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The Sway System Sports Plus is intended for use as a computerized cognitive assessment and management of concussion in individuals ages 18-24. The Sway System Sports Plus is indicated for use when there is a suspected concussion or head injury.

Sway Sports Plus (referred to as Sway Sports+) is a licensed variant of the Device Sway System and is a software solution (SaMD) that provides a computerized cognitive assessment aid for concussion. This prescription device uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to a suspected concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. The examiner may have the patient complete the Sway Balance test to provide an additional indicator in their assessment of concussion. The Sway System is not intended as a stand-alone diagnostic device. After the patient completes the Sway Sports+ test(s), the examiner can view the summary statistics for each test such as mean reaction time (speed). Sway Sports+ does not create new information through analysis or interpretation, nor does it offer any diagnostic or treatment recommendations. The Sway Sports+ is not intended to be used as a standalone diagnostic device. Sway Sports+ operates in the Apple iOS or Android operating systems, enabling it to be used on the hardware of Apple iPhone. iPad, and iPod Touch. or Android mobile devices. The internal accelerometer is accessed to analyze motion of the device in response to stimuli during testing. The mobile device hardware is not provided by Sway Medical. Environments where Sway Sports+ may be used may include both clinical and non-clinical settings. Clinical settings may include physician offices, hospitals, physical or occupational therapy clinics, skilled nursing facilities, assisted living centers and other healthcare facilities where cognitive tests may be evaluated. In addition, non-clinical environments may include sports team's locations where the application may be used on the sideline to perform a cognitive assessment, e.g., fitness centers, gymnasiums, or stadiums. It is recommended that the tests be taken in a supervised environment for baseline and post-injury testing. Sway Sports+ consists of the Sway Balance (K121590) and the Sway Computerized Cognitive Assessment Aid. The Sway Computerized Cognitive Assessment Aid (PTY) is exempt from 510(k).

Here's a breakdown of the acceptance criteria and the study information for the Sway System Sports Plus, based on the provided text:

Acceptance Criteria and Device Performance

The provided text details the non-clinical and clinical performance testing results, and how they relate to the substantial equivalence claim rather than explicit "acceptance criteria" in a pass/fail table format. However, we can infer the acceptance criteria from the reported performance results and the comparison to predicate devices.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

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

ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measures 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 information for the ImPACT Version 4 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission primarily focuses on demonstrating substantial equivalence to a predicate device (ImPACT Version 3.3.0) rather than listing specific, quantitative acceptance criteria for each functional aspect. The document indicates that all software verification and validation tests met the required acceptance criteria, but these criteria are described generally rather than with specific metrics.

However, based on the summary of performance testing and clinical data, the implicit acceptance criteria relate to:

• Software Functionality: The software performs as intended, modifications did not affect existing functionality.
• Safety and Effectiveness: The device modifications do not raise new questions of safety and effectiveness.
• Test-Retest Reliability (for extended age range): Cognitive performance should remain stable over time.
• Construct Validity (for extended age range): ImPACT Version 4 scores should correlate with established neuropsychological tests.
• Normative Database Quality: The normative data should be accurately established for the specified age ranges, differentiating between input device types.

*   For construct validity, the reference standards were scores from other validated neuropsychological tests administered by trained neuropsychologists.

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

• No, the document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study evaluating how human readers (healthcare professionals) improve with ImPACT Version 4 assistance versus without it.
• ImPACT is presented as an "aid" in assessment and management, providing objective measures, but the study design did not assess the human reader's diagnostic performance with and without the device.

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

• Yes, the performance testing described for ImPACT Version 4 is in a standalone capacity. The device itself (the neurocognitive test battery) collects and processes data, and its outputs (scores, validity indicators) are what were evaluated for reliability and validity against other tests or over time. The "performance" being assessed is that of the computerized test generating consistent and correlated results, not a human using the device to make a decision.

7. The Type of Ground Truth Used

• For the normative database: The "ground truth" for subject inclusion was based on self-reported health status (no recent concussion, no neurological issues, no ADHD/LD) and, for the older age group, a basic cognitive screen (MMSE score > 24). The purpose was to establish norms for a healthy population.
• For test-retest reliability: The "ground truth" was the expectation that cognitive performance in a stable individual should not significantly change over a short period.
• For construct validity: The "ground truth" was established by scores from other widely utilized and previously validated traditional neuropsychological tests (HVLT, BVMT-R, SDMT).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning model development. ImPACT is described as a "computer-based neurocognitive test battery" and its modifications primarily involve updating the normative database and output scores, not training a new predictive algorithm.
• The "normative database" could be considered analogous to a reference dataset that the device's scoring relies upon.
  • For ages 12-59: The normative database was constructed from 71,815 subjects.
  • For ages 60-80: The normative database was constructed from 554 subjects.

