The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination.

A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion.

A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.

Device Description

The SyncThink EYE-SYNC device is a portable, fully enclosed eye tracking environment with three primary components:

1. Eye Tracker (head-mounted device) with eye tracking sensor
1. Eye tracking display
1. Android Tablet

The eye tracker is a modified Samsung GearVR provided by SensoMotoric Instruments (SMI). It is mounted to the subject's face and held either by hands placed on the side or using a strap. The eye tracking sensor includes two high-speed infrared cameras (for each eye) connected to a visual display for battery, computation, and display. Camera lighting is provided by 12 high-quality Light-emitting Diodes (LEDs) centered at 850 nanometers. Eye gaze tracking is performed using a proprietary implementation of the pupil- corneal reaction method. The eye tracker display is a nonnetworked mobile device that fits within the eye tracking sensor and connects over USB. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance:

Smooth Pursuit
· Saccades
· Vestibular-Ocular Reflex (VOR)
· VOR Cancellation (VORx)

An EYE-SYNC software app on the display device manages these functions.

The Android tablet is a standard off-the-shelf 9.7" mobile tablet from Samsung with Verizon 4G cellular connectivity. A second EYE-SYNC software app designed to provides an integrative platform for data collected on the HMD eye tracker:

· Patient, administrator, and records management
· Eye tracker assessment Bluetooth control
· Assessment Vestibular/Ocular-Motor Screening (VOMS) self-report tools
· Eye tracker assessment real-time Bluetooth monitoring
Eye tracker data log Bluetooth transfer
Eye tracker assessment analysis using visual synchronization metrics
· Analysis report generation with visualizations
· Background diagnostics to verify device health
· Cloud connectivity for data synchronization

Internal batteries from the eye tracking display and Android tablet provide power for remote use, away from power source. Each device has an EYE-SYNC software app installed to provide the described functionality. EYE-SYNC is provided as a complete system and both apps are managed a single software project with identical version numbers. EYE-SYNC is provided in a standalone carry-case with user manual, strap, cleaning, and charging accessories.

AI/ML Overview

The provided text describes the regulatory clearance of the EYE-SYNC device. Here's a breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Sensitivity (Detection of Concussion)	82% (95% CI: 74%, 89%)	Meets the performance demonstrated by the predicate device (80.4%).
Specificity (Non-detection of Concussion)	93% (95% CI: 91%, 94%)	Significantly higher than the predicate device (66.1%), indicating better ability to correctly identify non-concussed individuals.
Negative Predictive Value (NPV)	98% (95% CI: 97%, 99%)	Higher than the predicate device (94.5%), indicating excellent ability to rule out concussion when the test is negative.
Positive Predictive Value (PPV)	56% (95% CI: 48%, 64%)	Higher than the predicate device (31.6%), indicating improved ability to identify concussion when the test is positive, though still with a notable rate of false positives. (Note: PPV and NPV calculated based on observed study prevalence of 10% concussion).
Test-Retest Reliability (for specific metrics)	SD tangential error: ICC = 0.86 (0.82, 0.90) SD radial error: ICC = 0.78 (0.71, 0.84) Mean phase error: ICC = 0.83 (0.77, 0.87)	High ICC values indicate strong reliability of the measurements.
Electrical Safety	Complied with IEC 60601-1:2012 Ed. 3.0 and IEC 60601-2-57:2011 Ed1.0.
Electromagnetic Compatibility (EMC)	Complied with IEC 60601-1-2:2014 Ed 4.0.
Software Verification and Validation	Conducted according to FDA Guidance, considered "moderate" level of concern.
Cybersecurity	Assessed and documented according to FDA Guidance.
Light Safety (Photobiological Safety)	Conformed to EN62471.
Biocompatibility	Cytotoxicity, Sensitization, and Irritation tests conducted and passed.	(Specific results not given, but stated to be conducted in accordance with ISO 10993-1).

2. Sample Size and Data Provenance

Test Set Sample Size: 1,069 subjects
Data Provenance: The study was a retrospective analysis of subjects ages 17-24 years actively engaged in competitive athletics. The location/country of origin is not explicitly stated, but the context of FDA clearance for a US market implies the data is relevant to a US population or sufficiently representative thereof. The study involved patient evaluations conducted by healthcare practitioners blinded to EYE-SYNC device output "+3 days from injury," suggesting it was collected progressively for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated as a specific number of individual experts.
Qualifications of Experts: The ground truth for concussion was established using the SCAT-5 clinical reference standard definition of concussion, with evaluations conducted by "a healthcare practitioner blinded to EYE-SYNC device output." While specific qualifications like "radiologist with 10 years of experience" are not provided, "healthcare practitioner" implies a medical professional (e.g., physician, athletic trainer, nurse practitioner) trained in concussion assessment.

