This software-only component of an EEG biofeedback system uses industry-accepted standard Microsoft Windows-based computers to accept EEG data from external FDAapproved amplifier/encoders and provide biofeedback information. The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data. The device processes EEG information, separates it into user-specified frequency bands, and displays the results as biofeedback indications to a user.

AI/ML Overview

The provided 510(k) summary for EEGer4 does not contain the kind of detailed study information typically requested for AI/ML-based medical devices or those requiring performance validation against acceptance criteria. This submission is for a much simpler software-only device that processes EEG data for biofeedback, without making diagnostic claims.

Therefore, many of the requested categories cannot be answered from the provided text. The device's "performance" is primarily described by its specifications and comparison to predicate devices, rather than a clinical study establishing diagnostic accuracy.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, a software-only EEG biofeedback system, the "acceptance criteria" are implied by its functional specifications and substantial equivalence to predicate devices, rather than specific accuracy metrics for a diagnostic task. The performance revolves around its ability to process EEG data and display biofeedback.

Acceptance Criteria Category	EEGer4 Reported Performance/Description
Intended Use	General relaxation training when used with supported amplifier/encoders.
Software Name	EEGer4
Supported Devices	Mfr: Brainmaster (Brainmaster 2E, Atlantis versions), Mfr: Thought Technology (ProComp versions, Infiniti versions, Flexcomp), Mfr: J&J Engineering (C2 versions, C2+ versions), Mfr: Telediagnostics (A200 versions, A400 versions)
Operating System	Microsoft Windows (XP and later)
Computer	Generic PC computer supported by Microsoft Windows
Sampling Rate	256 Hz
Number of EEG Channels	4
Bandwidth	0 - 50 Hz
Filtering	Digital Filters
Device Interface	Depends on amplifier/encoder used (serial, USB, Bluetooth, etc.)
Diagnostic Claims	None. "Does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data."
Method of Operation	Processes EEG information, separates it into user-specified frequency bands, and displays results as biofeedback.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. This document does not describe a clinical performance study using a test set of patient data, as it's a software for biofeedback, not diagnosis. The "test" in such a context would typically involve software verification and validation (V&V) against functional requirements, but this detail isn't in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. No ground truth establishment by experts is described for a test set, as no such study is presented.

4. Adjudication method for the test set

Not Applicable / Not Provided. No test set or adjudication process is described.

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

No. An MRMC study was not done. This device is not an AI-assisted diagnostic tool; it's a biofeedback display software.

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

Not Applicable / Not Provided. While the software operates "standalone" in the sense that it processes data and displays it, this refers to its direct functional performance in processing and displaying EEG data according to its specifications, not in making an independent diagnostic decision. The document doesn't detail specific standalone performance metrics in a study context.

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

Not Applicable / Not Provided. No ground truth for a diagnostic or classification task is used because the device expressly states it "does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data."

8. The sample size for the training set

Not Applicable / Not Provided. This device is not described as an AI/ML model that would require a training set. It is a deterministic software that processes and displays EEG data using established signal processing techniques (separating into frequency bands).

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

Not Applicable / Not Provided. As noted above, there is no mention of a training set or ground truth establishment for such a set.

Summary

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EEGer4

K122879

510(k) Summary

EEG Software.wwwwwwwwwwww

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in . accordance with requirements of 21 CFR §807.92.

Submitter:

EEG Software LLC 17625 Mayall Street Northridge, CA 91325 (818)-886-2585 Fax: (818) 886-1443

Contact Person:

Howard P. Lightstone

Summary preparation date: 30 January 2013

30 January 2013

Trade name: EEGer4

EEG biofeedback device Common name:

Classification name: Biofeedback device (HCC, 21 CFR §882-5050)

Predicate devices:

Device	510(k)	Product code	Manufacturer
Brainmaster2E	K990538	HCC	BrainMaster Technologies, Inc ,Bedford, OH
NeuroAmp	K073557	HCC	Corsoience GmbH & Co. KG, Germany
ProComp	K903497	HCC	Thought Technology LTD., Montreal,Quebec

Device Description:

The device processes EEG information, separates it into user-specified frequency bands, and

EEGer4 1 EEG Software LLC ~ 17625 Mayall Street ~ Northridge, CA 91325 www.eegsoftware.com (818) 886-2585 ph ~ (818) 886-1443 fax

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EEGer4

displays the results as biofeedback indications to a user.

