The Ahead 300 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, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan.

The Ahead 300 device is intended to record, measure, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The Ahead 300 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 Ahead 300 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 Ahead 300 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 Ahead 300 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 Ahead 300 provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram(EEG).

The Ahead 300 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.

The Ahead 300 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.

Device Description

The Ahead 300 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).

The Ahead 300 is a product of the continual technological evolution of the BrainScope Ahead 200 device. The device platform is essentially identical, and the core capability of the Ahead 300 remains the same as the Ahead 200. Both devices provide an algorithmbased structural injury classification of head injured patients using EEG features. The Ahead 300's accuracy is improved over the Ahead 200. The Ahead 300 also incorporates functions performed by additional legally marketed predicate devices, including an overall assessment of functional brain injury utilizing EEG, and two wellaccepted cognitive performance tests.

AI/ML Overview

While the document mentions that "The co-primary endpoints, as defined by sensitivity and specificity of the study device classification distinguishing CT+ from CT-, successfully exceeded the performance goals, and demonstrated significantly improved performance over Ahead 200," it does not explicitly provide the numerical acceptance criteria or the reported device performance for sensitivity and specificity. It suggests these were successfully met and improved upon the predicate device (Ahead 200).

Therefore, a table of acceptance criteria and reported device performance cannot be generated with the provided information.

However, based on the clinical performance data section, some information regarding the study can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Sensitivity	"Exceeded performance goals"	"Significantly improved performance over Ahead 200"
Specifcity	"Exceeded performance goals"	"Significantly improved performance over Ahead 200"
NPV	Successfully demonstrated	Successfully demonstrated
Repeatability	Successfully demonstrated	Successfully demonstrated
Reproducibility	Successfully demonstrated	Successfully demonstrated

Note: The document states that the co-primary endpoints (sensitivity and specificity) "successfully exceeded the performance goals" and demonstrated "significantly improved performance over Ahead 200". However, the specific numerical values for these performance goals and the achieved performance of the Ahead 300 are not provided in this excerpt.

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

Sample Size: 720 adults
Data Provenance: The document does not explicitly state the country of origin. It mentions "The B-AHEAD III validation trial" and prior "B-AHEAD II validation trial," implying clinical trials. It does not state if the data was retrospective or prospective, but the term "validation trial" typically suggests prospective data collection for evaluating performance.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. It only states that the ground truth for "structural injury" was "visible on head CT."

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It focuses on the device's standalone performance compared to the predicate device (Ahead 200) and other predicates' functionalities.

6. Standalone Performance Study

Yes, a standalone study was done. The "Clinical Performance Data" section describes a "B-AHEAD III validation trial" where the device classification distinguished "CT+ from CT-". This indicates the algorithm's performance independent of human interpretation for the structural injury classification. The document also states "The Ahead 300's accuracy is improved over the Ahead 200," further suggesting standalone comparison.

7. Type of Ground Truth Used

The primary ground truth used for the "Structural Injury Classification" was "structural brain injury visible on head CT."

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. It only mentions the sample size for the validation trial (test set) of 720 adults.

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

The document does not describe how the ground truth for the training set was established. It only refers to the "B-AHEAD III validation trial" which is implied to be the test set, and mentions the ground truth for structural injury classification was based on head CT findings.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2016

Brainscope Company Inc Michael Singer, PhD CEO 4350 East West Highway Suite 1050 Bethesda, Maryland 20814

Re: K161068

Trade/Device Name: Ahead 300 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: August 24, 2016 Received: August 24, 2016

Dear Dr. 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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -A

Carlos L. Peña, PhD, MS for 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) K161068

Device Name Ahead® 300

Indications for Use (Describe)

· The Ahead 300 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, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan.

· The Ahead 300 device is intended to record, measure, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The Ahead 300 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 Ahead 300 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 Ahead 300 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 Ahead 300 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 Ahead 300 provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram(EEG).

· The Ahead 300 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.

· The Ahead 300 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.

Type of Use (Select one or both, as applicable)

X 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 BrainScope. The logo is in blue and features the word "BrainScope" in a bold, sans-serif font. The "C" in "Scope" is stylized with a waveform graphic. There are two horizontal lines underneath the word "BrainScope", and a registered trademark symbol is in the upper right corner of the logo.

