The Muscle Stimulation System 110 is a portable, externallypowered device which provides electrical stimulation to the quadriceps using constant current pulses. The device is a Powered Muscle Stimulator per 21 CFR § 890.5850 (Product Code: IPF). Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into disposable Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.
The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and instructions for use.

AI/ML Overview

The provided text is a 510(k) summary for the Niveus Medical Muscle Stimulation System 110, which is a Powered Muscle Stimulator. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed clinical study with specific acceptance criteria and performance metrics.

Therefore, the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, and specific study types like MRMC or standalone performance, are not explicitly present in this 510(k) summary.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" in the sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding "reported device performance" are provided for the Muscle Stimulation System 110. The 510(k) relies on demonstrating substantial equivalence to predicate devices through various types of testing and comparisons.

Acceptance Criteria Category	Reported Device Performance (Summary)
Technological Characteristics	Substantially equivalent to predicate devices for: output waveforms, basic unit characteristics, output specifications, accessories, and software/firmware/microprocessor control, as per FDA's June 1999 guidance for powered muscle stimulators.
Usability	Device performs as intended.
Electrical Safety and Compatibility	Device performs as intended. Conforms to UL and IEC electrical safety and performance standards.
Software and Hardware Validations	Device performs as intended.
Packaging and Transit Validation	Device performs as intended.
Shelf-life and Biocompatibility Evaluations	Device performs as intended.

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

Sample Size for Test Set: Not specified. The document mentions "usability testing," but does not provide details on the number of participants or cases in this testing.
Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided as the submission focuses on engineering and regulatory compliance testing rather than clinical expert-driven ground truth establishment.

4. Adjudication method for the test set:

This information is not provided.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a muscle stimulator, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

Standalone Performance: No, a standalone algorithm performance study is not applicable as this is a physical medical device (muscle stimulator), not a diagnostic algorithm. Performance is assessed through engineering validations and safety tests.

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

The concept of "ground truth" (as understood in the context of diagnostic performance) is not applicable to this submission. The "ground truth" for the device's functionality is its ability to perform its intended electrical stimulation safely and effectively based on engineering specifications and compliance with standards.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This device is a hardware system, not a machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable.

Summary of the Study:

The study presented in the 510(k) summary for the Niveus Medical Muscle Stimulation System 110 is primarily a regulatory submission aimed at demonstrating substantial equivalence to previously cleared predicate devices. It is not a clinical efficacy or diagnostic performance study in the traditional sense.

The "study" involved various forms of engineering and compliance testing to show that the device performs as intended and is as safe and effective as the predicate devices. These tests included:

Usability testing: To ensure the device can be used effectively and safely.
Electrical safety and compatibility testing: To ensure the device meets safety standards (UL and IEC).
Software and hardware validations: To confirm proper functionality of the device's components.
Packaging and transit validation: To ensure the device remains functional after shipping.
Shelf-life and biocompatibility evaluations: To address material safety and device longevity.

The conclusion is based on these testing data, asserting that the device is "safe and effective and functions in substantially equivalent manner to the predicate devices." The general controls provisions of the Act, Good Manufacturing Practices, Quality System Regulations, and risk management were applied throughout the design and manufacturing process.

Summary

{0}------------------------------------------------

K123642

Niveus Medical, Inc.

Muscle Stimulation System 110

510(k) Summary

MAR 2 9 2013

510(k) Owner Niveus Medical, Inc. 2490 Hospital Drive, Suite 310 Mountain View, CA 94040 Brian Fahey, Ph.D. Telephone: (650) 230-0226 Fax: (650) 962-4561 Email: brian@niveusmedical.com

Contact Cindy Domecus, R.A.C. (US & EU) (650) 343-4813 domecusconsulting@comcast.net

November 21, 2012 Date Prepared

Device Name Trade Name: Muscle Stimulation System 110 Powered Muscle Stimulator Classification Name: Powered Muscle Stimulator 21 CFR 890.5850 (Product Code IPF)

Predicate Devices

Bio-Medical Research, Ltd.'s Neurotech Kneehab XP, Type 411 (K083105) Koalaty Products, Inc.'s Twin Stim TENS/EMS Unit (K080661) CEC Electronica SRL's Combi 8 Max (K070888)

Device Description

The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and instructions for use.

Indications for Use

The Muscle Stimulation System 110 is indicated for:

Maintaining or increasing range of motion of the

{1}------------------------------------------------

Niveus Medical, Inc.

knee joint

Prevention or retardation of disuse atrophy in the . quadriceps
Muscle re-education of the quadriceps .
Relaxation of muscle spasms .
Increasing local blood circulation .

Technological Characteristics

The technological characteristics of the subject device are substantially equivalent to the predicate devices and have been compared to the predicates for the following characteristics listed in FDA's June 1999 guidance for powered muscle stimulators: output waveforms, basic unit characteristics, output specifications, accessories, and software/firmware/microprocessor control.

Performance Data

Performance data from usability testing, electrical safety and compatibility testing, software and hardware validations, packaging and transit validation, and shelf-life and biocompatibility evaluations demonstrate that the device performs as intended and is substantially equivalent to the predicate devices.

Conclusion

Based on the testing data provided, the Muscle Stimulation System 110 is as safe and effective and functions in substantially equivalent manner to the predicate devices identified above. To minimize potential hazards to the patient, the device has been specified, manufactured, and the design verified based on Good Manufacturing Practices and the Quality System Regulations, with risk management applied throughout the process. The system conforms to UL and IEC electrical safety and performance standards.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the caduceus symbol. The text is in all capital letters.

March 29,2013

Public Health Service

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

Niveus Medical, INC. % Ms. Cindy Domecus 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K123642

Trade/Device Name: Muscle Stimulation System 110 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: February 11, 2013 Received: February 14, 2013

Dear Ms. Domecus:

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. Iisting 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 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.

{3}------------------------------------------------

Page 2 - Sharyn Orton, Ph.D.

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/CDRHOffices/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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K123642

Device Name: Muscle Stimulation System 110

Indications for Use:

The Niveus Medical Muscle Stimulation System 110 is indicated for:

Maintaining or increasing range of motion of the knee joint .
Prevention or retardation of disuse atrophy in the quadriceps .
Muscle re-education of the quadriceps .
Relaxation of muscle spasms .
Increasing local blood circulation .

Prescription Use _________________X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Victor Krautha 2013.03.29 17

Division of Neurological and Physical Medicine Devices 510(k) Number: K123642

1-2

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).