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

• As mentioned above, there isn't a "training set" for a machine learning model described.
• For the normative databases, which serve as the reference for interpreting individual test results, the "ground truth" for inclusion was:
  • For 12-59 age range: De-identified data selected from a large company database. Subjects had to meet criteria such as no concussion in the past 6 months, no other neurological issues, no ADHD/LD diagnosis. These were self-reported or existing medical history.
  • For 60-80 age range: Prospective data collection where subjects met strict inclusion criteria: ages 60-80, primary English speaking, not in a skilled nursing facility, not suffering from/being treated for a concussion, no known impairing physical/neurological/behavioral/psychological conditions, corrected hearing/vision within normal limits, and a Mini-Mental State Examination (MMSE) score of 24 or greater. This was established through screening and clinical assessment at 8 different sites.

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ImPACT is intended for use as a computer-based neurocognitive 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 12-59.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery.

lmPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual.

lmPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions.

Here's a breakdown of the acceptance criteria and the study details for the ImPACT device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes general claims of conformance and successful verification/validation. The core acceptance criterion for the device modification (allowing unsupervised baseline testing) appears to be that this change does not affect the safety or effectiveness of ImPACT for its intended use, particularly that the number of invalid self-administered tests are not different when compared to the supervised environment.

Study Details

This submission describes changes to an already cleared device, primarily regarding the use environment for baseline testing (allowing unsupervised baseline testing). Therefore, the "study" is focused on demonstrating that this modification does not negatively impact the device's performance or safety.

1. A table of acceptance criteria and the reported device performance: (See table above).

2. Sample size used for the test set and the data provenance:

• Usability/Validity Study: 162 subjects.
  • Composition: 74 college students, 44 Middle and High School students, and 44 adults.
  • Provenance: Not explicitly stated, but implied to be from the US given the FDA submission. It's a prospective study conducted specifically for this device modification.
• Clinical Data (Test-Retest Reliability Study): 50 participants.
  • Provenance: Not explicitly stated, but implied to be from the US. This was a prospective study.

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

• The document does not mention the use of experts to establish ground truth for this specific validation study related to the device modification.
• The clinical study focused on test-retest reliability within individuals performing the ImPACT test. The "truth" here is the individual's own performance consistency, not an external expert's diagnosis.
• The overall ImPACT device, as a "computerized cognitive assessment aid," is designed to provide "objective measures of neurocognitive functioning" that healthcare professionals interpret. The "ground truth" for concussion diagnosis itself relies on a multidisciplinary approach by healthcare professionals, which the device aids in, rather than determines independently.

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

• No adjudication method is described for the test sets. The studies are evaluating the device's output (invalidity rates, reliability scores) directly from participant interactions with the modified device.

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:

• No MRMC comparative effectiveness study was done or described. This submission is for enabling unsupervised baseline testing, not for evaluating human reader performance with or without AI assistance. The device is the assessment aid for healthcare professionals.

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

• Yes, both "studies" implicitly evaluated the standalone performance of the ImPACT device in the context of the proposed unsupervised use environment.
  • The usability assessment determined the rate of invalid tests when self-administered.
  • The clinical data study evaluated the test-retest reliability of the ImPACT scores themselves, independent of human interpretation during the testing phase.
  • The device's output (scores, invalidity indicators) is generated by the algorithm, which is then provided to healthcare professionals.

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

• For the usability/validity study (unsupervised testing): The "ground truth" was internal to the ImPACT system – the device's own "Invalidity Indicator" function was used to determine if results were "invalid." This is based on pre-established criteria within the device, not external expert consensus for each individual test. The comparison was against reported invalidity rates in supervised environments from literature.
• For the test-retest reliability study: The "ground truth" was the consistency of an individual's performance on the test over time. This is assessed statistically using measures like Pearson correlations and Intraclass Correlation Coefficients (ICCs). There is no "ground truth diagnosis" being established here, but rather the reliability of the measurement.

8. The sample size for the training set:

• The document does not provide information on the training set or how the core ImPACT algorithm was initially developed/trained. This submission is for a device modification (change in use environment, minor UI adjustment) of an already cleared predicate device (K170209). The fundamental neurocognitive test battery design and algorithms are stated to be "identical to the original version."

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

• As mentioned above, this information is not provided in this 510(k) summary for the modified device. The document states that the neurocognitive tasks "have been medically accepted as state-of-the-art best practices," implying that the underlying methodology for generating the neurocognitive measures is well-established, but details on the initial training data and ground truth establishment for the original algorithm are absent.

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ImPACT Quick Test is intended for use as a computerized cognitive test aid in the assessment and management of concussion in individuals ages 12-70.

ImPACT Quick Test (ImPACT) QT is a brief computerized neurocognitive test designed to assist trained healthcare professionals in determining a patient's status after a suspected concussion. ImPACT QT provides basic data related to neurocognitive functioning, including working memory, processing speed, reaction time, and symptom recording.

ImPACT QT is designed to be a brief 5-7 minute iPad-based test to aid sideline personnel and first responders in determining if an athlete/individual is in need of further evaluation or is able to immediately return to activity. ImPACT QT is not a substitute for a full neuropsychological evaluation or a more comprehensive computerized neurocognitive test (such as ImPACT).

Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state a table of pre-defined acceptance criteria for the ImPACT Quick Test itself, in terms of specific performance thresholds (e.g., a minimum correlation coefficient). Instead, the studies aim to demonstrate construct validity, concurrent validity, and test-retest reliability as evidence of the device's performance, aiming to show substantial equivalence to the predicate device.

