The MEDSTAR 100 Interferential Stimulator should only be used under the 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.

Device Description

The MEDSTAR 100 is a DC battery powered device that generates small pulses of electric current. These small pulses of electrical current are delivered through leads cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study to prove the device meets such criteria in the context of clinical or diagnostic efficacy. Instead, the document is a 510(k) summary and FDA clearance letter for a medical device called the MEDSTAR 100 Interferential Stimulator.

The "study" mentioned relates to functional and safety testing to demonstrate substantial equivalence to a predicate device, not clinical performance or diagnostic accuracy.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not provide a table of acceptance criteria for clinical performance or diagnostic accuracy. It states:

Functional & Safety Testing: "Was performed with a signal generator voltmeter, 420 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V1 was set at approximately 2 volts. The voltage drop across the electrodes (V7) was measured and the impedance of the electrodes calculation is as follows: Impedance (Z) = V7/V1 x R"
Reported Performance: No specific numerical performance results from this testing are reported in the provided text. The document only describes the methodology.
Conclusion regarding performance: "The MEDSTAR™ 100 Interferential Stimulator is substantially equivalent to the HMP 4000 Interferential Stimulator for intended use, design, and electrical performance." This is an overall conclusion based on the testing, but no specific performance values are listed against explicit acceptance criteria beyond the general statement of electrical performance equivalence.

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

Sample size for test set: Not applicable in the context of a clinical or diagnostic test set. The functional and safety testing described would typically involve a small number of devices, often a single unit or a few units, to confirm manufacturing specifications and basic electrical safety. The text does not specify the number of devices tested.
Data provenance: Not applicable. The testing is described as "performed" by the submitter, MedNet Services, Inc. It is functional and safety testing, not human subject data.

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

Not applicable. The "ground truth" here is the expected electrical behavior of the device and its safety, which is assessed through engineering measurements against established standards or predicate device specifications, not by expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. There is no "adjudication" in the clinical sense mentioned. The functional and safety testing relies on direct electrical measurements.

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. This is not an AI device or a diagnostic device that would involve human readers interpreting cases. It is an Interferential Stimulator for pain relief.

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

No. This is not an algorithm-based device. It's a physical medical device.

7. The type of ground truth used

For the functional and safety testing, the "ground truth" would be the engineering specifications and established electrical safety standards for medical devices of this type, potentially derived from the predicate device's characteristics. There's no clinical ground truth (pathology, expert consensus, outcomes data) as this is not a diagnostic device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. As above, no training set.

Summary

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NOV 1 6 2001

SUMMARY AND CERTIFICATION Section 2.

The MEDSTAR 100 Interferential Stimulator is a Class II device. The 510(k) Summary is provided in Subsection A on the following page, in accordance with 21 CFR Part 807.

Because this is not a Class III device, nor is it substantially equivalent to a Class III device, the Literature Search and Certification requirement by the Safe Medical Devices Amendments (SMDA) is not applicable.

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:

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™ 100 Interferential Stimulator
COMMON NAME:	Interferential Stimulator (LIH)
CLASSIFICATION:	Class II
PRODUCT CODE:	LIH
PREDICATE DEVICE (S):	HMP 4000 Interferential Stimulator (K924961)
DEVICE DESCRIPTION:	The MEDSTAR 100 is a DC battery powered devicethat generates small pulses of electric current. Thesesmall pulses of electrical current are delivered throughleads cables to electrodes placed on the skin. Theseelectrical pulses pass through the skin and activateunderlying nerves.

10F2

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K013082
20F2

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:

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

FUNCTIONAL & SAFETY TESTING:

Was performed with a signal generator voltmeter, 420 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V1 was set at approximately 2 volts. The voltage drop across the electrodes (V7) was measured and the impedance of the electrodes calculation is as follows:

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

Refer to section 6 for further details.

CONCLUSION:

The MEDSTAR™ 100 Interferential Stimulator is substantially equivalent to the HMP 4000 Interferential Stimulator for intended use, design, and electrical performance.

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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 and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 1 6 2001

Re: K013082

Trade/Device Name: MEDSTAR 100 Interferential Stimulator Regulatory Class: Unclassified Product Code: LIH Dated: September 11, 2001 Received: September 14, 2001

Dear Mr. Mathews:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be 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 conninered prior to May 20, 2017 3) in accordance with the provisions of the Federal Food, Drug, de riccs that have been roomsomed in avere approval of a premarket approval application (PMA). and Cosmetic Act (7107 that do not required to the general controls provisions of the Act. The 1 ou may, dicrorolo, manel and act include requirements for annual registration, listing of general oonly of the results, 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 chassinod (600 a00 royals. Existing major regulations affecting your device can thay be subject to sublications, 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 loast of advisou that I Dri over device complies with other requirements of the Act that I Dr Has intact a and regulations administered by other Federal agencies. You must or any I odetar bakated and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, laooiing (21 CFR Part 820); and if applicable, the electronic form in the quality of ovisions (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 anow you to begin manieting your and equivalence of your device to a legally premarket notification: "The PDA miding of backing of backed 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 II you desire specific advice for your avitro diagnostic devices), please contact the Office of additionally 21 CHC rate 007.10 for mirally, for questions on the promotion and advertising of Compliance at (301) 597 1059 - 128288 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). It guilation chittica, "Misoranang of esponsibilities under the Act may be obtained from the Other general information on your responsible 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 yours,

sincerely, yours,

Mark n Melkison

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 1 6 2001

K013082

Indications For Use Page

510(k) number: To be Assigned

Device Name: MEDSTAR 100 Interferential Stimulator

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milhisan

Division of General, Restorative and Neurological Devices

510(k) Number K013082

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).