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.

Device Description

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).

AI/ML Overview

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.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Software functionality met design specifications.	All software verification activities (code reviews, design reviews, walkthroughs, software V&V testing, regression testing) met "required acceptance criteria." Modifications did not affect existing functionality.
Device modifications do not affect safety or effectiveness.	"The differences between the two devices... do not affect the safety or effectiveness of ImPACT Version 4 for its intended use and do not raise new questions of safety and effectiveness, which was demonstrated through risk management and performance testing." Risk management concluded all individual risk is acceptable and the new device has "virtually the same safety characteristics... and same risk profile" as the predicate.
Test-retest reliability is established (for ages 60-80).	For a subset of 93 individuals (ages 60-80), only a "small percentage" (0-1% for composite scores, 0-2% for factor scores) of scores showed "reliable or 'significant' change" over an average of 16.04 days. This "suggest[s] the cognitive performance of test takers at baseline remained stable over a one-month period."
Construct validity correlated with established tests (for ages 60-80).	ImPACT Verbal Memory Composite scores correlated significantly (P<.001) with HVLT and BVMT-R, and SDMT Memory Sub-scales. ImPACT Motor Speed and Reaction Time Composite Scores both correlated with the SDMT Total Correct Subscales.
Normative database is established and robust for extended age range (60-80).	A normative database was constructed for ages 60-80 from 554 subjects across 8 sites in the US, meeting specific inclusion/exclusion criteria.
Normative database is updated and robust for existing age range (12-59).	A normative database for ages 12-59 was constructed from 71,815 de-identified subjects selected from a larger company database (766,093 records), with separate calculations for mouse and trackpad. Subjects met specific criteria (age, gender, English speaker, input device, no recent concussion, no neurological issues, no ADHD/LD).
Device provides reliable measure of cognitive function to aid in assessment.	"The results of these studies demonstrate ImPACT Version 4 provides a reliable measure of cognitive function to aid in assessment and management of concussion and is therefore substantially equivalent to the Predicate Device." (This is a summary statement based on the overall findings, not a specific performance metric.)

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

The document describes several "clinical studies" or investigations which serve as test sets for different aspects (normative data, reliability, validity).

For the 12-59 age range (normative database update):
- Sample Size: 71,815 subjects.
- Data Provenance: Retrospective, de-identified data from the Company's test database of 766,093 subjects. Subjects were from the United States of America.
For the 60-80 age range (normative database, test-retest reliability, construct validity):
- Normative Sample Size: 554 subjects (174 males, 380 females).
- Test-retest Reliability Sample Size: 93 individuals (a subset of the normative extension sample, 64.5% females, 35.5% males).
- Construct Validity Sample Size: 71 individuals (ages 60-80, 63.4% females, 36.6% males).
- Data Provenance: Prospective clinical investigation. Data collected from 8 different sites across the United States (universities, hospitals, clinics, private medical practices). Data collection began in 2017 and ended in 2020.

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

The document does not explicitly state the number of experts used to establish a "ground truth" for the test set in the sense of adjudicating concussion status for individual subjects within the studies.
For the construct validity study, the document states: "All measures were administered by Neuropsychologists trained in test administration as part of the study to collect data for normative dataset described above." These Neuropsychologists administered the comparative tests (HVLT, BVMT-R, SDMT) which served as the "ground truth" or reference standard for comparison, but they were not adjudicating the ImPACT scores or concussion status. They were experts in administering and interpreting the comparative neuropsychological tests.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the typical sense (e.g., 2+1 rater adjudication) for determining ground truth of concussion or for evaluating the ImPACT scores.
Instead, the studies used established clinical methods:
- For the normative database, subjects were selected based on self-reported criteria (no recent concussion, no neurological issues, no ADHD/LD diagnosis) and, for the 60-80 age range, MMSE scores (>24).
- 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.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