4. Adjudication Method for the Test Set

The text states that the SCAT-5 clinical reference standard definition of concussion was used, with evaluations conducted by a single healthcare practitioner who was blinded to the EYE-SYNC device output. There is no mention of multiple readers or an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to have been based on this single blinded practitioner's assessment using the SCAT-5.

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

No MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone algorithm's performance in aid of diagnosis. The device's use is explicitly "in conjunction with a standard neurological assessment," implying it's an aid to a human clinician, but the study itself does not measure the human-in-the-loop performance change.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was clearly done. The reported sensitivity, specificity, PPV, and NPV are for the EYE-SYNC device's classification algorithm. The healthcare practitioner who established the ground truth was "blinded to EYE-SYNC device output," which supports this being a standalone performance assessment of the algorithm against clinical ground truth.

7. Type of Ground Truth Used

The ground truth used was expert consensus / clinical reference standard: The SCAT-5 clinical reference standard definition of concussion, as determined by a blinded healthcare practitioner. This is a widely accepted clinical tool for concussion assessment.

8. Sample Size for the Training Set

The text does not explicitly state the sample size for the training set. The provided data focuses solely on the "validation data analysis" performed on 1,069 subjects, which represents the test set.

9. How Ground Truth for Training Set Was Established

Since the training set size is not provided, the method for establishing its ground truth is also not explicitly described in this document. It is typically assumed that training data ground truth would be established through similar expert labeling or clinical diagnosis processes, but no details are given here.

Summary

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 2, 2021

SyncThink, Inc. % Allison Kumar Regulatory Consultant Arina Consulting, LLC 27 Hilltop Dr San Carlos, California 94070

Re: K202927

Trade/Device Name: EYE-SYNC Regulation Number: 21 CFR 882.1455 Regulation Name: Traumatic brain injury eye movement assessment aid Regulatory Class: Class II Product Code: QEA Dated: August 18, 2020 Received: September 29, 2020

Dear Allison Kumar:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 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) K202927

Device Name EYE-SYNC

Indications for Use (Describe)

The EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.

A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion.

A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with 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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510(k) Summary

This summary is being submitted in accordance with the requirements of 21 CFR Part 807.92.

510(k) Owner Information:

SyncThink, Inc. 2172 Staunton Court Palo Alto, CA 94306 Tel 508-446-4287 Contact: John Ferreira, VP Engineering jferreira@syncthink.com

Submission Correspondent:

Allison Kumar Arina Consulting, LLC allison@arinaconsulting.com

Device Information:

Trade Name: EYE-SYNC Device: Traumatic Brain Injury Eye Movement Assessment Aid Regulation: 882.1455 Classification Panel: Neurology Device Class: 2 Product Code: QEA

Predicate Device:

Oculogica EveBOX (DEN170091)

Reference Devices:

SyncThink EYE-SYNC (K152915), GN Otometric 1068 A/S Type 1085 ICS Impulse (K151504)

Intended Use/Indications for Use:

The EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.

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patients 17 -24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination.

A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion.

A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.

Device Description:

The SyncThink EYE-SYNC device is a portable, fully enclosed eye tracking environment with three primary components:

1. Eye Tracker (head-mounted device) with eye tracking sensor
1. Eye tracking display
1. Android Tablet

Smooth Pursuit
· Saccades
· Vestibular-Ocular Reflex (VOR)
· VOR Cancellation (VORx)

An EYE-SYNC software app on the display device manages these functions.

