BrainScope One is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. The BrainScope One should not be used as a substitute for a CT scan.

The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.

A negative BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.

A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.

An equivocal BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

The BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG).

BrainScope One also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.

BrainScope One also stores and displays electronic of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

Device Description

BrainScope One is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of traumatic brain injury (TBI). It also contains configurable, selectable cognitive performance tests and digitized standard assessment forms intended to provide a panel of measures to support the clinical assessment of head injury. BrainScope One provides healthcare professionals with a set of well-developed and researched concussion assessment tools.

AI/ML Overview

The provided text is a 510(k) summary for the BrainScope One device. It indicates that "No clinical or non-clinical performance data was submitted to support the device modification being made. All clinical performance data from the Ahead 300 (predicate) submission still apply."

Therefore, based on the provided text, I cannot provide details about the acceptance criteria and study proving its adherence for BrainScope One, as the document explicitly states that this information was not submitted for the BrainScope One, but rather refers to the predicate device (Ahead 300).

To answer your request thoroughly, I would need access to the 510(k) submission for the Ahead 300 (K161068), which is the predicate device the BrainScope One references for its clinical performance data.

Summary

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Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

BrainScope Company Inc. Michael Singer CEO 4350 East West Hwy. Ste 1050 Bethesda, Maryland 20814

May 18, 2018

Re: K181179

Trade/Device Name: BrainScope One Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, PKQ, OLU Dated: May 2, 2018 Received: May 2, 2018

Dear Michael Singer:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181179

Device Name BrainScope One

Indications for Use (Describe)

· BrainScope One is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. The BrainScope One should not be used as a substitute for a CT scan.

· The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.

· A negative BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.

· A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.

· An equivocal BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

· The BrainScope One provides a measure of brain function (EEG Brain Function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG).

· BrainScope One also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.

· BrainScope One also stores and displays electronic of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

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.

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Image /page/4/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines under the word. The registered trademark symbol is to the right of the word.

4350 East-West Highway.Suite 1050.Bethesda.Maryland.20814

www.brainscope.com

510(k) SUMMARY1

Submitter:	BrainScope® Company, Inc.4350 East West Highway Suite #1050Bethesda, MD 20814Phone: (240) 752-7680Fax: (240) 752-7679www.brainscope.com
Contact:	Michael E. Singer, Ph.D.Chief Executive OfficerBrainScope Company, Inc.Phone: (240) 752-7677Fax: (240) 752-7679Email: michael.singer@brainscope.com
Prepared By:	Sabyasachi Roy, Ph.D.Director Regulatory Affairs, Quality AssuranceCompliance
Device Proprietary Name:	BrainScope One
Device Common Name:	Brain Injury Adjunctive InterpretiveElectroencephalograph Assessment Aid
Device Classification Name:	Brain Injury Adjunctive InterpretiveElectroencephalograph Assessment Aid
Classification Regulation:	21 CFR § 882.1450
Panel:	Neurology
Product Codes:	PIW, PKQ, OLU
Predicate Device:	Ahead 300 (K161068)

1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c). BrainScope One 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the word "BrainScope" in blue font. There are two horizontal lines above and below the word. The "O" in scope has a brainwave image in the middle of it. There is a registered trademark symbol to the right of the word.

Device Description:

Indications for Use:2

The BrainScope One's Indications for Use are as follows:

BrainScope One is indicated for use as an adjunct to standard clinical practice to . aid in the evaluation of patients who are being considered for a head CT, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15 (including concussion / mild Traumatic Brain Injury (mTBI)), and are between the ages of 18-85 years. BrainScope One should not be used as a substitute for a CT scan.
. The BrainScope One device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope One calculates and displays raw measures for the following standard QEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user.
A negative BrainScope One Structural Injury Classification using brain electrical . activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.
. A positive BrainScope One Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.
An equivocal BrainScope One Structural Injury Classification using brain electrical . activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
BrainScope One provides a measure of brain function (EEG Brain Function Index, .

2 The differences between the BrainScop One and its predicate (Ahead 300) do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. The subject and predicate devices have the same overall intended use.

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Image /page/6/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. The "S" in "Scope" is designed to look like a brainwave. There is a horizontal line above the word "Brain" and below the word "Scope". There is a registered trademark symbol to the right of the word "Scope".

(BFI)) for the statistical evaluation of the human electroencephalogram (EEG).

BrainScope One also provides clinicians with quantitative measures of cognitive . performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.
. BrainScope One also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

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Image /page/7/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines above and below the word. The "o" in "Scope" is replaced with a brainwave symbol. There is a registered trademark symbol to the right of the word.

