The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.

Device Description

The BioRehab System consists of an EMG amplifier, computer and software. Under the care and guidance of a physician or therapist, the BioRehab System supports relaxation and muscle reeducation by the application of electromyography (EMG) biofeedback. The BioRehab System supports patient game playing under EMG control. The patient consciously controls the EMG signal level from the therapist's selected muscle groups.

AI/ML Overview

This document is a 510(k) premarket notification for the Nicolet Biomedical BioRehab System, a biofeedback device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study with defined performance metrics. Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove it is not typically found or required in a 510(k) submission like this one.

Here's why and what information can be extracted/inferred:

510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. It does not usually involve extensive clinical trials or performance studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) application would.
"Summary of Safety and Effectiveness" vs. "Performance Study": The document explicitly states "Summary of Safety and Effectiveness". This summarization points towards a comparison with predicate devices, not a de novo study with acceptance criteria.

Therefore, I cannot populate the table or answer most of your numbered questions directly from the provided text because this type of study was not performed or reported in this 510(k) submission.

However, I can extract information related to the device and its intended use:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as this is a 510(k) submission for substantial equivalence. The "acceptance criteria" here implicitly is that the device is as safe and effective as the predicate devices.
Reported Device Performance: The document states:
- "The BioRehab System applies EMG signal detection and amplification to support relaxation and muscle reeducation therapy."
- "The EMG signal output of the BioRehab system is qualitative not quantitative."
- "Under control of the therapist, an EMG signal threshold is set for the patient to support control of the computer cursor."
- "The control of the computer cursor supports patient game playing on the computer."
- Conclusion: "The characteristics of the BioRehab System are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

The following numbered items cannot be answered from the provided text for the reasons explained above:

Sample sizes used for the test set and the data provenance: Not applicable to a 510(k) predicated on substantial equivalence without specific performance studies described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 a biofeedback system, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is used "Under the care and guidance of a physician or therapist" and involves "patient game playing under EMG control," indicating a human-in-the-loop system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for substantial equivalence.
The sample size for the training set: Not applicable, as this is not a machine learning device or a study describing a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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SEP - 6 2001

Image /page/0/Picture/1 description: The image shows the logo for "Nicolet Biomedical". The word "Nicolet" is in a large, bold, sans-serif font, with a thick black line underneath it. Below the line, the word "BIOMEDICAL" is printed in a smaller, sans-serif font, with the letters spaced out.

K011823

Summary of Safety and Effectiveness

Company Name:	Nicolet Biomedical Incorporated5225 Verona RoadMadison, WI 53711
Contact:Phone:Fax:	Glen Hermanson, Manager of Standards and Compliance608 441-2065608 441-2007
Summary Date:	June 6, 2001
Trade Name:	BioRehab System
Common Name:	Biofeedback Device
Classification Name:	21 CFR 882.5050; Product Code: HCC
Predicate Device(s):

K960508 510(k) Number: The Prometheus Group Manufacture: Pathway II Perineometer, MR Series of Amplifiers Trade Name:

K935853 Product Code: HCC 510(k) Number: UniTech Research Inc. Manufacture: EMG Trainer Trade Name:

K854277 Product Code: HCC 510(k) Number: Therapeutic Alliance Inc. Manufacture: Trade Name: NeuroEducator

Description of Device 1.0

Nicolet Biomedical Inc

Image /page/0/Picture/11 description: The image shows the ISO 9001 logo. The logo is black and white and features the letters "ISO" stacked on top of the number "9001". There are some other words on the left and right side of the logo, but they are too blurry to read. The logo is a symbol of quality management system certification.

5225 Verona Road Bldg. 2 Madison, Wisconsin USA 53711-4495 Tel: 608/273-5000 Fax: 608/273-5067 Toll free: 1-800/356-0007

Summary of Safety and Effectiveness Page 1 of 2

122

A Teermo Electron Company

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Image /page/1/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in large, bold, sans-serif font. Below "Nicolet" is a thick black line. Under the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter.

2.0 Intended Use

3.0 Technological

The BioRehab System applies EMG signal detection and amplification to support relaxation and muscle reeducation therapy. The significant components of the BioRehab System are a battery powered patient interface amplifier, computer software. Commercially available surface EMG electrodes connect to the amplifier.

The EMG signal output of the BioRehab system is qualitative not quantitative. Under control of the therapist, an EMG signal threshold is set for the patient to support control of the computer cursor. The control of the computer cursor supports patient game playing on the computer.

4.0 Conclusions

The characteristics of the BioRehab System are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the human services provided by the department. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2001

Nicolet Biomedical, Inc. c/o Mr. Gary Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K011823

Trade/Device Name: BioRehab System Regulation Number: 882.5050 Regulation Name: Biofeedback Device Regulatory Class: II Product Code: HCC Dated: June 6, 2001 Received: June 11, 2001

Dear Mr. Syring:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have hove have determined the device is substantially equivalent (for the indications for use above and 10 hors assort as a 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 press to rid) = 3, if = 1, = 1, = 1, = 1, = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of all Production 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 ( frenting 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 requirements, 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 - Mr. Gary Syring

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 your 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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Susan Wall, us

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

Enclosure

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510(k) Number (if known): KO11823

Device Name: BioRehab System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Signature of Officer

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_KO 1/8 2

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.