• The Ahead® 200, consisting of two models, i.e., the Ahead® CV-200, 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, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years.

· A negative BrainScope® Classification may correspond to brain electrical activity consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury.

· A positive BrainScope® Classification corresponds to brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT.

· The Ahead® 200 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® 200 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.

• The Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including and displaying brain electrical activity, and the function of storing and displaying MACE information.

· The Ahead® 200 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the device.

• The Ahead® 200 is a prescription use device.

Device Description

BrainScope® Ahead® 200 is a Brain Injury Adjunctive The Interpretive Electroencephalograph Assessment Aid, Class II device. It is a portable, non-sterile, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) device and is intended to provide an objective assessment of brain electrical activity associated with traumatic brain injury (TBI). This 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.

The BrainScope® Ahead® 200 is comprised of two hardware components: the Handheld Device and the disposable Electrode Headset with patient application supplies. The main software components of the Ahead 200 are the application software and the BrainScope Algorithm Library (BSAL). The Ahead® 200 has two models: (1) the Ahead® M-200, which is intended for use by the military, and (2) the Ahead® CV-200, which is intended for civilian use. The Ahead® M-200 and the Ahead® CV-200 have the same indications for use and intended uses with the exception that the Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information. The Ahead® M-200 and the Ahead® CV-200 have identical technological characteristics except that the Ahead® M-200 contains the additional MACE feature, i.e., an electronic version of the paper and pencil based MACE.

AI/ML Overview

This document is a 510(k) premarket notification for the BrainScope Ahead 200 device, asserting its substantial equivalence to a predicate device, the BrainScope Ahead 100. It focuses on device specifications, safety, and performance comparisons rather than detailed clinical acceptance criteria and a definitive study demonstrating them.

Here's an analysis based on the provided text, outlining the limitations due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) for the Ahead 200 device. Instead, it focuses on verifying that the Ahead 200 functions as intended and is comparable to its predicate device. The performance data presented are primarily engineering and safety tests:

Design Verification Test	Result
Software (including User Interface) Verification Testing	Pass
Hardware Verification	Pass
System Performance and Functionality	Pass
Algorithm Performance	Pass
Packaging Testing	Pass
Basic Safety and Essential Performance (IEC 60601-1, 3rd ed.) including PEMS clause 14 for Software	Pass
Electromagnetic Compatibility	Pass
Biocompatibility	Pass
Reliability	Pass

The document asserts the "Algorithm Performance" passed, and that the "Harmony" classification algorithm used is the same as the predicate device, implying its performance is at least equivalent. However, specific performance metrics (sensitivity, specificity) of this algorithm are not provided in this document.

Similarly, electrical hardware specifications are compared, suggesting functional acceptance criteria for components:

Electrical Hardware Feature	Ahead® 200 Performance	Comparable Predicate Ahead® 100 Performance	Note (Indicating improvement or equivalence)
Common Mode Rejection Ratio (CMRR)	< -100 dB	< - 85 dB	Ahead® 200 better CMRR
Low pass filtering prior to signal processing	0.3 Hz to 43Hz	0.3 Hz to 43Hz	Same
System Noise Floor	< 0.4 µV in 0.3 Hz to 43Hz bandwidth	< 0.4 µV in 0.3 Hz to 43Hz bandwidth	Same
ADC Resolution	45 nV/bit	31.2nV/bit	Both devices have better resolution than their noise floor
ADC Sampling Rate	1000 Hz, down sampled to 100 Hz for algorithm processing	1000 Hz, down sampled to 100 Hz for algorithm processing	Processing bandwidth used by algorithm is same
Data Channel	7	7	Same