December 25, 2020

ImPACT Applications, Inc. Michael Zagorski Director of Regulatory Affairs 2140 Norcor Ave.. Suite 115 Coralville, Iowa 52241

Re: K202485

Trade/Device Name: ImPACT Version 4 Regulation Number: 21 CFR 882.1471 Regulation Name: Computerized Cognitive Assessment Aid For Concussion Regulatory Class: Class II Product Code: POM Dated: August 28, 2020 Received: August 31, 2020

Dear Michael Zagorski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202485

Device Name ImPACT Version 4

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized drawing of a human head with a brain inside, next to the company name in blue letters. The word "ImPACT" is in a larger font than "Applications, Inc.", and the "Im" is a darker blue than the "PACT". The logo is enclosed in a black border.

Submission Date: August 28, 2020

Submitter Information:

Company:	ImPACT Applications, Inc.2140 Norcor Ave., Suite 115Coralville, IA 52241
Contract Person:	Michael ZagorskiDirector of Regulatory AffairsImPACT Applications, Inc.Tel: 412-567-8400 ext. 939Email: mzagorski@impacttest.com
Device Information:
Trade Name:	ImPACT® Version 4
Classification Name:	Computerized cognitive assessment aid for concussion
Device Classification:	Class II
Product Code:	POM, 21 CFR 882.1471
Panel:	Neurology
Predicate Device:	ImPACT, K181223
Reason for submission:	Device Modifications

Indications for Use:

lmPACT Version 4 is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Version 4 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.

Device Description:

{4}------------------------------------------------

Device Modifications:

The new device, ImPACT Version 4, is substantially equivalent to the predicate device (ImPACT Version 3.3.0) cleared under K181223. Both devices have intended use as a computerized neurocognitive test to aid in the assessment and management of concussion. They are also identical in terms of technological characteristics as both are stand-alone software applications using a general-purpose computing platform to electronically record objective performance measurements (speed and accuracy) as the test taker responds to stimuli presented on the screen via input devices. Further, there are no changes to the functionality or to the design of the neurocognitive test battery; all tasks, stimuli, and captured information remain identical to the predicate device.

There are no changes to the intended use, use environment characteristics, or the conditions assessed.

The differences between the new device and the predicate include:

1. applicable age range for the test has been extended to 80 years (the new age range is 12-80);
normative database has been updated on a new sample and separate normative calculations were 2. provided for mouse and trackpad;
changes to device output: 3.
- O addition of a new output score called Two-Factor Score to assist with the interpretation of results;
- modification to the Invalidity Indicator calculations based on the new normative data set; and o
- removal of the CEI (cognitive efficiency index); O
1. minor software modifications to improve maintainability, cybersecurity and enhance user experience.

Table 1. Predicate Comparison.
Characteristic	Predicate Device: ImPACT (K181223)	Modified Device: ImPACTVersion 4
Intended Use	ImPACT is intended for use as a computer-based neurocognitive testbattery to aid in the assessment and management of concussion.ImPACT is a neurocognitive test battery that provides healthcareprofessionals with objective measure of neurocognitive functioning asan assessment aid and in the management of concussion in individualsages 12-59.	Same intended useModified indications - age range ofthe patient population wasextended to 80.
Patient Population	12-59	Different from predicate.New age range is 12-80
Use Environment	Unsupervised and supervised environment for baseline testing.Supervised environment only for post-injury testing.	Same as predicate
Neurocognitive testbattery	1. Demographic data, (age, gender, concussion history, relevantmedical information)2. Symptoms list and questionnaires3. Neurocognitive test battery consisting of 6 modules:Module 1: Word Memory and Delayed Memory Recognition Module 2: Design Memory and Delayed Design Recognition Module 3: X's and O's Module 4: Symbol Matching Module 5: Color Match Module 6: Three Letter Memory	Same as predicate
Results	1. Recording and scoring of symptoms2. Raw Scores, Composite Scores, and validity supporting indexes.3. Normative data	Similar to predicate.

