normative database."

8. How the ground truth for the training set was established:

   • For the establishment of "normative data" (which would serve a similar function to a training set for a traditional AI model), the ground truth would be established through the collection of ANAM test performance data from large, healthy populations across different demographics, age groups, and potentially educational levels. This process involves statistical analysis to define "normal" ranges and establish a reliable baseline against which individual performance can be compared. The summary mentions "standard scores (calculated with the normative database)" and "the summed T-score of a normative control group."

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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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