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ImPACT is intended for use as a computer-based neurocogntive test battery to aid in the assessment and management of concussion.

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery that allows healthcare professionals to conduct a series of tests on individuals to gather data related to the neurocognitive functioning of the test subject. This test battery measures various aspects of neurocognitive functioning including reaction time, memory, attention, spatial processing speed, and records symptoms of a test subject. ImPACT Version 4 is similar to the paper-and-pencil neuropsychological tests that have long been used by psychologists to evaluate cognition, and memory related to a wide variety of disabilities.

The device is not intended to provide a direct diagnosis or a return-to-activity recommendation, it does not directly manage or provide any treatment recommendations, and any interpretation of the results should be made only by qualified healthcare professional. The neurocognitive assessment represents only one aspect of assisting healthcare professionals in evaluating and managing individuals with cognitive function impairment related to TBI (concussion).

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ImPACT Version 4, K202485) rather than explicitly listing quantitative acceptance criteria for each neurocognitive measure. However, the core of the performance demonstration rests on the establishment of a normative database for iPad use and test-retest reliability consistent with previous versions.

Implied Acceptance Criteria and Performance:

Detailed Study Information:

1. Sample Size and Data Provenance:

   • Test Set (Normative Data):
     • Sample Size: 1495 subjects.
     • Data Provenance: Prospectively collected from 4 different sites across the US in 2022 and 2023.
     • Type: Prospective.
   • Test Set (Test-retest Reliability):
     • Sample Size: 116 individuals, a subset of the normative sample.
     • Data Provenance: Prospectively collected from the same US sites as the normative data, in 2022 and 2023.
     • Type: Prospective.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense of a diagnostic consensus.
   • For the normative and test-retest studies, the "ground truth" is primarily based on the self-reported health status of the participants (e.g., "not suffering from a concussion or being treated for a concussion in the past 6 months," "no known physical, neurological, behavioral or psychological impairment"). The inclusion criteria, which participants had to meet, effectively defined the "healthy" or "normal" population against which the device's performance is normed.
   • Clinical experts were part of the "cross-functional team" involved in "Walkthroughs and design reviews of mock-ups and prototypes" during software verification, but not explicitly for ground truth establishment for the clinical study data itself.

3. Adjudication Method for the Test Set:

   • The document does not describe an adjudication method for the clinical study data. The studies focused on collecting representative data from healthy individuals to establish norms and assess reliability, rather than evaluating the device's diagnostic accuracy against a separate, adjudicated clinical diagnosis.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not performed. This device is a neurocognitive test battery, not an imaging AI diagnostic aid meant to be used by multiple readers on the same cases. The "human-in-the-loop" aspect is not about human readers interpreting AI output, but rather healthcare professionals using the device's objective measures to aid in assessment and management.

5. Standalone Performance:

   • The device ImPACT is a "computer-based neurocognitive test battery." The performance described (normative data collection, test-retest reliability) is inherently the "algorithm only" performance, where the "algorithm" refers to the test battery itself and its scoring methodology. The device provides "objective measure of neurocognitive functioning," which is its standalone output. The interpretation of these results is then done by a qualified healthcare professional.
   • So, yes, a standalone performance assessment was done in the form of normative data collection and test-retest reliability, demonstrating the device's intrinsic ability to measure cognitive function consistently in an uninjured population.

6. Type of Ground Truth Used:

   • The primary ground truth for the normative database was the self-reported clinical status and inclusion/exclusion criteria of the participants, aiming for a "healthy" or "uninjured" cognitive state. This serves as the reference for "normal" cognitive functioning.
   • For the test-retest reliability, the implicit ground truth is that the cognitive state of the healthy individuals should not have changed significantly between the two tests, allowing for an evaluation of the device's consistency.

7. Sample Size for the Training Set:

   • The document does not explicitly describe a separate "training set" for an AI or machine learning model in the context of this 510(k) submission.
   • The term "normative database" sometimes functions similarly to a reference or training set in that it establishes what "normal" looks like. In this case, the 1495 subjects for the normative database building represent the data used to define the expected range of performance.
   • The "training" of the neurocognitive test itself, being a standardized battery, is more akin to its initial development and validation stages prior to the specific modifications addressed in this 510(k). The current submission focuses on adapting an existing, validated test to a new platform (iPad) and updating its normative reference.

8. How the Ground Truth for the Training Set Was Established:

   • As mentioned above, if the normative database is considered the "training set" for defining normal performance, its "ground truth" was established by prospectively enrolling individuals who met strict inclusion criteria indicating they were healthy, English-speaking, not suffering from or recently treated for a concussion, and without other known neurological/physical impairments that would affect test performance. This was overseen by ethics boards and involved multiple US sites.

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