The clinical "acceptance criteria" for the device, in terms of diagnostic accuracy, would typically have been established during the clearance of the predicate device (Ahead 100), as this submission for Ahead 200 claims "substantial equivalence" based on using the "Same Harmony algorithm" and "Same fundamental technology." This document does not present a new clinical study to establish these criteria for the Ahead 200 itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document for the clinical performance of the classification algorithm. The document states that "All tests were conducted on the new model to establish substantial equivalence to the predicate (Ahead® 100, models M-100 and CV-100, DEN 140025)." These are primarily engineering and functionality tests. Any clinical performance data regarding the "Harmony" algorithm would likely be referenced in the predicate device's 510(k) (DEN 140025), which is not part of this input.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document as it focuses on engineering and functional testing for equivalence. For the clinical performance of the classification algorithm, ground truth (e.g., presence/absence of structural brain injury on head CT) would have been established for the studies that supported the predicate device's clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of an MRMC comparative effectiveness study in this document. The device is a "Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid," meaning it's intended to aid in evaluation, not directly replace or be compared in an MRMC setting with human readers. It's an algorithm generating a "classification" based on EEG, which is then used by a physician.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "Algorithm Performance" as a test that passed. The "BrainScope® Classification" (positive/negative) output by the device is described as "brain electrical activity consistent with no structural brain injury visible on head CT" or "brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT." This implies a standalone classification from the algorithm. However, quantitative performance metrics (e.g., sensitivity, specificity, PPV, NPV) of this standalone classification are not explicitly provided in this document. Any such data would likely be found in the original 510(k) for the predicate device, as this device uses the "Same Harmony algorithm."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "Indications for Use" mention "structural brain injury visible on head CT." This strongly implies that the ground truth for assessing the algorithm's performance (implicitly for the predicate device, as the algorithm is the same) was based on head CT scans.

8. The sample size for the training set

The document does not provide the sample size for the training set for the "Harmony" algorithm. This information would typically be part of the development and validation of the algorithm, likely detailed in the predicate device's 510(k) submission.

9. How the ground truth for the training set was established

The document does not provide this information. Given the ground truth type mentioned (structural brain injury visible on head CT), it would logically have involved interpretation of head CT scans.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing to the right. The profiles are connected by a flowing line that forms the shape of a bird.

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

May 15, 2015

BrainScope Company, Inc. Michael Singer President and CEO 4350 East-West Highway Suite 1050 Bethesda, MD 20814

Re: K143643

Trade/Device Name: BrainScope Ahead 200 (models M-200 and CV-200) Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW Dated: April 15, 2015 Received: April 15, 2015

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 with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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" (21CFR 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.

for

Sincerely yours,

Felipe Aquel -S

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) K143643

Device Name BrainScope Ahead 200 (models M-200 and CV-200)

Indications for Use (Describe)

· The Ahead® 200 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the device.

• The Ahead® 200 is a prescription use device.

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)

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 word "BRAINSCOPE" is written in large, bold, blue letters. There are two horizontal blue lines above and below the word. The "O" in "SCOPE" has a waveform in it, and there is a registered trademark symbol to the right of the word.

4350 East-West Highway.Suite 1050.Bethesda.Maryland.20814 www.brainscope.com phone 240.752.7680

Premarket Notification 510(k) Summary [Ahead® 200]

510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Submitter's Name andAddress:	BrainScope Company, Inc.4350 East West Highway Suite #1050Bethesda, Maryland 20814Telephone Number: (240) 752-7680Fax Number: (240) 752-7679
Company Contact PersonPhone:Fax:Email:	Michael E. Singer, Ph.D., President and CEO(240) 752-7680(240) 752-7679michael.singer@brainscope.com
Submission CorrespondentPhone:Fax:Email:	Michael E. Singer, Ph.D., President and CEO(240) 752-7680(240) 752-7679michael.singer@brainscope.com
Device Name	BrainScope® Ahead® 200 (Models M-200 and CV-200)
Regulation Name	Brain Injury Adjunctive InterpretiveElectroencephalograph Assessment Aid
Regulation Number	21 CFR 882.1450
Classification	Class II
Product Code	PIW
Predicate Device	BrainScope® Ahead® 100 (Models M-100 and CV-100)(DEN 140025)
Date of Submission	December 22, 2014

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1. Description of the Device

The Ahead® 200 has the following similarities to the cleared predicate device:

. Same intended use
Same operating principle ●
Same fundamental scientific technology .
Same algorithm software

2. Intended Use of the Device

. The Ahead® 200, with models M-200 and CV-200, 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, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years.
A negative BrainScope® Classification may correspond to brain electrical activity ● consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury.