Table 1: Indications for Use Comparison to Predicate devices

Proposed Device:BrainScope One(K# Not Yet Assigned)	Predicate:Ahead 300(K161068)	Comments
BrainScope One is indicated foruse as an adjunct to standardclinical practice to aid in theevaluation of patients who arebeing considered for a head CT,who sustained a closed headinjury within 72 hours, presentwith a Glasgow Coma Scalescore (GCS) of 13-15 (includingconcussion / mild TraumaticBrain Injury (mTBI)), and arebetween the ages of 18-85years. BrainScope One shouldnot be used as a substitute for aCT scan.	The Ahead 300 is indicated foruse as an adjunct to standardclinical practice to aid in theevaluation of patients who arebeing considered for a headCT, who sustained a closedhead injury within 72 hours,present with a Glasgow ComaScale score (GCS) of 13-15,and are between the ages of18-85 years. The BrainScopeOne should not be used as asubstitute for a CT scan.	Equivalent. Additionalclarification inBrainScope One IFU toaccommodate use of"concussion", "mTBI"across academia, DoD,CDC and FDA.
The BrainScope One device isintended to record, measure,analyze, and display brainelectrical activity utilizing thecalculation of standardquantitative EEG (QEEG)parameters from frontal locationson a patient's forehead. TheBrainScope One calculates anddisplays raw measures for thefollowing standard QEEGmeasures: Absolute andRelative Power, Asymmetry,Coherence and FractalDimension. These raw measuresare intended to be used for posthoc analysis of EEG signals forinterpretation by a qualified user.	The Ahead 300 device isintended to record, measure,analyze, and display brainelectrical activity utilizing thecalculation of standardquantitative EEG (QEEG)parameters from frontallocations on a patient'sforehead. The BrainScope Onecalculates and displays rawmeasures for the followingstandard QEEG measures:Absolute and Relative Power,Asymmetry, Coherence andFractal Dimension. These rawmeasures are intended to beused for post hoc analysis ofEEG signals for interpretationby a qualified user.	Same
A negative BrainScope OneStructural Injury Classificationusing brain electrical activity inpatients who sustained a closedhead injury within 72 hours,likely corresponds to those withno structural brain injury visibleon head CT.	A negative Ahead 300Structural Injury Classificationusing brain electrical activity inpatients who sustained aclosed head injury within 72hours, likely corresponds tothose with no structural braininjury visible on head CT.	Same
A positive BrainScope OneStructural Injury Classificationusing brain electrical activity inpatients who sustained a closed	A positive Ahead 300 StructuralInjury Classification using brainelectrical activity in patientswho sustained a closed head	Same
Proposed Device:BrainScope One(K# Not Yet Assigned)	Predicate:Ahead 300(K161068)	Comments
head injury within 72 hours,likely corresponds to those witha structural brain injury visible onhead CT.	injury within 72 hours, likelycorresponds to those with astructural brain injury visible onhead CT.
An equivocal BrainScope OneStructural Injury Classificationusing brain electrical activity inpatients who sustained a closedhead injury within 72 hours, maycorrespond to structural braininjury visible on head CT or mayindicate the need for furtherobservation or evaluation.	An equivocal Ahead 300Structural Injury Classificationusing brain electrical activity inpatients who sustained aclosed head injury within 72hours, may correspond tostructural brain injury visible onhead CT or may indicate theneed for further observation orevaluation.	Same
BrainScope One provides ameasure of brain function (EEGBrain Function Index, (BFI)) forthe statistical evaluation of thehuman electroencephalogram(EEG).	The Ahead 300 provides ameasure of brain function (EEGBrain Function Index, (BFI)) forthe statistical evaluation of thehuman electroencephalogram(EEG).	Same
BrainScope One also providesclinicians with quantitativemeasures of cognitiveperformance to aid in theassessment of an individual'slevel of cognitive function. Thesemeasures do not interact withany other device measures, andare stand alone.	The Ahead 300 also providesclinicians with quantitativemeasures of cognitiveperformance to aid in theassessment of an individual'slevel of cognitive function.These measures do not interactwith any other devicemeasures, and are stand alone.	Same
BrainScope One also stores anddisplays electronic versions ofstandardized clinical assessmenttools that should be used inaccordance with the assessmenttools' general instructions. Thesetools do not interact with anyother device measures, and arestand alone.	The Ahead 300 also stores anddisplays electronic versions ofstandardized clinicalassessment tools that shouldbe used in accordance with theassessment tools' generalinstructions. These tools do notinteract with any other devicemeasures, and are stand alone.	Equivalent. TheBrainScope Onecontains an expandednumber of standardclinical assessmenttools (library functions).

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Image /page/8/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are lines above and below the word. The letter "C" in scope is stylized to look like a brainwave.

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Image /page/9/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are lines above and below the word. The "O" in scope is replaced with a brainwave graphic. There is a registered trademark symbol to the right of the word.

