The Muscle Stimulation System 110 is a portable, externally-powered device which provides electrical stimulation to the quadriceps using constant current pulses. Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into soft 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. An optional accessory to the system is the Niveus Medical StayCool FlexPaks.

AI/ML Overview

The provided text describes a 510(k) summary for the Niveus Medical Muscle Stimulation System 110. This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines minor modifications to the device.

However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

A table of acceptance criteria with reported device performance: The document states that software verification testing, simulated use testing, and real-time aging data were used, but it does not provide specific acceptance criteria or the results of these tests in a quantifiable manner.
Sample sizes and data provenance for test sets: There's no mention of the number of participants or data origin for any testing.
Number and qualifications of experts for ground truth: No expert involvement for establishing ground truth is described.
Adjudication method for the test set: No adjudication method is mentioned.
MRMC comparative effectiveness study: No such study is described. This device is a muscle stimulator, not an AI diagnostic tool, so this type of study would not be applicable.
Standalone algorithm performance: This is not an AI algorithm; it's a physical medical device.
Type of ground truth used: Not applicable in the context of this device's testing as described.
Sample size and ground truth for the training set: Not applicable as it's not an AI/ML device with a training set.

Based on the information provided in the document, here's what can be extracted and inferred:

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

Acceptance Criteria Category (Inferred)	Reported Device Performance (as stated in document)
User Interface Functionality	Evaluated through software verification testing
Stimulation Array Pad Integrity	Evaluated through simulated use testing
Shelf-Life	Supported by real-time aging data
Overall Safety & Effectiveness	Bench performance data confirmed the device is as safe and effective and substantially equivalent to the predicate device

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

Sample Sizes: Not provided.
Data Provenance: Not specified. The testing seems to be internal bench and simulated use testing, rather than human subject trials.

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

Not applicable/Not mentioned. The testing described (software verification, simulated use, real-time aging) does not involve establishing ground truth typically associated with expert review of data (e.g., in diagnostic imaging studies).

4. Adjudication method for the test set:

Not applicable/Not mentioned.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a muscle stimulation system, not an AI/ML diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

Not applicable in the conventional sense. The "ground truth" for the performance data would be the established functional requirements for the software, the physical integrity and performance requirements for the array pads, and the stability parameters for the shelf-life testing. These are determined by engineering specifications and standards, not expert consensus or pathology in the context of diagnostic performance.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that requires a training set.

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

Not applicable. This device does not use machine learning or AI that requires a training set.

Summary of the Study:

The document describes a submission for demonstrating substantial equivalence (510(k)) for the Niveus Medical Muscle Stimulation System 110. The study referenced consists of bench performance data to support minor modifications to a previously cleared predicate device. These modifications include:

Updates to the user interface: Evaluated through software verification testing.
Minor changes for improved mounting of the touchscreen: Not explicitly stated how this was evaluated, but likely part of general design and manufacturing verification.
A change to the Stimulation Array Pads affecting a non-functional portion: Evaluated through simulated use testing.
Extension of the expiration date to 18 months: Supported by real-time aging data.
Addition of an instructional label to the Interconnect Cable connector: This is a labeling change, not a performance study.

The overall conclusion is that these bench performance data confirm the subject device is as safe and effective and substantially equivalent to the predicate device. Specific quantitative acceptance criteria or detailed results of these tests (e.g., number of test cases for software verification, specific parameters for simulated use, stability data points for aging) are not provided in this summary.

Summary

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

July 23, 2015

Niveus Medical. Inc. c/o Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA, 94010

Re: K150742

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: June 19, 2015 Received: June 26, 2015

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, 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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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 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/Resourcesfor You/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.

Sincerely yours,

Carlos L. Pena -50/Δ

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) K150742

Device Name Muscle Stimulation System 110

Indications for Use (Describe) The Niveus Medical Muscle Stimulation System 110 is indicated for:

1. Maintaining or increasing range of motion of the knee joint
1. Prevention or retardation of disuse atrophy in the quadriceps

Muscle re-education of the quadriceps

1. Relaxation of muscle spasms

Increasing local blood circulation

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summarv

I. SUBMITTER

510(k) Owner: Niveus Medical, Inc. 849 Independence Avenue Suite C Mountain View, CA 94043 650-336-7922 (phone)

Contact Person: Cindy Domecus, R.A.C. (US &EU) Principal, Domecus Consulting Services LLC (650) 343-4813 (phone) (650) 343-7822 (fax)

Date Prepared: July 23, 2015

II. DEVICE

Name of Device:	Muscle Stimulation System 110
Common or Usual Name:	Powered Muscle Stimulator
Classification Name:	Powered Muscle Stimulator (21 CFR 890.5850)
Regulatory Class:	II
Product Code:	IPF

III. PREDICATE DEVICE

The predicate device is the Niveus Medical Muscle Stimulation System 110 cleared under K123642.

The predicate device has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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Special 510(k) Niveus Medical, Inc.

Arrav Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.

V. INDICATIONS FOR USE

The Niveus Medical Muscle Stimulation System 110 is indicated for:

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

The indications for use are unchanged from the predicate.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The subject device represents minor modifications to the predicate device, as follows:

Update user interface to reflect user preferences
Minor changes to allow for improved mounting of touchscreen ●
A non-functional portion of the bandage material near the Stimulation Array ● Pad's center is separated from rest of pad such that it remains on release liner during application, leaving a region of uncovered skin in treatment region
Extend expiration date to 18 months
An instructional label has been added to the Interconnect Cable connector as an indicator for the top side of the connector

PERFORMANCE DATA VII.

The modification to the user interface was evaluated through software verification testing. The change to the Stimulation Array Pads was evaluated through simulated use testing. The shelf-life extension was supported by real-time aging data.

VIII. CONCLUSION

The bench performance data provided in support of the 510(k) confirm that the subject device is as safe and effective and substantially equivalent to the predicate device.

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).