The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:

symptomatic relief and management of chronic pain and/or .
an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.

When used for neuromuscular stimulation, the standard indications for use are:

Relaxation of muscle spasms .
Prevention or retardation of disuse atrophy .
Increasing local blood circulation ●
Muscle re-education ●
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; ● and
Maintaining or increasing rang of motion .

Device Description

The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.

AI/ML Overview

The provided text describes a 510(k) summary for the MEDSTAR™ 150 Powered Muscle Stimulator. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria, sample sizes, or ground truth methodologies common in AI/software device submissions.

Therefore, many of the requested categories (such as acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, and standalone performance) are not applicable or extractable from this specific document.

This document is from 2001 and concerns a hardware medical device (a powered muscle stimulator), not an AI/software device. The regulatory requirements and testing methodologies for hardware stimulators are vastly different from those for AI/ML-based diagnostic or therapeutic software, especially concerning clinical study design as you've outlined in your request.

Here's what can be extracted based on the provided text, with clarifications for the non-applicable sections:

Acceptance Criteria and Device Performance Study for MEDSTAR™ 150

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

Acceptance Criteria Category	Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance (Summary of functional testing)
Functional Safety	Not explicitly defined as pass/fail numerical thresholds in this document, but implied to meet general operational safety standards.	"Was performed with a signal generator voltmeter, 20 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V¡ was set at approximately 2 volts. The voltage drop across the electrodes (V2) was measured and the impedance of the electrodes calculation is as follows: Impedance (Z) = V7/V1 x R"
Substantial Equivalence	The device should be "substantially equivalent to 4000+ Interferential Powered Muscle Stimulator in intended use, design and performance."	The FDA granted 510(k) clearance, indicating that the device was determined to be substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document describes functional safety testing, which typically involves device-level electrical and performance measurements, not human subject testing with a "test set" in the context of clinical data. It's a hardware device, not an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth, in the context of expert consensus, is not relevant for this type of device and its functional safety testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication is not relevant for this type of device and its functional safety testing.

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 is a hardware muscle stimulator, not an AI-assisted diagnostic or therapeutic software. MRMC studies are not relevant here.

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

Not applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

Not applicable. For the functional safety testing described, the "ground truth" would be the expected electrical and physical properties/outputs of the device as measured by standard laboratory equipment. There is no biological or diagnostic "ground truth" in the sense of pathology or expert consensus.

8. The sample size for the training set

Not applicable / Not provided. This device is not an AI/ML model, so there is no concept of a "training set."

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

Not applicable. As there is no training set, this is not relevant.

Summary

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A. 510(k) Summary

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:	K013081
SUBMITTER:	MedNet Services, Inc.2855 Anthony Lane, Suite B-10St. Anthony, MN 55418Phone: 612-788-6228Fax: 612-788-6228
CONTACT PERSON:	David L. Mathews
TITLE:	President
DATE PREPARED:	September 11, 2001
TRADE NAME:	MEDSTAR™ 150
COMMON NAME:	Powered Muscle Stimulator (89IPF)
CLASSIFICATION:	21 CFR 890.5850, Powered MuscleStimulator Class II
PRODUCT CODE:	IPF, LIH
PREDICATE DEVICE (S):	4000+ Interferential Powered Muscle Stimulator,K950783

DEVICE DESCRIPTION:
The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.
INTENDED USE:
Interferential Stimulation is used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:108

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K013081
2 OF 2

. Symptomatic relief and management of chronic pain and/or
. an adjunctive treatment in the management of post surgical and posttraumatic acute pain.

When used for neuromuscular stimulation, the standard indications for use are:

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

FUNCTIONAL SAFETY TESTING:

Was performed with a signal generator voltmeter, 20 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V ¡ was set at approximately 2 volts. The voltage drop across the electrodes (V2) was measured and the impedance of the electrodes calculation is as follows:

Impedance (Z) = V7/V1 x R Where V2 and V; are the voltage meter readings.

Refer to section 6 for further details.

CONCLUSION:

The MEDSTAR 150 is substantially equivalent to 4000+ Interferential Powered Muscle Stimulator in intended use, design and performance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Mr. David L. Mathews President MedNet Services, Inc. 2855 Anthony Lane, Suite B-10 St. Anthony, Minnesota 55418

Re: K013081

Trade/Device Name: MEDSTAR™ 150 Interferential and Powered Muscle Stimulator Regulation Number: 890.5850 and unclassified Regulation Name: Powered muscle stimulator and Interferential current therapy Regulatory Class: II Product Code: IPF, LIH Dated: September 11, 23001 Received: September 14, 2001

Dear Mr. Mathews:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1970, in easondance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, diereleve, mains 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 (PMA), it If your device is elassinod (600 as controls. Existing major regulations affecting your device can may oe subject to such additions, 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 I lease of advisou that I Drivisantes over device complies with other requirements of the Act that I DI Has made a cond regulations administered by other Federal agencies. You must or any I odetar states and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607), adoning (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David L. Mathews

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your finding of substantial equivalence of your device to a legally premated predicated. " cresults 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 21 CFR Part 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 Part 807.97). regaration childred, which on your responsibilities under the Act may be obtained from the O wision 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark M Mullener

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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NOV 2 0 2001

K013081

Indications For Use Page

510(k) Number (if known): Not yet assigned.

Device Name: MEDSTAR 150

Indications For Use:

symptomatic relief and management of chronic pain and/or .
an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.

When used for neuromuscular stimulation, the standard indications for use are:

Relaxation of muscle spasms .
Prevention or retardation of disuse atrophy .
Increasing local blood circulation ●
Muscle re-education ●
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; ● and
Maintaining or increasing rang of motion .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Minh N Mulkerson

510(k) Nu: K013081

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).