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A positive BrainScope® Classification corresponds to brain electrical activity that may . be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT.
The Ahead® 200 is intended to record, measure, analyze, and display brain electrical . activity utilizing the calculation of standard quantitative EEG (gEEG) parameters from frontal locations on a patient's forehead. The Ahead® 200 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.
The Ahead® M-200 model additionally stores and displays an electronic version of ● the Military Acute Concussion Evaluation (MACE) cognitive assessment and userentered responses to the MACE questions. There is no interaction between EEGrelated functionality, including analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information.
The Ahead® 200 is intended for use by physicians, or under the direction of a . physician, who have been trained in the use of the device.
The Ahead® 200 is a prescription use device. ●

3. Summary of Performance Data and Substantial Equivalence

The Ahead® 200, models M-200 and CV-200, was designed and verified in accordance with the risk analysis and product requirements. All tests were conducted on the new model to establish substantial equivalence to the predicate (Ahead® 100, models M-100 and CV-100, DEN 140025). The Ahead® 200, models M-200 and CV-200, was tested and shown to be compliant with the following standards:

1. ANSI/AAMI ES60601-1:2005/(R)2012 "Medical electrical equipment Part 1: General requirements for basic safety and essential performance"
1. CAN/CSA C22.2 No 601.1-08(R2013), "Medical Electrical Equipment, Part 1: General Requirements for Safety"
1. IEC/EN 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (including PEMS clause 14)
1. IEC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
1. IEC/EN 60601-1-2:2007 Medical electrical equipment Section1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests
1. ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
1. ANSI/AAMI EC12:2000 Disposable ECG Electrodes

The following testing was conducted to demonstrate the safety and efficacy of the Ahead® 200, Models M-200 and CV-200, in its intended environment.

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Table 1.0 – Design Verification Test

Design Verification Test	Result
Software (including User Interface) VerificationTesting	Pass
Hardware Verification	Pass
System Performance and Functionality	Pass
Algorithm Performance	Pass
Packaging Testing	Pass
Basic Safety and Essential Performance (IEC60601-1, 3rd ed.) including PEMS clause 14 forSoftware	Pass
Electromagnetic Compatibility	Pass
Biocompatibility	Pass
Reliability	Pass

This 510(k) submission represents the results of the testing and the detailed description to demonstrate that the Ahead® 200, models M-200 and CV-200, is substantially equivalent to the Ahead® 100, models M-100 and CV-100 (DEN 140025).

The table 2.0 below provides a design comparison of the Ahead® 200 to the predicate Ahead® 100 (DEN 140025)

