The WL-2206A1 and WL-2206A2 are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

AI/ML Overview

The provided text is a 510(k) summary for an interferential stimulator device, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific metrics (like MRMC studies or standalone performance) is not applicable or available in this document.

The document focuses on demonstrating substantial equivalence to a predicate device (WL-2206A, K050847) by proving that engineering differences do not affect intended use or alter fundamental scientific technology.

Here's a breakdown of what is available based on the provided text, and why the requested information isn't present:

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

Not Applicable in this context. This device is an interferential stimulator, not an AI/ML diagnostic tool. The "performance" assessment focuses on showing that the new models (WL-2206A1 and WL-2206A2) maintain the same safety and effectiveness as the predicate device (WL-2206A).
Reported "performance" (as described): "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
Acceptance Criteria Mentioned (for substantial equivalence):
- Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
- Software verification according to FDA software guidance.
- Engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device compared to the predicate.

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. Clinical test sets with patient data are not described for this type of device submission. The verification and validation tests are likely engineering and electrical performance tests, not clinical studies in the AI/ML sense.

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. "Ground truth" in the AI/ML sense (e.g., expert consensus on clinical findings) is not relevant for this physical stimulator device. The "ground truth" for its safety and effectiveness is tied to engineering standards and a comparison to a legally marketed predicate.

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

Not Applicable. No clinical test set requiring adjudication of findings is described.

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 not an AI/ML device, so no MRMC study would be conducted.

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 (expert consensus, pathology, outcomes data, etc.)

Not Applicable. As mentioned, "ground truth" in the AI/ML context is not relevant here. The "truth" for this device revolves around meeting established electrical, safety, and performance standards as set against a predicate device.

8. The sample size for the training set

Not Applicable. This device does not use a "training set" in the machine learning sense.

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

Not Applicable. No training set exists for this device.

In summary: The provided 510(k) summary is for an electro-medical stimulator device (IF series True sine interferential stimulator / Model: WL-2206A1 & WL-2206A2), not an AI/ML-driven device. As such, the study design and criteria requested are based on AI/ML device approval processes and are fundamentally different from what is described in this document. The submission focuses on demonstrating substantial equivalence to a predicate device through engineering verification and validation, and compliance with general safety standards.

Summary

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MAY 10 1005

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:

1. Submitter's Identifications: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
  Contact: Mr. Mike Price

Date of Summary Preparation: March 2006.

2. Name of the Device:

IF series True sine interferential stimulator / Model: WL-2206A1 & WL-2206A2.

3. Information of the 510(k) Cleared Device (Predicate Device):

WL-2206A (K050847) .

4. Device Description:

5. Intended Use:

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

In addition, the standard for the statement of indications and contraindication for use are provided hereafter.

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6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as a follows:

Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

1. Conclusions

The true sine interferential stimulator, model WL-2206A1 & WL-2206A2, has the same intended use and technological characteristics as the cleared device of WL-2206A (K050847). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 10 2006

Theratech, Inc. c/o Mr. Michael Price 1109 Myatt Blvd. Madison, Tennessee 37115

Re: K060975

Trade/Device Name: IF True Sine Interferential Stimulator Models WL-2206A1 and WL-2206A2 Regulatory Class: Unclassified Product Code: LIH Dated: March 27, 2006 Received: April 10, 2006

Dear Mr. Price:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

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Page 2 - Mr. Michael Price

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Herbert Semmering

N
DE

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name: IF series True sine interferential stimulator / Model: WL-2206A1 and WL-2206A2.

Indications For Use:

...

... ..

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

Prescription Use V (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Iffice of Device Evaluation (ODE) Concurrence of CDRI

Helder Remers nd
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number_K060975

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).