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.

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 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:

Acceptance Criteria (Implied)	Reported Device Performance
1. Normative Database for iPad: The device must establish a reliable and representative normative database for performance on an iPad, allowing for accurate interpretation of test results compared to a healthy population.	A prospective clinical investigation was conducted to collect data for standardization and to construct the normative database for tests performed on an iPad. The normative sample included 1495 subjects ages 12-59 (670 males, 825 females). Data was collected prospectively from 4 different sites across the US in 2022 and 2023. These sites were approved by two ethics boards (Advarra IRB Services and St. Joseph's University in Philadelphia). Data collection occurred in a mixed environment (supervised and unsupervised testing) to approximate real-world conditions. All subjects met inclusion criteria consistent with previous normative data creation (age 12-59, primary English speaking, no concussion in past 6 months, no known physical/neurological/behavioral/psychological impairment affecting test, corrected hearing/vision impairments, signed IRB consent).
2. Test-retest Reliability (iPad): The neurocognitive measures on the iPad must demonstrate high consistency over time, meaning a subject's scores should be similar if they take the test multiple times within a reasonable period, assuming no change in their cognitive state.	Test-retest reliability was calculated in a sample of 116 individuals ages 12-59 who were part of the standardization sample. They completed an initial baseline assessment on an iPad and a second baseline within 7-21 days (mean=12.7 days, SD=4.3 days). Pearson's Product-Moment Correlation coefficients and Intra-class correlation coefficients (ICCs) were calculated for ImPACT Composite Scores and Two Factor Scores. The reported Pearson's correlations and ICCs were "consistent with those from the test-retest coefficients obtained using Mouse and Trackpad inputs of the predicate device." This indicates that the iPad version maintains the reliability characteristics of the established predicate device.
3. Safety and Effectiveness (Overall Equivalence): The device modifications (specifically the iPad platform and related software for touchscreen input and normative data) must not adversely affect the safety or effectiveness for its intended use, nor raise new questions of safety and effectiveness.	The document states: "The differences between the two devices described above do not affect the safety or effectiveness of ImPACT Version 4.1 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 assessments." Risk management activities were conducted per ISO 14971, assuring risks are controlled and the new device has the same safety and risk profile as the predicate. Software verification and validation (IEC 62304, FDA Guidance "General Principles of Software Validation") included code reviews, design reviews, automation/manual testing, and regression testing, with all tests meeting acceptance criteria.

Detailed Study Information:

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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September 16, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

Re: K231688

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 17, 2023 Received: August 17, 2023

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

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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.

Jay R. Gupta -S

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

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Indications for Use

510(k) Number (if known) K231688

Device Name ImPACT Version 4

Indications for Use (Describe)

ImPACT is intended for use as a computer-based neurocogntive 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)

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Image /page/3/Picture/0 description: The image is a logo for ImPACT Applications, Inc. The logo features a stylized image of a human head in profile, with a brain depicted inside the head. To the right of the head is the text "ImPACT" in a sans-serif font, with the "Im" in a dark blue color and the "PACT" in a lighter blue color. Below the word "ImPACT" is the text "APPLICATIONS, INC." in a smaller, sans-serif font.

Prepared Date: June 08, 2023

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, K202485
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:

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Image /page/4/Picture/1 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, with "Applications, Inc." written in smaller letters below. The logo is simple and professional, and it is likely used to represent a company that specializes in brain-related products or services.

Device Modifications:

The New Device, ImPACT Version 4, is substantially equivalent to the Predicate Device (ImPACT Version 4) cleared under K202485. Both devices have the same 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.

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. normative database for iPad for ages 12-59;
1. minor software modifications to support use of touchscreen devices, to improve maintainability, cybersecurity and enhance user experience.

Table 1. Predicate Comparison.
Characteristic	Predicate Device: ImPACT Version 4(K202485)	Reference Device: ImPACTQuick Test (K170551)	New Device: ImPACTVersion 4 (rev 4.1)
Intended Use	ImPACT Version 4 is intended for use as acomputer-based neurocognitive test battery toaid in the assessment and management ofconcussion.ImPACT Version 4 is a neurocognitive testbattery that provides healthcare professionalswith objective measure of neurocognitivefunctioning as an assessment aid and in themanagement of concussion in individuals ages12-80.	ImPACT Quick Test isintended for use as acomputerized cognitive testto aid in the assessment andmanagement of concussion inindividuals ages 12-70.	Same as Predicate Device
Patient Population	12-80	12-70	Same as Predicate Device
Use Environment	Unsupervised and supervised environment forbaseline testing.Supervised environment only for post-injurytesting.	Supervised environment onlyfor post-injury testing.	Same as Predicate Device
Neurocognitive testbattery	1. Demographic data, (age, gender,concussion history, relevant medicalinformation)2. Symptoms list and questionnaires3. Neurocognitive test battery consisting of 6modules:Module 1: Word Memory and DelayedMemory Recognition Module 2: Design Memory and DelayedDesign Recognition Module 3: X's and O's Module 4: Symbol Matching Module 5: Color Match Module 6: Three Letter Memory	1. Basic Demographic data,(age, gender)2. Observed Signs andReported Symptoms list3. Neurocognitive testconsisting of 3 modules:Module 1: SymbolMatch Module 2: ThreeLetters Module 3: EyeTracker	Same as Predicate Device
Results	1. Recording and scoring of symptoms2. Raw Scores, Composite Scores, andvalidity supporting indexes.3. Normative data	1. Recording and scoring ofsymptoms2. Composite Scores3. Normative data	Equivalent.Added normative databasefor tests taken on an iPad