· Patient, administrator, and records management
· Eye tracker assessment Bluetooth control
· Assessment Vestibular/Ocular-Motor Screening (VOMS) self-report tools
· Eye tracker assessment real-time Bluetooth monitoring

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Eye tracker data log Bluetooth transfer
Eye tracker assessment analysis using visual synchronization metrics
· Analysis report generation with visualizations
· Background diagnostics to verify device health
· Cloud connectivity for data synchronization

Comparison of Technological Characteristics with Predicate Device:

The claim of substantial equivalence of EYE-SYNC to the predicate device is based on a detailed comparison of several factors. This compairson is included in the table below:

	Subject Device(EYE-SYNC)	Predicate Device(Eye-BOX)
SubmissionNumber	K202927	DEN170091	Comparison
Product Code	QEA	QEA	SAME
Intended Use	Measure andanalyze eyemovement as an aidin the diagnosis ofconcussion	Measure andanalyze eyemovement as an aidin the diagnosis ofconcussion	SAME
Indications forUse	The EYE-SYNC® isintended forrecording, viewing,and analyzing eyemovements insupport of identifyingvisual trackingimpairment in humansubjects.The EYE-SYNC® isintended to record,measure, andanalyze eyemovements as an	The EyeBOX isintended to measureand analyze eyemovements as anaid in the diagnosisof concussion withinone week of headinjury in patients 5through 67 years ofage in conjunctionwith a standardneurologicalassessment of	SIMILARDifferences between thesubject device and predicateinclude:• Age range of population forsubject device is a smallsubset of predicate.• Population of subject deviceis specific to sports-relatedinjury.• Use of test is a shorter timeperiod since injury comparedto predicate.The differences do not raise
	aid in the diagnosisof concussion withinthree days of sport-related head injuryin patients 17 -24years of age inconjunction with astandardneurologicalassessment, for useby medicalprofessionalsqualified to interpretthe results of aconcussionassessmentexamination and aidin the managementof concussion.A negative EYE-SYNC®classificationcorresponds to eyemovements thatare consistent witha lack ofconcussion.A positive EYE-SYNC®classificationcorresponds to eyemovements thatmay be present inpatients withconcussion.	concussion.A negative EyeBOXclassification maycorrespond to eyemovement that isconsistent with alack of concussion.A positive EyeBOXclassificationcorresponds to eyemovement that maybe present in bothpatients with orwithout concussion.	new questions of safety oreffectiveness.
Rx Use Only	Yes	Yes	SAME
HardwareComponents	VR HeadsetTablet	Stand withintegrated Computer	DIFFERENTSubject device uses VRheadset to capture gazemeasurements. Analysis isdone via a software app on theaccompanying tablet. Thismethod has been validatedwith performance and clinicaltesting to verify it provides thesame information as the

			predicate device and thereforedoes not raise new questionsof safety and effectiveness.
WirelessCommunication	Bluetoothconnection betweenVR Headset andTablet. Tablet has4G cellularconnection Cloud.	Single, non-networked device	DIFFERENTSubject eye tracking devicecommunicates over Bluetoothwireless to an administrativetablet for control and dataexchange. The predicatedevice achieves the samefunctionality within a singlecomputer system.Cellular connectivity to thecloud is a convenience featureand does not contribute to theIFU. Bluetooth connectivity is acommon systems interface.This method has beenvalidated with performanceand clinical testing to verify itprovides the same functionalityas the predicate device andtherefore does not raise newquestions of safety andeffectiveness.

Eye Tracking	Gaze	Gaze	SAME
Camera Speed	60 Hz	500 Hz	DIFFERENTEye tracking cameras can beoversampled with respect tothe signal of interest. Thesubject device has elected togo with a lower sample rate,but has validated this decisionwith performance and clinicaltesting to verify it provides thesame functionality as thepredicate device and thereforedoes not raise new questionsof safety and effectiveness.
			therefore does not raise newquestions of safety andeffectiveness.
Software	Algorithm providesanalysis and results	Algorithm providesanalysis and results	SAME
PatientContactingMaterials	Yes - Foam cushionon face mask.	N/A	DifferentPatient contacting material isbiocompatible. Does not raisenew questions of safety oreffectiveness.
Sterility	Non-Sterile	Non-Sterile	SAME
EMC andElectricalSafety	IEC 60601-1:2012IEC 60601-1-2:2014	IEC 60601-1:2012IEC 60601-1-2:2014	SAME
PerformanceTesting - Bench	Light Safety	Light Safety	SAME
PerformanceTesting -Clinical	82% sensitivity(74%, 89%)93% specificity(91%, 94%)56% PPV*(48%, 64%)98% NPV*(97%, 99%)	80.4% sensitivity(66.1%, 91.9%)66.1% specificity(59.7%, 72.1%)31.6% % PPV(23.3%, 40.9%)94.5% NPV(89.9%, 97.5%)	SimilarResults from clinical testingare substantially equivalent topredicate device*
SpecialControls	Yes	Yes	SAME

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*Clinical performance analysis did not include assessments with poor eye-tracking quality. In these cases, the device does not provide an assessment result.