{5}------------------------------------------------

Image: IMPACT APPLICATIONS, INC. logoImPACT Version 4 - Traditional 510(k)
		New data used to construct thenormative database with separatedata sets for mouse and trackpadA new Two-Factor Score.
Suggest options ortreatment	No	Same as predicate
User Interface	Desktop or laptop computer screen to present stimuli.	Same as predicate
Platform	Stand-alone software running on general purpose commercial off-the-shelf personal computers (desktops, laptops), with a modern webbrowser connected to the internet.	Same as predicate
Software Technology	Software application, written in HTML5, accessed via standard webbrowser	Same as predicate
Stimuluspresentation	Information and stimulus displayed on a desktop or laptop computerscreen	Same as predicate
Stimulus capture(test taker response)	ImPACT uses computer peripherals to capture test taker's response	Same as predicate
Data Storage	Remote central database	Same as predicate
Standards Used	ISO 14971 and IEC 62304	Same as predicate

Summary of Performance Testing:

Software Verification and Validation.

lmPACT Version 4 software was developed, validated, and documented in accordance with IEC 62304 and FDA Guidance "General Principles of Software Validation." Software verification activities including code reviews, design reviews, evaluations, analyses, traceability assessment, and manual testing were performed in accordance with standards and guidance documents to demonstrate device performance and functionality. All tests met the required acceptance criteria:

Code reviews: peer review of all modified code performed by software developers. ●
. Walkthroughs and design reviews of mock-ups and prototypes by a cross-functional team including Developers, Quality Assurance, Regulatory Affairs function, Clinical experts, Company Management, and other stakeholders.
. Software Verification and Validation testing including automated and manual testing.
. Regression Testing: Comprehensive end testing of the test battery to verify that the modifications did not affect the existing functionality.

Risk Management:

Risk Management activities were conducted in accordance on ISO 14971 assure that all risk related to use of computerized neurocognitive test, including use related risks and cybersecurity risks, are appropriately controlled. All control measures were verified and found to be effective. All individual risk is acceptable. The new device has virtually the same safety characteristics as the Predicate Device and same risk profile.

Clinical Data:

The 510(k) included the results of clinical studies that examined the validity of ImPACT Version 4 by documenting correlations with traditional neuropsychological tests. Clinical data was also collected to examine test-retest reliability and to construct a normative database.

The results of these studies demonstrate ImPACT Version 4 provides a reliable measure of cognitive function to

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for ImPACT Applications, Inc. The logo features a stylized head with a brain inside, followed by the text "ImPACT" in a combination of dark blue and light blue. Below the word "ImPACT" is the text "APPLICATIONS, INC." in a smaller font size.

aid in assessment and management of concussion and is therefore substantially equivalent to the Predicate Device.

For the construction of the normative database for the 12-59 age range, de-identified data of 71,815 subjects were selected from Company test database of 766,093. Subjects were selected based on age, gender, type of input device they used to complete the test (i.e., computer mouse versus trackpad), spoke English as a primary language, completed a baseline test in English, and were from the United States of America. Further, in order to ensure subjects were not experiencing post-concussion symptoms or chronic effects of neurological disorders, all subjects reported as not having sustained a concussion in the 6 months prior to testing and had no other neurological issues that would affect performance (e.g., history of epilepsy, meningitis, brain surgery or other neurological disease). In addition, all subjects had no reported diagnosis of Attention Deficit Hyperactivity Disorder or Learning Disorder.

For the new age population, ages 60-80, a clinical investigation was conducted to collect data to: (i) standardize the test and construct the normative database for the new age range; (ii) demonstrate test-reliability; and (iii) establish Construct Validity.