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
Date Prepared:	September 20, 2016
Device Proprietary Name:	Ahead® 300
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 Devices:	BrainScope Ahead 200 (K143643)ANAM Test System: Military Battery (K150154)Neurometric Analysis System (K974748)

1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c).

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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. The "W" in scope is replaced with a brainwave symbol. There is a horizontal line above the word "BrainScope" and a registered trademark symbol to the right of the word.

Device Description:

Indications for Use:2

The Ahead 300's Indications for Use reflect the improved performance of the Ahead 300 as compared to the primary predicate, the Ahead 200. The Indications for Use also provide additional information to medical professionals and practitioners upon which they can make more informed decisions about the clinical diagnosis of patients that have sustained a closed head injury, by incorporating relevant portions of the Indications for Use associated with each leqally marketed secondary predicate, thereby improving the overall benefit/risk ratio compared to the predicate devices. As such, the Ahead 300 and the predicate devices are not identical, but the combined set of Indications for Use support the Intended Use of the Ahead 300. The Ahead 300's Indications for Use are as follows:

The Ahead 300 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, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan.
The Ahead 300 device is intended to record, measure, analyze, and display brain o electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The Ahead 300 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.

2 The Ahead 300 is a combination device encompassing indications for use for 3 predicates devices. The Indications for Use statement for the Ahead 300 is a composite of the indications associated with the predicates. The differences do not alter the intended use of the device nor do they affectiveness of the device relative to the predicates. The subject and predicate devices have the same overall intended use.

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Image /page/5/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 above and below the word. The letter "O" in "Scope" is replaced with a brainwave graphic.

A negative Ahead 300 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 Ahead 300 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 Ahead 300 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 Ahead 300 provides a measure of brain function (EEG Brain Function Index. . (BFI)) for the statistical evaluation of the human electroencephalogram (EEG).
o The Ahead 300 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.
The Ahead 300 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/6/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a bold, sans-serif font. There are two horizontal lines above and below the word. The "W" in the middle of the word is replaced by a brainwave symbol.