Intended Use Statement

This device is to be used for general relaxation training when used with supported amplifier/encoders.

The Operator Manual contains the following text:

Indications for Use

This device is to be used for general relaxation training when used with supported amplifier/encoders.

General Warnings

· US Federal Law restricts this device to sale by or on the order of health care practitioners.

• Operators of this device are expected to be health care practitioners trained in neurofeedback or technicians trained in neurofeedback supervised by health care practitioners.

The top level screen of the EEGer4 software contains the following message in the lower right corner:

Caution: Federal law restricts this device to sale by or on the order of a health care practitioner.

Intended use: General relaxation

Parameter	EEGer4	Brainmaster 2EK990538	NeuroAmpK073557	ProCompK903497
Software	EEGer4	BMT	Cygnet (proprietaryversion of BioEra)	Biograph
Intendeduse	General relaxation whenused with supportedamplifier/encoders.	Relaxation Training	Biofeedback andRelaxation	Biofeedback andRelaxation
Supporteddevices	Mfr: BrainmasterBrainmaster 2EAtlantis versionsMfr: Thought TechnologyProComp versionsInfiniti versionsFlexcompMfr: J&J EngineeringC2 versionsC2+ versions	Brainmaster only	NeuroAmp only	ProComp orInfiniti devicesonly

Comparison to predicate devices:

EEGer4

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EEGer4

K122879

510(k) Summary

Parameter	EEGer4	Brainmaster 2EK990538	NeuroAmpK073557	ProCompK903497
	Mfr: TelediagnosticsA200 versionsA400 versions
OperatingSystem	Microsoft Windows (XP and later)
Computer	Generic PC computer supported by Microsoft Windows
SamplingRate	256 Hz	120-256 Hz	240/250 Hz	64-512 Hz
Number ofEEGchannels	4	2	2	4
Bandwidth	0 - 50 Hz	0.8 - 40 Hz	0.08-70 Hz	2-1000 Hz
PowerSupply	Not Applicable(software only)	Rechargeablebatteries	Via USB port	AA batteries,single use orrechargeable
Filtering	Digital Filters
DeviceInterface	Depends onamplifier/encoder used(serial, USB, Bluetooth,etc.)	Serial port	USB	USB or serial port

Conclusion:

The EEGer4 software is substantially equivalent to the software component of the predicate devices, indeed using some of the same hardware components. All devices use EEG signals, measure EEG, and process it to produce frequency band energy indications for feedback. Differences between the predicates and EEGer4 are in the area of user interfaces and the ability to use multiple devices (one at a time). EEGer4 does not incorporate any changes in intended use, method of operation, material or design that could affect safety or effectiveness. .

This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any trade secret or confidential information. This summary does not contain any patient identification information.

EEGer4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circular logo.

February 6,2013

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

EEG Software LLC c/o Mr. Howard Lightstone 17625 Mayall Street Northridge, California 91325

Re: K122879

Trade/Device Name: EEGer4 Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: HCC Dated: January 15, 2013 Received: January 23, 2013

Dear Mr. Lightstone:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Howard Lightstone

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/Medica]Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Joyce M. Whang

for Victor Krauthamer, Ph.D. Acting 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

EEGer4

Indications for Use

510(k) Number (if known): _K122879

Device Name: ____EEGer4 Neurofeedback Software

Indications for Use:

This device is to be used for general relaxation training when used with supported amplifier/encoders.

Prescription Use X (Part 21 CFR 801 Subpart D)

Joyce M. Whang

Division of Newological and Physical Medicine Devices 510(k) Number: K122879

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.