. Standardization and Normative sample
The normative sample age 60-80 (554, 174 males, 380 females) was collected from 8 different sites across the United States, including universities, hospitals and clinics, and private medical practices. Data collection began in 2017 and ended in 2020. All sites were IRB approved with oversight from Advarra IRB services. All subjects had to meet the following inclusion criteria to be eligible: (i) age: 60-80; (ii) primary English speaking or fluent in English; (iii) not a resident in a skilled nursing facility; (iv) not suffering from a concussion or being treated for a concussion; (v) no known physical, neurological, behavioral or psychological impairment that would affect their ability to perform the test; (vi) hearing or vision impairments that have been corrected within normal limits; (vii) a score of 24 or greater on the Mini-Metal State Examination (MMSE); and (viii) a signed IRB approved consent form.
. Test-retest Reliability
A subset of participants from the normative extension sample described above, ages 60-80 (mean age of 68.18, SD=5.1 years), completed two ImPACT assessments across an average range of 30 days (mean=16.04 days, S.D. = 8.65 days). The sample consisted of a total of 93 individuals (64.5% females, 35.5% males). Using Reliable Change Indices (RCIs), only a small percentage of participants' scores showed reliable or "significant" change on the composite scores (0%-1%), or factor scores (0%-2%). These results suggest the cognitive performance of test takers at baseline remained stable over a one-month period.
. Construct Validity
To determine whether ImPACT Version 4 correlates significantly with a widely utilized and previously validated instrument of Memory and Motor Speed, select subtests of the HVLT, BVMT-R, SDMT, and ImPACT were administered within the same session. The sample was composed of 71 individuals between the ages of 60 and 80 (mean age of 67.27 years, S.D. 4.92 years) and 63.4% females and 36.6% males. All measures were administered by Neuropsychologists trained in test administration as part of the study to collect data for normative dataset described above. ImPACT Verbal Memory Composite scores correlate with both the HVLT and BVMT-R, as well as the SDMT Memory Sub-scales (significant at P<.001) which represent measures of verbal and visual memory. ImPACT Motor Speed and Reaction Time Composite Scores both correlate with the SDMT Total Correct Subscales, which represents a measure of psychomotor coding speed.

{7}------------------------------------------------

Image /page/7/Picture/2 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized image of a human head with a brain inside, followed by the text "ImPACT" in blue and light blue. Below the word "ImPACT" is the text "APPLICATIONS, INC." in smaller, black font. The logo is enclosed in a black border.

Substantial Equivalence Conclusion:

The differences between the two devices described above do not affect the safety or effectiveness of ImPACT Version 4 for its intended use and do not raise new questions of safety and effectiveness, which was demonstrated through risk management and performance testing including software verification and validation, clinical investigations and non-clinical analytical assessments. Therefore, ImPACT Version 4 is substantially equivalent to the Predicate Device.

Regulation Number and Section

§ 882.1471 Computerized cognitive assessment aid for concussion.

(a)
Identification. The computerized cognitive assessment aid for concussion is a prescription device that 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 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. It is not intended as a stand-alone diagnostic device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed.
(2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must:
(i) Evaluate device output and clinical interpretation.
(ii) Evaluate device test-retest reliability of the device output.
(iii) Evaluate construct validity of the device cognitive assessments.
(iv) Describe the construction of the normative database, which includes the following:
(A) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.
(B) Statistical methods and model assumptions used.
(3) The labeling must include:
(i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following:
(A) Device output and clinical interpretation.
(B) Device test-retest reliability of the device output.
(C) Construct validity of the device cognitive assessments.
(D) A description of the normative database, which includes the following:
(
1 ) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.(
2 ) How normal values will be reported to the user.(
3 ) Representative screen shots and reports that will be generated to provide the user results and normative data.(
4 ) Statistical methods and model assumptions used.(
5 ) Whether or not the normative database was adjusted due to differences in age and gender.(ii) A warning that the device should only be used by health care professionals who are trained in concussion management.
(iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses.
(iv) A warning that the device is not a stand-alone diagnostic.
(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.