The BrainMaster™ 2E is indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation.

Device Description

This two-channel digital Biofeedback/EEG device uses industry-accepted standard Windows - based PC as control and display console. The device consists of the following:

a) BrainMaster™ 2E Hardware Module
BrainMaster™ BMT (basic educational/research SW) b)
BrainMaster™ PT (clinical SW) c)
The System uses commercially available standard EEG electrodes and pastes such as 9 mm gold disks with 10 - 20 paste.

AI/ML Overview

This 510(k) summary for the BrainMaster™ 2E device indicates that clinical studies were not performed to establish substantial equivalence. Instead, the submission relies on non-clinical tests (electrical, mechanical, and environmental) and comparison to predicate devices, asserting that differences do not affect functionality or safety/effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable based on the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with corresponding device performance metrics in relation to clinical efficacy for relaxation training. Instead, the acceptance criteria are implicitly tied to meeting regulatory standards for electrical, mechanical, and environmental safety, as demonstrated by non-clinical testing, and maintaining substantial equivalence to predicate devices in terms of technical specifications.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Electrical Safety	Compliance with IEC 60601-1 (electrical isolation) and FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND.	"BrainMaster™ 2E tested product met all relevant requirements of the aforementioned test." "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards."
Mechanical Performance	Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND.	"None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards." (Implied to cover mechanical aspects alongside electrical)
Environmental Performance	Compliance with FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND.	"None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards." (Implied to cover environmental aspects)
ElectromagneticCompatibility	Compliance with DCRND Reviewer's Guideline, November 1993 for Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing.	"All testing met required parameters."
Functional Equivalence	Substantial equivalence in intended use, method of operation, material, and design to predicate devices (Lexicor NRS-2D / Stoelting AT 62 EEG).	"The BrainMaster™ 2E device is substantially equivalent in intended use, design, material and technology as the Lexicor NRS-2D/Stoelting AT 62 EEG devices. All devices use EEG Signals, measure EEG and process it to produce frequency band energy. Differences do not affect functionality of the device..."

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

Clinical tests were "Not Applicable." Therefore, there was no test set of patient data used to directly evaluate the device's performance in achieving relaxation via alpha EEG biofeedback. The testing focused on device safety and technical specifications, not clinical outcomes.

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

Not applicable, as no clinical test set was used and no clinical ground truth was established for the device's primary intended use. The "ground truth" implicitly referred to here is compliance with technical standards as assessed by a contract testing laboratory.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. This device is an EEG biofeedback system, not an AI-assisted diagnostic imaging tool that would involve human readers.

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

This refers to the device's technical specifications and electrical/mechanical performance. The device's performance in these non-clinical aspects was tested in a standalone manner by a contract laboratory. The "performance" in this context refers to its ability to meet electrical isolation, EMI/EMC, and basic functional specifications, which it reportedly did.

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

For the non-clinical testing, the "ground truth" was compliance with established industry standards (e.g., IEC 60601-1) and FDA guidance documents for medical device safety and performance. This is a technical standard ground truth, not a clinical one based on patient data or expert consensus on clinical outcomes.

8. The sample size for the training set

Not applicable. The device relies on fundamental EEG principles and digital signal processing, not a machine learning model that requires a training set of data.

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

Not applicable, as there was no training set for a machine learning model.

Summary

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K990538

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Submitter's Identification: 1.

BrainMaster 6588 Woodhawk Drive Cleveland, Ohio 44124

Date Summary Prepared: Contact: Thomas F. Collura, Ph.D. October 1998

2. Name of the Device:

The BrainMaster™ 2E

3. Predicate Device Information:

The Lexicor NRS-2D, Lexicor Medical Technology, Inc., Boulder, 1. Colorado, K#961645.
1. Stoelting AT 62 EEG, Stoelting Company, K#965006.

4. Device Description:

Executive Summary and Device Description:

This two-channel digital Biofeedback/EEG device uses industry-accepted standard Windows - based PC as control and display console. The device consists of the following:

a) BrainMaster™ 2E Hardware Module
BrainMaster™ BMT (basic educational/research SW) b)
BrainMaster™ PT (clinical SW) c)

The System uses commercially available standard EEG electrodes and pastes such as 9 mm gold disks with 10 - 20 paste.

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ડ. Intended Use:

Comparison to Predicate Devices: 6.

Table of Comparison to Legally Marketed Devices: શે.

The following is a Comparison Chart outlining differences and similarities between the BrainMaster™ 2E device and the Lexicor NRS-2D/Stoelting AT 62 EEG devices:

Device Parameters	BrainMaster™ Type 2EDevice	NRS-2D Device	Stoelting AutogeniceAT62
Software	BMT	BioLex	AT62
Interface	Serial Port	Parallel Port	none - standalone
Channels	1 or 2	1 or 2	one
Sampling Rate	120 / second	128 / second	N/A
Notch Filtering	40 Hz cutoff	50 or 60 Hz	none
Common ModeRejection	>100 dB	>90 dB	120dB
Gain	20,000	8000	50,000
Sampling	8 bit	12 bit	N/A
Input Impedance	10 M ohms	>1 G ohm	200 K ohms
Operating System	Windows	MS-DOS	built-in
Frequency Analysis	Digital Filtering	FFT	Analog Filtering
Power	rechargeable batteries	medical gradepower supply	rechargeable batteries

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Section 7 - Electrical, Mechanical and Environmental Testing

Testing information demonstrating safety and effectiveness of The BrainMaster™ Type 2E in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

Testing was conducted by a contract testing laboratory on the BrainMaster™ 2E device per IEC 60601-1 (electrical isolation).

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.

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It was a contract testing laboratory conclusion that BrainMaster™ 2E tested product met all relevant requirements of the aforementioned test.

In addition, the following testing was conducted by a contract testing laboratory:

Radiated and Conducted Electromagnetic Energy and Magnetic Field Testing on the BrainMaster™ 2E. Testing was conducted per the DCRND Reviewer's Guideline, November 1993. All testing met required parameters.

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

The BrainMaster™ 2E device is substantially equivalent in intended use, design, material and technology as the Lexicor NRS-2D/Stoelting AT 62 EEG devices. All devices use EEG Signals, measure EEG and process it to produce frequency band energy. Differences do not affect functionality of the device thus, when compared to the predicate device, The BrainMaster™ 2E does not incorporate any changes in intended use, method of operation, material or design that could affect safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them, resembling a stylized caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 19 1999

BrainMaster c/o Ms. Susan D. Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K990538 Trade Name: The BrainMaster 2E Regulatory Class: II Product Code: HCC and GWQ Dated: February 17, 1999 Received: February 19, 1999

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -- Ms. Susan D. Goldstein-Falk

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Sage

In Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT B

Page _ 1 __ of __ 1 __

510(k) NUMBER (IF KNOWN): K990538

DEVICE NAME: The BrainMaster™ 2E

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K950335

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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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.