The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of call muscles to prevent venous thrombosis
Maintaining or increasing range of motion

Device Description

The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Neotonus MS-101 Magnetic Muscle Stimulator System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Physiological Effect Comparison to Predicate:
Evokes comparable skeletal muscle responses	Skeletal muscle responses evoked by the MS-101 were comparable to those evoked using the RICH-MAR electrical stimulator.
Evokes classic sigmoidal relationships between stimulus amplitude and muscle torque	Both types of stimulation (MS-101 and predicate) evoked the classic sigmoidal relationships.
Evokes classic sigmoidal relationships between stimulus frequency and muscle torque	Both types of stimulation (MS-101 and predicate) evoked the classic sigmoidal relationships.
Evokes classic muscle fatigue and increased one-half relaxation time with repeat contractions	Both types of stimulation (MS-101 and predicate) evoked the classic muscle fatigue and increased one-half relaxation time with repeat contractions.
Substantial Equivalence:
Deemed substantially equivalent to predicate electrical muscle stimulators for muscle rehabilitation.	The study concluded that the MS-101 is substantially equivalent to electromyostimulation for muscle rehabilitation based on the physiological comparisons.

Explanation of Implicit Criteria: The 510(k) summary doesn't explicitly list "acceptance criteria" in the way one might see for a diagnostic device (e.g., specific sensitivity/specificity targets). Instead, the established "acceptance criteria" are implied by the nature of a substantial equivalence claim: that the new device (MS-101) performs in a physiologically comparable manner to a legally marketed predicate device (RICH-MAR Theratouch electrical muscle stimulator) for its intended use. The study directly addresses this by demonstrating similar physiological responses.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Nine healthy volunteers.
Data Provenance: The document does not specify the country of origin of the data. It was a prospective study, as it involved stimulating volunteers and observing their responses.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable in the context of this study. This study was a physiological comparison, not one that relied on expert interpretation for ground truth. The "ground truth" was the observed physiological responses (muscle torque, fatigue, etc.) themselves, measured directly from the volunteers.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The study involved direct physiological measurements and comparisons, not subjective interpretations requiring adjudication.

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 done.
Effect Size: N/A, as this type of study was not conducted. This device is a therapeutic stimulator, not an AI-based diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the traditional sense of an algorithm. The MS-101 is a physical medical device. The study evaluated the device's physiological effects directly, without a human-in-the-loop scenario as might be seen with an AI diagnostic. The closest analogy would be that the "standalone" performance was the direct measurement of its effect on muscle responses in volunteers.

7. The Type of Ground Truth Used

Type of Ground Truth: Physiological measurements and observations. These included:
- Skeletal muscle responses.
- Relationships between stimulus amplitude and muscle torque.
- Relationships between stimulus frequency and muscle torque.
- Muscle fatigue and one-half relaxation time with repeat contractions.
  The "ground truth" was established by directly measuring these effects in the human subjects.

8. The Sample Size for the Training Set

Sample Size for Training Set: Research studies for 510(k) submissions of this nature typically don't involve a separate "training set" for an algorithm. This study was a direct comparison of physiological effects. If any preliminary work or predicate device data informed the design or parameters of the MS-101, it's not detailed here, but it wouldn't be referred to as a "training set" in the context of an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable as there was no explicit "training set" or AI/ML algorithm involved.

Summary

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

510(k) Summary

Neotonus, Inc. MS-101 Magnetic Muscle Stimulator System

K973929

Sponsor 1.
Neotonus, Inc. 810-A Franklin Court Marietta, GA 30067

Tony J. Morris Contact Person: President

May 21, 1998 Date Prepared:

Devicc Name 2.

Classification Name: Powered Muscle Stimulator, 21 CFR 890.5850, Product Code 89IPF, Class II MS-101 Magnetic Muscle Stimulator System Proprietary Name:

Intended Use 3.

The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Neotonus MS-101 is indicated for use in stimulating neuromuscular tissues for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Use for Muscle Stimulators:

Relaxation of muscle spasms 8
Prevention or retardation of disuse atrophy 4
Increasing local blood circulation .
Muscle re-education .
Immediate post-surgical stimulation of call muscles to prevent venous . thrombosis
Maintaining or increasing range of motion .

4. Device Description

The MS-101 Magnetic Muscle Stimulator System consists of a stimulator Control Unit and a Treatment Wand. The Control Unit is used to generate a voltage signal that

and the comments of the management one offer and the county of the market of the many

.. ...

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

periodically charges a "C" shaped magnetic coil which is held against the patient's skin nearest the muscle group to be stimulated. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-duty "Rest" period (0-60 sec).

Basis For Substantial Equivalence ર્ડ

The MS-101 is substantially equivalent to electrical stimulators used for muscle renabilitation and the indications as stated above. In particular, the MS-101 is substantially equivalent to the RICII-MAR Theratouch electrical muscle stimulator. A clinical study was conducted to compare the physiological effect of the MS-101 to that of the RICH-MAR electrical stimulator. The knee extensor muscles of nine healthy volunteers with varying degrees of muscle tone were stimulated using both the MS-101 and the electrical muscle stimulator. The study showed that:

. The skelctal muscle responses evoked by the MS-101 were comparable to those evoked using the RICH-MAR electrical stimulator.
. Both types of stimulation evoked the classic sigmoidal relationships between stimulus amplitude and muscle torque and between stimulus frequency and muscle torque.
Both types of stimulation evoked the classic muscle fatigue and increased one-. half relaxation time with repeat contractions.
The MS-101 is substantially equivalent to electromyostimulation for muscle rehabilitation.

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

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 1998

Mr. James R. Veale Vice President, Regulatory Services Medical Device Consultants, Inc. Representing Neotonus, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K973929 Neotonus MS-101 Magnetic Muscle Stimulator System Regulatory Class: II Product Code: IPF Dated: February 18, 1998 Received: February 20, 1998

Dear Mr. Veale:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Frid and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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

Page 2 - Mr. James R. Veale

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 requlation (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" (21 CFR 807.97). Other gener 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,

Jacotte

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

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

510(k) Number (it known): K973929

Device Name: NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM

Indications For Use:

The Neotonus MS-101 Magnetic Muscle Stimulator System is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

The Neotonus MS-101 is indicated for use in sumulating neuromuscular tiasucs for bulk muscle excitation in the legs or arms for rehabilitative purposes.

Indications for Usc for Muscle Stimulators:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy t
Increasing local blood circulation レ
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANCITITUR PAGE 16 NECESSARY

Concurrence of CDRH, Office of Donco Evaluation (ODE)

Prescription Use (Fer 21 CFR 801.109

Over-the-Counter Use

(Optional Format 1-2-96)

Robert J. De Luca

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).