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	ImPACT Version 4.1 - Traditional 510(k) Summary
Suggest options ortreatment	No	No	Same as predicate
Platform	Stand-alone software running on generalpurpose commercial off-the-shelf personalcomputers (desktops, laptops), with a modernweb browser connected to the internet.	Apple iPad	Equivalent.The new device adds optionto administer the test on aniPad.
Software Technology	Software application, written in HTML5,accessed via standard web browser	Software application nativeto iPadOS	Equivalent.On an iPad, the test can beaccessed through a webbrowser (like the predicate)or native iPadOS application
Stimulus presentation	Information and stimulus displayed on adesktop or laptop computer screen	Information and stimulusdisplayed on an iPad	New device adds option touse iPad (stimulus displayedon iPad screen)
Stimulus capture (testtaker response)	Device uses computer peripherals to capture tetaker's response	Device uses iPad touchscreento capture test taker'sresponse	Equivalent.New device capturesresponses via touchscreen
Data Storage	Remote central database	Remote central database	Same as predicate
Standards Used	ISO 14971 and IEC 62304	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 the same safety characteristics as the Predicate Device and same risk profile.

Clinical Data:

The 510(k) included the results of clinical studies. The results of these studies demonstrate the New Device provides a reliable measure of cognitive function to aid in assessment and management of concussion and is therefore substantially equivalent to the Predicate Device.

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To support the test administration on iPad and to provide a normative database, a prospective clinical investigation was conducted to collect data to: (i) standardize the test and construct the normative database for tests performed on iPad; and (ii) demonstrate test-retest reliability.

i. Standardization and Normative sample

The normative sample 1495 subjects ages 12-59 (670 males, 825 females) was collected prospectively from 4 different sites with study participants across the US. Data collection took place in 2022 and 2023. The sites were approved to collected data by two ethics boards, Advarra IRB Services (for supervised testing) and St. Joseph's University in Philadelphia (for unsupervised remote testing). All subjects met theappropriate inclusion criteria, which are the same as those used for creating normative tables for the mouse and trackpad in the predicate device. Data for the new sample was conducted in mixed environment including supervised and unsupervised testing to best approximate the real-world performance.

All subjects had to meet the following inclusion criteria to be eligible: (i) test administered on iPad; (ii) age: 12-59; (iii) primary English speaking or fluent in English; (iv) not suffering from a concussion or being treated for a concussion in the past 6 months; (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 outside of normal limits (e.g. prescription glasses, hearing aid), and (vii) a signed IRB approved consent form.

ii. Test-retest Reliability

Over the years, there have been a sizeable body of literature that has documented the reliability of ImPACT. In general, ImPACT has been found to be highly reliable across time. As the items of the test and the six modules have not changed, this literature is relevant to this version of ImPACT as well as all previous version (predicates). Summary of these studies is provided in the device labeling.

The test-retest reliability was also calculated in a sample of participants using the iPad version of the test. Test takers were 116 individuals ages 12-59 from the standardization sample who completed an initial baseline assessment using an iPad, and a second baseline with a between test interval ranging of 7 to 21 days (mean=12.7 days) SD=4.3 days). Test-takers were 40 males (34.5%, mean age 26.6, SD=14.2 years) and 76 females (65.5%, mean age 28.9, SD=14.4 years), with no significant age difference between based on gender (p=.40). Test-retest reliability was calculated Pearson's Product-Moment Correlation coefficients as well as intra-class correlation coefficients (ICCs) for the ImPACT Composite Scores as well as Two Factor Scores. Pearson's correlations and ICCs are consistent with those from the test-retest coefficients obtained using Mouse and Trackpad inputs of the predicate device.

Substantial Equivalence Conclusion:

The differences between the two devices described above do not affect the safety or effectiveness of ImPACT Version 4.1 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 assessments. Therefore, ImPACT Version 4.1 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.