Comparison of Technological Characteristics with the Predicate Device:

BrainScope One incorporates additional clarification in the Indications for Use statement of its predicate (Ahead 300) to accommodate widely accepted definitions for "concussion" and "mild Traumatic Brain Injury (mTBI)". The core capabilities of BrainScope One and its fundamental scientific technology remain unaltered compared to the Ahead 300 (predicate). The device modifications discussed do not alter the BrainScope One's safety or effectiveness and neither do they change its intended use compared to the Ahead 300 (predicate). BrainScope One is substantially equivalent to the predicate the Ahead 300.

Topic / Area	Proposed Device:BrainScope One	Primary Predicate:Ahead 300	Comments
Platform	Trimble T41 mobiledevice, Android OS	Trimble T41 mobiledevice, Android OS	Same
ProcessedEEGBandwidth	1kHz sampled datawith DC to 300Hzbandwidth and 100Hzsampled data with0.67Hz to 43Hzbandwidth	1kHz sampled data withDC to 300Hz bandwidthand 100Hz sampleddata with 0.67Hz to43Hz bandwidth	Same
CommonModeRejectionRatio (CMRR)	< -100 dB (or better)	< -100 dB (or better)	Same
System NoiseFloor	< 0.4 µV in 0.67 Hz to43Hz bandwidth	< 0.4 µV in 0.3 Hz to43Hz bandwidth	Same
ADCResolution	45 nV/bit	45 nV/bit	Same
ADCSamplingRate	1000 Hz, downsampled to 100 Hz foralgorithm processing	1000 Hz, down sampledto 100 Hz for algorithmprocessing	Same
ElectrodePlacementSystem	The International 10-20 System	The International 10-20System	Same
ElectrodePositionsUtilized	Fp1, Fp2, Fpz, AFz,F7, F8, A1, A2	Fp1, Fp2, Fpz, AFz, F7,F8, A1, A2	Same
ElectrodeMaterial	Single use Ag/AgClelectrode sensor arrayheadset with solid gel	Single use Ag/AgClelectrode sensor arrayheadset with solid gel	Same
Real TimeEEG Display	Yes	Yes	Same
ClassificationAlgorithm(Structural	Three tierclassification withresults of Negative,	Three tier classificationwith results of Negative,Equivocal and Positive	Same

Table 2, Technological Comparison to Predicate Device

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Image /page/10/Picture/0 description: The image shows the word "BRAINSCOPE" in large, bold, blue letters. The letters are slightly stylized, with a line running underneath the word. The "O" in "SCOPE" is replaced with a graphic of a brainwave.

Topic / Area	Proposed Device:BrainScope One	Primary Predicate:Ahead 300	Comments
InjuryClassification)	Equivocal and Positiveoutputs.	outputs.
ResultsPresentationand ReportingFeatures	Specific rawmeasures.EEG playback.Structural injuryclassification and brainfunction index display.Cognitive performanceraw and standardscores includingpercentiles.Electronic versions ofStandard ClinicalAssessments.	Specific raw measures.EEG playback.Structural injuryclassification and brainfunction index display.Cognitive performanceraw and standardscores includingpercentiles.Electronic versions ofStandard ClinicalAssessments.	Equivalent.BrainScope Onehas an expandedlist of libraryfunctions (standardclinicalassessments).

Performance Data:

No clinical or non-clinical performance data was submitted to support the device modification being made. All clinical performance data from the Ahead 300 (predicate) submission still apply.

The BrainScope One device, like its predicate (Ahead 300) is compliant to following standards:

o IEC 60601-1/A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2/A1:2007 Medical electrical equipment Section1.2 o Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1-6/A1:2013 General Requirements For Basic Safety And o Essential Performance - Collateral Standard: Usability
IEC 60601-2-26:2012 Particular requirements for the basic safety and o essential performance of electroencephalographs
ANSI/AAMI EC12:2000/(R)2010 Disposable ECG Electrodes O
ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical devices o Part 1: Evaluation and testing within a risk management process
ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices o Part 5: Tests for In Vitro Cytotoxicity
ANSI/AAMI/ISO 10993-10:2010 Biological evaluation of medical devices o Part 10: Test for irritation and skin sensitization

BrainScope One 510(k) Summary

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Image /page/11/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. The "O" in Scope has a brainwave graphic in the middle of it. There is a registered trademark symbol to the right of the word.

MIL-STD-810G, Department of Defense Test Method Standard for o Environmental Engineering Considerations and Laboratory Tests
IEC 60529 (2004) Degree of Protection Provided by Enclosures o
ASTM D4169 09, Standard Practice for Performance Testing of Shipping o Containers and Systems

Conclusion:

BrainScope One's fundamental scientific technology remain unaltered compared to the predicate (Ahead 300). The device modifications do not alter the BrainScope One's safety or effectiveness and neither do they change its intended use. BrainScope One is substantially equivalent to the predicate the Ahead 300.

Regulation Number and Section

§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.

(a)
Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use.
(6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (
e.g., use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The intended use population and the intended use environment.
(iv) Any instructions technicians should convey to patients regarding the collection of EEG data.
(v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.