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	Ahead® 200, models M-200 and CV-200	Ahead® 100, models M-100 and CV-200(Predicate Device,DEN100425)	Notes
Major SystemComponents	1. Handheld computerand DAB2. Disposable ElectrodeHeadset3. Software4. Algorithm5. Accessories	1. Handheld Unitincluding patientinterface cable2. Disposable ElectrodeHeadset3. Software4. Algorithm5. Accessories	Same
Components Physical Dimension
Device Size(mm)	Handheld Unit: 90x165x30Data Acquisition Board(DAB): 130x110x50	114x200x51	Ahead® 200handheld issmaller andDAB isergonomic
Weight	Max 0.620kg (1.4 lbs.)	Max 1.4kg (2.5lbs)	Ahead® 200 islighter
Ingress Protection and Operational Environment
IngressProtection	IP54 minimum as per IEC60529	IP4X as per IEC 60529	Ahead® 200 ismuch betterprotected fromsolid and liquidingress
OperationalTemperature	0°C to 38°C (32°F to100°F)	0°C to 50°C (32°F to122°F)	Ahead 100 haswider range butboth devicesmeet productrequirements
Electrical Hardware
	Ahead® 200, models M-200 and CV-200	Ahead® 100, models M-100 and CV-200(Predicate Device,DEN100425)	Notes
Location ofAnalog to DigitalConversion(ADC)	Immediately afterElectrode Headset	After patient interfacecable	Ahead® 200signal chain ismore immuneto noise
Common ModeRejection Ratio(CMRR)	< -100 dB	< - 85 dB	Ahead® 200better CMRR
Low passfiltering prior tosignalprocessing	0.3 Hz to 43Hz	0.3 Hz to 43Hz	Same
System NoiseFloor	< 0.4 µV in 0.3 Hz to 43Hzbandwidth	< 0.4 µV in 0.3 Hz to 43Hzbandwidth	Same
ADC Resolution	45 nV/bit	31.2nV/bit	Both deviceshave betterresolution thantheir noise floor
ADC SamplingRate	1000 Hz, down sampled to100 Hz for algorithmprocessing	1000 Hz, down sampledto 100 Hz for algorithmprocessing	Processingbandwidth usedby algorithm issame
Data Channel	7	7	Same
Storage Capacity
Total Capacity	32 GB in micro-SD card	4 GB in CF card	Ahead® 200has significantlymore storagememory space
Battery
BatteryChemistry	Li-ion rechargeable batterypack	Li-ion rechargeablebattery pack	Same
Battery Run-Time	Minimum of 10 patientrecordings sessions in onecharge. Equivalent of 120minutes of effectiveoperation.	Minimum of 140 minutesof effective operation.	Ahead® 100 isbetter in rawnumbers butboth devicesmeetrequirement.
BatteryLongevity	1-2 years of service beforereplacement	1-2 years of servicebefore replacement	Same
	Ahead® 200, models M-200 and CV-200	Ahead® 100, models M-100 and CV-200(Predicate Device,DEN100425)	Notes
Battery SafetyConsiderations	IEC 60950-1:2005compliant.Evaluated as part of IEC60601-1 certification	The battery pack isequipped with a thermalprotection device toprevent excess chargeand discharge currents.Battery and battery packsafety evaluated as part ofIEC 60601-1 certification.	Verificationmethodologywas different asdata on Ahead®100 batterypack waslimited. Ahead®200 battery isfully certifiedand did notrequireadditionaltesting.
BatteryCharging	Full recharge in less than4 hours in device turnedoff mode	Full recharge in less than3.5 hours in device turnedoff mode	Ahead® 200battery takes 30minutes moreto charge.
Accessories	Battery charger andcharging cable	Battery charger andcharging cable	Actual batterycharger andcables aredifferent as theinterfaceconnectors andbattery packsare different.Accessories forboth devicesare fullycompliant toIEC 60601-1.
Electrode Headset
ElectrodePlacementSystem	The International 10-20System is used as a basisfor electrode placement.	The International 10-20System is used as a basisfor electrode placement.	Same
ElectrodePositions Utilized	Fp1, Fp2, Fpz, AFz, F7,F8, A1, A2	Fp1, Fp2, Fpz, AFz, F7,F8, A1, A2	Same
	Ahead® 200, models M-200 and CV-200	Ahead® 100, models M-100 and CV-200(Predicate Device,DEN100425)	Notes
ElectrodeMaterial	Single use Ag/AgClelectrode sensor arrayheadset with solid gel	Single use Ag/AgClelectrode sensor arrayheadset with wet gel	Difference inthe electrolyticgel material.Despitedifference bothelectrodes meetANSI/AAMIEC12 standardfor electrodeelectricalperformance.
ElectrodeImpedance Test	Yes, at start of recordingand during recording	Yes, at start of recording	Ahead® 200provides betterusability anddata quality byperformingcontinuous outof (EEG) bandimpedancemeasurement.
HeadsetAuthentication	Yes. Ahead 200 utilizeshardware based headsetauthentication.	No such authentication ispossible on the Ahead100.	Ahead® 200provides betterusability anddata quality byensuring use ofapprovedheadsets.