Table 1: Indications for Use Comparison to Predicate devices

Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM TestSystem -Military Battery	SecondaryPredicate:NeurometricAnalysis System	Comments
The Ahead 300 isindicated for use asan adjunct tostandard clinicalpractice to aid inthe evaluation ofpatients who arebeing consideredfor a head CT,sustained a closedhead injury within72 hours, presentwith a GlasgowComa Scale score(GCS) of 13-15,and are betweenthe ages of 18-85years. The Ahead300 should not beused as asubstitute for a CTscan.	The Ahead 200,consisting of twomodels, i.e., theAhead M-200and the AheadCV-200, isindicated for useas an adjunct tostandard clinicalpractice to aid inthe evaluation ofpatients who arebeing consideredfor a head CT,but should not beused as asubstitute for aCT scan. Thisdevice is to beused for thispurpose inpatients whosustained aclosed headinjury within 24hours, clinicallypresent as a mildtraumatic braininjury with aGlasgow ComaScale score(GCS) of 13-15,and are betweenthe ages of 18-80 years.	N/A	N/A	Equivalent to primarypredicate, withmodificationsreflecting the Ahead300 clinical trialresults, including:· an expanded injurytime window (72hours versus 24hours for the Ahead200),· an expanded patientage range (18-85years versus 18-80years for the Ahead200).
The Ahead 300device is intendedto record, measure,analyze, anddisplay brainelectrical activityutilizing thecalculation ofstandardquantitative EEG	The Ahead 200device isintended torecord, measure,analyze, anddisplay brainelectrical activityutilizing thecalculation ofstandard	N/A	N/A	Same as primarypredicate.
Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM TestSystem –Military Battery	SecondaryPredicate:NeurometricAnalysis System	Comments
(QEEG)parameters fromfrontal locations ona patient'sforehead. TheAhead 300calculates anddisplays rawmeasures for thefollowing standardQEEG measures:Absolute andRelative Power,Asymmetry,Coherence andFractal Dimension.These rawmeasures areintended to beused for post hocanalysis of EEGsignals forinterpretation by aqualified user.	quantitative EEG(QEEG)parameters fromfrontal locationson a patient'sforehead. TheAhead 200calculates anddisplays rawmeasures for thefollowingstandard QEEGmeasures:Absolute andRelative Power,Asymmetry,Coherence andFractalDimension.These rawmeasures areintended to beused for post hocanalysis of EEGsignals forinterpretation bya qualified user.	N/A	N/A
A negative Ahead300 StructuralInjury Classificationusing brainelectrical activity inpatients whosustained a closedhead injury within72 hours, likelycorresponds tothose with nostructural braininjury visible onhead CT.	A negativeBrainScopeClassificationmay correspondto brain electricalactivityconsistent withno structuralbrain injuryvisible on headCT in patientspresenting as amild traumaticbrain injury.	N/A	N/A	Equivalent to primarypredicate, withproposed changes inthe Ahead 300language reflectingthe significantlyimproved accuracydemonstrated by theAhead 300 trialresults.
A positive Ahead300 StructuralInjury Classificationusing brain	A positiveBrainScopeClassificationcorresponds to	N/A	N/A	Equivalent to primarypredicate, withproposed changes inthe Ahead 300
Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM TestSystem –Military Battery	SecondaryPredicate:NeurometricAnalysis System	Comments
electrical activity inpatients whosustained a closedhead injury within72 hours, likelycorresponds tothose with astructural braininjury visible onhead CT.	brain electricalactivity that maybe present inboth patientswith or without astructural braininjury visible onhead CT. ApositiveBrainScopeClassificationdoes notestablish thepresence of astructural braininjury visible onhead CT.			language reflectingthe improvedaccuracydemonstrated by theAhead 300.In addition, thestatement regardingfalse positives in theIFU of the predicateis now expanded andmoved to the SafetySummary section ofthe User Manual.
An equivocalAhead 300Structural InjuryClassification usingbrain electricalactivity in patientswho sustained aclosed head injurywithin 72 hours,may correspond tostructural braininjury visible onhead CT or mayindicate the needfor furtherobservation orevaluation.	N/A	N/A	N/A	The Ahead 200 hasno equivocal zone.This zone has beenadded to provideadditional clinicalinformation to theclinician for use in thediagnostic process,providing informationabout patients whoare close to thebinary threshold forclassification.
The Ahead 300provides ameasure of brainfunction (EEGBrain FunctionIndex, (BFI)) for thestatisticalevaluation of thehumanelectroencephalogram (EEG).	N/A	N/A	The NeurometricAnalysis systemis to be used byqualified medicalprofessionals forthe post-hocstatisticalevaluation of thehumanelectroencephalogram (EEG).	The Ahead 300 andNAS both usemultivariatecomposite featuresas a measure ofabnormality of overallbrain function relativeto age expectednormal values, andthe functionality isconsistent with theintended use of
Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM TestSystem -Military Battery	SecondaryPredicate:NeurometricAnalysis System	Comments
				analyzing a patient'selectroencephalograph (EEG) to providean interpretation ofthe patient'sneuropsychiatriccondition, as well asto record, measure,and display brainelectrical activity.Removal of "post-hoc" analysis reflectsthe advances intechnology allowingfor real-time analysison the device, butdoes not changefunctionality.
The Ahead 300also providesclinicians withquantitativemeasures ofcognitiveperformance to aidin the assessmentof an individual'slevel of cognitivefunctioning. Thesemeasures do notinteract with anyother devicemeasures, and arestand alone.	N/A	The ANAMTest System:MilitaryBatteryprovidesclinicians withobjectivemeasurements of cognitiveperformancein militarypopulationsages 18 to 65years, to aidin theassessmentof anindividual'slevel ofcognitivefunctioning.The ANAMTest Systemshould onlybe used as anadjunctivetool for	N/A	Equivalent tosecondary predicate.
Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM TestSystem –Military Battery	SecondaryPredicate:NeurometricAnalysis System	Comments
		evaluatingcognitivefunction.
The Ahead 300also stores anddisplays electronicversions ofstandardizedclinical assessmenttools that should beused in accordancewith theassessment tools'generalinstructions. Thesetools do not interactwith any otherdevice measures,and are standalone.	The Ahead M-200 modeladditionallystores anddisplays anelectronicversion of theMilitary AcuteConcussionEvaluation(MACE)cognitiveassessment anduser-enteredresponses to theMACE questions.There is nointeractionbetween EEG-relatedfunctionality,includinganalyzing anddisplaying brainelectrical activity,and the functionof storing anddisplaying MACEinformation.	N/A	N/A	Equivalent to primarypredicate. IFUlanguage isgeneralized to reflectthe fact that theAhead 300 storesand displays multipleassessment tools aspart of its libraryfunction. Users willknow the fullcapability of theAhead 300 from theUser Manual.
Topic / Area	Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM Test System:Military Battery	SecondaryPredicate:NeurometricAnalysisSystem
Platform	Trimble T41 mobiledevice, Android OS	Trimble T41 mobiledevice, Android OS	PC: Dell LatitudeE6440 LaptopComputer, two buttonUSB connectedmouse, and Windows7 Operating System	Stand-alonepost hocanalysissoftware thatmay be run onIBM-compatiblecomputersystems.
ProcessedEEGBandwidth	1kHz sampled datawith DC to 300Hzbandwidth and100Hz sampleddata with 0.67Hz to43Hz bandwidth	1kHz sampled datawith DC to 300Hzbandwidth and100Hz sampleddata with 0.3Hz to43Hz bandwidth	N/A	N/A
CommonModeRejectionRatio (CMRR)	< -100 dB (orbetter)	< -100 dB (orbetter)	N/A	N/A
System NoiseFloor	< 0.4 µV in 0.67 Hzto 43Hz bandwidth	< 0.4 µV in 0.3 Hzto 43Hz bandwidth	N/A	N/A
ADCResolution	45 nV/bit	45 nV/bit	N/A	N/A
ADC SamplingRate	1000 Hz, downsampled to 100 Hzfor algorithmprocessing	1000 Hz, downsampled to 100 Hzfor algorithmprocessing	N/A	N/A
Wireless data	No wirelesscommunication	No wirelesscommunication	N/A	N/A
Topic / Area	Proposed Device:Ahead 300	PrimaryPredicate:Ahead 200	SecondaryPredicate:ANAM Test System:Military Battery	SecondaryPredicate:NeurometricAnalysisSystem
transmission	capability.	capability
ElectrodePlacementSystem	The International10-20 System	The International10-20 System	N/A	N/A
ElectrodePositionsUtilized	Fp1, Fp2, Fpz,AFz, F7, F8, A1, A2	Fp1, Fp2, Fpz,AFz, F7, F8, A1, A2	N/A	N/A
ElectrodeMaterial	Single use Ag/AgClelectrode sensorarray headset withsolid gel	Single use Ag/AgClelectrode sensorarray headset withsolid gel	N/A	N/A
Real TimeEEG Display	Yes	Yes	N/A	N/A
ClassificationAlgorithm(StructuralInjuryClassification)	Three tierclassification withresults of Negative,Equivocal andPositive outputs.	Two tierclassificationclassifier withresults of Positiveor Negativeoutputs.	N/A	N/A
ResultsPresentationand ReportingFeatures	Specific rawmeasures.EEG playback.Structural injuryclassification andbrain function indexdisplay.Cognitiveperformance rawand standardscores includingpercentiles.Electronic versionsof Standard ClinicalAssessments.	Specific rawmeasures.EEG playback.Structural injuryclassificationElectronic versionof the Military AcuteConcussionEvaluation (MACE)results.	Provides raw scores,standard scores andpercentiles (calculatedwith normativedatabase) for eachtest. Also yields theANAM CompositeScores (ACS)summarizingperformance acrossthe test battery.	Output includesz-scores,standarddeviations andmultivariatecombinations ofz-scores and"hits" presentedin tabularformat.