The reported device performance aligns with these goals:

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ImPACT is intended for use as a computer-based neurocognitive 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 12-59.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) is a computer-based neurocognitive test battery.

ImPACT is a software-based tool that allows healthcare professionals to conduct a series of neurocognitive tests on individuals to gather basic data related to the neurocognitive functioning of the test subject. This computerized cognitive test battery evaluates and provides a healthcare professional with measures of various neurocognitive functions, including the reaction time, memory, attention, spatial processing speed and symptoms of an individual.

ImPACT provides healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices and is intended to be used as part of a multidisciplinary approach to making return to activity decisions.

The ImPACT device is a computer-based neurocognitive test battery intended to aid in the assessment and management of concussion. The submission focuses on a device modification – a rewrite of the software from Adobe Flash to HTML5/CSS/JavaScript, while preserving all functions of the original version. The performance testing aims to demonstrate that this software change does not affect the device's functionality or performance.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of acceptance criteria with specific quantifiable metrics like sensitivity, specificity, or AUC, as might be seen for a diagnostic AI device. Instead, the acceptance criteria are implicitly tied to demonstrating non-inferiority or statistical and clinical insignificance of differences between the new HTML5 version and the predicate Flash version, specifically for reaction time. The primary performance metric assessed was "reaction time."

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

• Test Set Sample Size: "one in volunteers age 19-22". While a specific number is not provided, this indicates a human user study. The bench study would not involve a "sample size" in the same way, but rather controlled test conditions.
• Data Provenance: The document does not specify the country of origin of the data. It appears to be a prospective study conducted for the purpose of this submission, comparing the new and old software versions.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. Given the nature of the device (a neurocognitive test battery for concussion assessment) and the type of performance testing described (comparison of reaction time between software versions), it's unlikely that external medical experts were used to establish "ground truth" in the typical sense (e.g., image annotation for disease presence). The "ground truth" here is the actual reaction time measurement as recorded by the device.

4. Adjudication Method for the Test Set

This information is not provided and is likely not applicable. Since the study is comparing measurements (reaction time) between two software versions rather than subjective interpretation of data, an adjudication method for reconciling expert opinions would generally not be needed.

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

A MRMC comparative effectiveness study was not done. The study described focused on direct comparison of output (reaction time) between two software versions rather than evaluating the impact of AI assistance on human readers' diagnostic performance. The device itself is an assessment aid, not an AI for image reading or interpretation that augments a human reader.

6. Standalone (Algorithm Only) Performance Study

The study described is essentially a standalone performance study in the context of the device modification. It evaluates the performance of the new HTML5 algorithm directly against the predicate Flash algorithm, without involving human interpretation or human-in-the-loop assistance in the performance assessment itself. The "volunteers" in the study are the subjects on whom the reaction time is measured by the device itself.

7. Type of Ground Truth Used

The "ground truth" for this performance study was the objective measurement of reaction time. The study aimed to show that the new software version produced reaction time measurements statistically and clinically equivalent to those from the predicate software version. This is not a ground truth derived from expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device.

8. Sample Size for the Training Set

This information is not provided. As this submission relates to a software re-write of an existing device and not the development of a new AI/ML model from scratch, there might not be a separate "training set" in the conventional machine learning sense. If the underlying neurocognitive test battery involved trained algorithms, that training would have occurred for the original predicate device, and the re-write aimed to replicate its behavior.

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

This information is not provided. Similar to point 8, if there was initial algorithm training for the predicate device, the method for establishing its ground truth is not detailed in this document. Given it's a neurocognitive test battery, the initial "ground truth" would likely have been established through extensive psycho-metric validation, normative data collection, and clinical trials for the original ImPACT device to ensure its measurements accurately reflect neurocognitive function in the context of concussion.

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ImPACT is intended for use as a computer-based neurocognitive 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 12-59.

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

ImPACT Pediatric 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 5-11.

ImPACT® (Immediate Post-Concussion Assessment and Cognitive Testing) and ImPACT Pediatric are computer-based neurocognitive test batteries for use as an assessment aid in the management of concussion.

ImPACT and ImPACT Pediatric are software-based tools that allows healthcare professionals to conduct a series of neurocognitive tests that provide data related to the neurocognitive functioning of the test taker. This computerized neurocognitive test battery 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.

ImPACT and ImPACT Pediatric provide healthcare professionals with a set of well-developed and researched neurocognitive tasks that have been medically accepted as state-of-the-art best practices. The devices are intended to be used as part of a multidisciplinary approach to concussion assessment and patient management.

This response summarizes the acceptance criteria and supporting studies for the ImPACT and ImPACT Pediatric devices, as detailed in the provided document.

Acceptance Criteria and Device Performance

The acceptance criteria for ImPACT and ImPACT Pediatric are primarily demonstrated through the establishment of their psychometric properties: construct validity, test-retest reliability, and the development of a robust normative database. The device performance is reported through the results of various peer-reviewed studies and clinical data supporting these properties.

Table 1: Acceptance Criteria and Reported Device Performance

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