System Software and Algorithms
OperatingSystem	Android	MontaVista Linux	Ahead® 200utilizes amodern andupdated mobileOS comparedto the Ahead100.
	Ahead® 200, models M-200 and CV-200	Ahead® 100, models M-100 and CV-200(Predicate Device,DEN100425)	Notes
Graphical UserInterface -Screens	Patient InformationElectrode ImpedanceRaw EEG WaveformDashboard ScreenGCS score and warningIFU warningsClassification ResultsData Review screenMACE (military version)	Patient InformationElectrode ImpedanceRaw EEG WaveformGCS score and warningIFU warningsClassification ResultsData Review screenMACE (military version)	Ahead® 200improvesusability byincluding theDashboardscreen. TheDashboardscreen givesthe user real-time indicationof the progressof on-goingEEG recording.
Encryption	AES-128 for intra-devicecommunication	None for intra-devicecommunication	Ahead® 200has enhancedencryption
AutomaticArtifacting	8 types of artifactdetection	8 types of artifactdetection	Same
ClassificationAlgorithm	Harmony	Harmony	Same
Real Time EEGDisplay	Yes	Yes	Same
Data Analysis	●Conversion from timedomain to frequencydomainDerivation of multiple●features such asabsolute power,relative power,coherence, etc.Calculation of a●discriminant functionfor structural injury	Conversion from time●domain to frequencydomainDerivation of multiple●features such asabsolute power,relative power,coherence, etc.Calculation of a●discriminant functionfor structural injury	Same
	Ahead® 200, models M-200 and CV-200	Ahead® 100, models M-100 and CV-200(Predicate Device, DEN100425)	Notes
ResultsPresentation	Positive and Negative BrainScope classification as described in IFU Display screens with information on specific raw measures EEG playback The Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment	Positive and Negative BrainScope classification as described in IFU Display screens with information on specific raw measures EEG playback The Ahead® M-100 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment	Same
Compliance to Standards
ISO 14971: 2000RiskManagement	Yes	Yes	Same
ISO 10993-1:2009 -Biologicalevaluation ofmedical devices	Yes	Yes	Same
ANSI/AAMIEC12:2000	Yes	Yes	Same
IEC60601-1 -Generalrequirements forbasic safety andessentialperformance	Yes, for 3rd edition	Yes, for 2nd edition	Ahead® deviceswere compliantto recognizedconsensusversions at thetime ofsubmission
	Ahead® 200, models M-200 and CV-200	Ahead 100, models M-100 and CV-200(Predicate Device,DEN100425)	Notes
IEC 60601-1-2:2007Requirements forSafety -CollateralStandard:ElectromagneticCompatibility -Requirementsand Tests	Yes	Yes	Same
IEC 60601-2-26:ParticularRequirements forthe Safety ofElectro-encephalographs	Yes, compliant with 2012version	Yes, compliant with 2002version (for use with 2nded.)	Ahead® 200compliant withupdated versionof standard
ASTM D4169-09,performance ofpackaging	Yes, compliant to DC 13,AL 1	Yes, compliant to DC 13,AL 2	Ahead® 200compliant tostricter limits onsame tests.

Table 2.0 Comparison between Ahead® 200 & the predicate device Ahead® 100

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The table 3.0 below provides a comparison summary of the features of Ahead® 200 to the predicate device, the Ahead® 100.

Table 3.0 Comparison Summary of Features

Functional Features	Same/Different
Indications	Same
Technology	Same fundamentaltechnology with currentfaster operating system
Software Algorithm	Same Harmony algorithm

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Functional Features	Same/Different
User Interface	Same features but Ahead®200 has improved usabilityby including the Dashboardscreen.
	The Dashboard screengives the user real-timeindication of the progress ofon-going EEG recording.

4. Conclusion

The information and data provided in this 510(k) notification establishes that the Ahead® 200, with models M-200 and CV-200, is substantially equivalent to the currently cleared device Ahead® 100, models M-100 and CV-100. The intended use is identical to the predicate device. The proposed device Ahead® 200 shares the basic design and fundamental operating principles to the currently cleared device (Ahead® 100, DEN 140025).

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.