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Image /page/7/Picture/0 description: The image shows the word "BRAINSCOPE" in a stylized, blue font. The letters are bold and slightly italicized, with a horizontal line above and below the word. The "O" in "SCOPE" is replaced with a graphic of brainwaves, and there is a registered trademark symbol to the right of the word.

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Image /page/8/Picture/0 description: The image shows the logo for BrainScope. The word "BRAINSCOPE" is written in large, bold, blue letters. There are two horizontal lines above and below the word. The "O" in "SCOPE" is stylized to look like a brainwave.

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Image /page/9/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" is stylized to look like a brainwave. There is a registered trademark symbol to the right of the word.

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Image /page/10/Picture/0 description: The image shows the word "BRAINSCOPE" in a stylized blue font. The word is written in all capital letters, and there are two horizontal lines above and below the word. The letter "O" in "SCOPE" is stylized to look like a brainwave. There is a registered trademark symbol to the right of the word.

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Image /page/11/Picture/0 description: The image is a logo for BrainScope. The logo is in blue and features the word "BrainScope" in a bold, sans-serif font. There are two horizontal lines above and below the word "BrainScope". The "O" in "Scope" has a waveform graphic inside of it. There is a registered trademark symbol to the right of the word "BrainScope".

Comparison of Technological Characteristics with the Predicate Devices:

While there are differences in technological characteristics when comparing the Ahead 300 with the predicate devices, the differences do not raise different questions of safety and effectiveness.

The core capability of the Ahead 300 remains the same as the Ahead 200. The device hardware and electrode headset are essentially identical. The device software (including algorithms) is based on the same fundamental architecture/platform with expanded scope to incorporate additional functionalities.

The technological characteristics associated with the additional capability to perform two well-accepted standard Cognitive Performance tests are equivalent to the ANAM Test System: Military Battery, and the technological characteristics associated with the Brain Function Index are equivalent to those of the Neurometric Analysis System.

Table 2, Technological Comparison to Predicate Devices

Ahead® 300 510(k) Summary

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Image /page/12/Picture/0 description: The image shows the word "BRAINSCOPE" in blue font. The letters are bold and have a horizontal line above and below them. There is a registered trademark symbol to the right of the word "BRAINSCOPE".

Non-Clinical Performance Data:

The following non-clinical tests were performed to support the determination of substantial equivalence:

Bench testing including device software (including algorithms), hardware o (including disposable electrode headset), and systems.
In addition, testing was performed as per the following performance standards: .

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Image /page/13/Picture/0 description: The image is a logo for BrainScope. The word "BrainScope" is written in large, bold, blue letters. There are two blue lines, one above and one below the word. The letter "S" in "BrainScope" has a waveform in the middle of it. There is a registered trademark symbol to the right of the word.

IEC 60601-1/A1:2012 Medical Electrical Equipment Part 1: General o 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
o IEC 60601-1-6/A1:2013 General Requirements For Basic Safety And 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
o ANSI/AAMI/ISO 10993-5:2009 Biological Evaluation of Medical Devices 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
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 o Shipping Containers and Systems

The results of the non-clinical (bench) testing demonstrate that the Ahead 300 meets or exceeds the performance of the predicate devices. The technological differences between the Ahead 300 and the predicates do not raise different questions of safety or effectiveness.

Clinical Performance Data:

The target population of the B-AHEAD III validation trial was aligned with that of the B-AHEAD II validation trial for the predicate device Ahead 200, and consisted of 720 adults; 60.7% males, mean age of 43.12 years, mean GCS of 14.97 and an average time since injury of 13.9 hours.

The co-primary endpoints, as defined by sensitivity and specificity of the study device classification distinguishing CT+ from CT-, successfully exceeded the performance goals, and demonstrated significantly improved performance over Ahead 200. A high negative predictive value (NPV), and repeatability and reproducibility of the device result were also successfully demonstrated.

The secondary endpoints reflect the evolution of the Ahead system, providing additional quantitative information about brain function using the EEG Brain Function Index which Ahead® 300 510(k) Summary

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scales with severity of functional impairment, and reducing the risk of false negatives through the addition of the Equivocal Zone for classification of structural TBI. The Ahead 300 validation trial achieved secondary endpoints related to these two functionalities.

The Ahead 300 clinical validation trial successfully achieved its target performance, and demonstrating enhanced performance compared to the Ahead 200.

Conclusion:

The Ahead 300 is a product of the continual technological evolution of the previously FDA cleared Ahead 200 device. The Ahead 300 is a "combination device" that incorporates additional capabilities associated with the legally marketed ANAM Test System: Military Battery and the Neurometric Analysis System.

The Ahead 300 has the same intended use as the Ahead 200, the ANAM Test System: Military Battery, and the Neurometric Analysis System. The Ahead 300's Indications for Use statement has been modified to incorporate the relevant portions of the indications associated with each legally marketed predicate device and the slight differences do not alter the device's intended use, nor do they affect the safety and effectiveness of the device relative to the predicates.

The technological characteristics of the Ahead 300 are very similar to the previously FDA cleared Ahead 200, with the additional information generating capabilities of the legally marketed ANAM Test System: Military Battery and the Neurometric Analysis System.

The technological characteristics of the Ahead 300 when compared to the predicate devices do not raise new questions of safety or effectiveness, and sufficient non-clinical performance data and clinical performance data has been provided to demonstrate that the Ahead 300 is as safe and effective as the predicate devices.

The Ahead 300 is substantially equivalent to the Ahead 200, and the legally marketed ANAM Test System: Military Battery and the Neurometric Analysis System.

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.