**95% Confidence intervals noted for the subject and predicate device are derived from Clopper-Pearson method. 95% Confidence intervals for the subject device derived using the Wilson Score method for sensitivity are (74%, 88%) and (91%, 94%) for specificity.

*** PPV and NPV was obtained from observed study data without adjustment of the prevalence (10%).

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

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Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the EYE-SYNC device. The system complied with the IEC 60601-1:2012 Ed. 3.0 standard for operator and patient safety and IEC 60601-1-2:2014 Ed 4.0 standard for EMC in the intended use environment. The system complied with IEC 60601-2-57:2011 Ed1.0 Medical electrical equipment – Part 2 for safety of non-laser light source equipment intended for diagnostic use.

Software Verification and Validation Testing and Cybersecurity

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator, either directly or indirectly through incorrect or delayed information or through the action of a care provider.

Cybersecurity was assessed and documented according to the FDA Guidance, "Off-the-shelf Software - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software."

Performance Testing - Bench

Testing was performed to demonstrate conformance with the following standards:

EN62471 Photobiological Safety of Lamps and Lamp Systems

Biocompatibility Testing

The biocompatibility evaluation of the EYE-SYNC device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, "" May 1, 1005, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity .
Sensitization ●
Irritation

Sterility

The device is provided non-sterile. Cleaning instructions are provided in

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the user manual.

Summary of Clinical Testing:

Clinical performance

Clinical data was submitted to support substantial equivalence and conform to special controls. Validation data analysis was performed on 1,069 subjects. The validation study population included subjects ages 17-24 years actively engaged in competitive athletics. Of these 1,069 subjects, 107 subjects met the SCAT-5 clinical reference standard definition of concussion, where the evaluations were conducted by a healthcare practitioner blinded to EYE-SYNC device output +3 days from injury.

Retrospective analysis determined 82% (74%, 89%) sensitivity and 93% (91%, 94%) specificity of the EYE-SYNC test. Negative predictive value made by the classifying algorithm was 98% (97%, 99%) and positive predicative value was 56% (48%, 64%). For PPV and NPV reference, the study prevalence of clinical classification of concussion (mTBI) was 10% (107/1069). The analysis validates the clinical utility of the eye-tracking assessment as an aid in diagnosis of concussion within three days of sport-related head injury.

Test-retest reliability

The test-retest reliability of the EYE-SYNC metrics were reported through an independent study of 150 athletes from 11 sports with a mean (SD) age of 20 (1.3) years and 55% female population. The Intra-class correlation (ICC) was calculated with its 95%CI for each EYE-SYNC metric:

SD tangential error: 0.86 (0.82, 0.90) .
SD radial error: 0.78 (0.71, 0.84) .
Mean phase error: 0.83 (0.77, 0.87) .

The ICC describes the level of correlation between two or more observations made on the same student athlete; a higher ICC (closer to 1) indicates greater reliability of the measure.

Conclusion:

The non-clinical and clinical data support the safety of the device and the software verification and validation demonstrate that SyncThink's EYE-SYNC device should perform as intended in the specified use conditions, and which are comparable to the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 882.1455 Traumatic brain injury eye movement assessment aid.

(a)
Identification. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the patient's brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following:
(i) Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis;
(ii) Evaluation of device test-retest reliability; and
(iii) A description of the development of the reference method of diagnosis, which may include a normative database, to include the following:
(A) A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and
(B) If using a normative database, a description of how the “normal” population was established, and the statistical methods and model assumptions used.
(2) Software verification, validation, and hazard analysis must be performed. Software documentation must include a description of the algorithms used to generate device output.
(3) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) A light hazard assessment must be performed for all eye-tracking and visual display light sources.
(6) Labeling must include:
(i) A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability;
(ii) A description of any normative database that includes the following:
(A) The clinical definition used to establish a “normal” population and the specific selection criteria;
(B) The format for reporting normal values;
(C) Examples of screen displays and reports generated to provide the user results and normative data;
(D) Statistical methods and model assumptions; and
(E) Any adjustments for age and gender.
(iii) A warning that the device should only be used by trained healthcare professionals;
(iv) A warning that the device does not identify the presence or absence of traumatic brain injury or other clinical diagnoses;
(v) A warning that the device is not a standalone diagnostic; and
(vi) Any instructions to convey to patients regarding the administration of the test and collection of test data.