The WiTouch" Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.

Device Description

The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.

AI/ML Overview

The provided 510(k) summary for the WiTouch™ Pro Transcutaneous Electrical Nerve Stimulator (TENS) device does not contain information about acceptance criteria or a dedicated study to prove that the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than performance metrics related to diagnostic accuracy or clinical outcomes of a new treatment modality.

Here's a breakdown of why many of your requested items cannot be fulfilled from this document:

Acceptance Criteria & Reported Performance: This document doesn't define quantitative performance acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score) for the device's efficacy in pain relief. Instead, it compares technical specifications (waveform, current density, power density, physical characteristics) to predicate devices to argue substantial equivalence.
Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type for Test Set: These are all concepts relevant to studies evaluating the diagnostic or therapeutic performance of a device or algorithm, often involving patient data and human expert review. This 510(k) does not describe such a study. The "study" here is essentially the comparison of technical specifications against FDA-recognized safety and electrical standards and existing predicate devices.
Training Set Sample Size & Ground Truth: These are concepts for AI/ML model development. The WiTouch™ Pro is a hardware TENS device, not an AI/ML diagnostic tool, so these concepts do not apply in this context.

Summary of Information Available from the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, it demonstrates inherent safety and equivalence through compliance with recognized standards and comparison of technical specifications to legally marketed predicate devices. The "reported device performance" is essentially that its electrical output and physical characteristics are within acceptable ranges and comparable to existing TENS devices.

Acceptance Criteria (Implied by Predicate Comparison & Standards)	Reported Device Performance (WiTouch™ Pro)
Maximum average power density of electrodes with gel-pads < 0.25 W/cm² to reduce thermal burn risk (consistent with predicates).	0.00069 W/cm² @ 500 Ω (using smallest electrode conductive surface area) - Meets criterion.
Waveform: Pulsed biphasic (consistent with predicates).	Pulsed biphasic - Meets criterion.
Shape: Square (consistent with predicates).	Square - Meets criterion.
Phase Duration (Step-1 and Step-3): Comparable to predicates (e.g., 0 to 400µs at 50% peak amplitude, 0 to 300µs for predicates).	120µs - Comparable/within typical TENS ranges.
Phase Duration (Step-2): Comparable to predicates.	480µs - Comparable/within typical TENS ranges.
Maximum Current Density (mA/cm², r.m.s.): Comparable to predicates (<10mA @500 Ω).	0.12 mA @ 500 Ω - Meets criterion (<10mA).
Maximum Average Current (average absolute value), mA: Comparable to predicates (<10mA @500 Ω).	1.6 mA @ 500 Ω - Meets criterion (<10mA).
Compliance with FDA Recognized Standards for safety, EMC, programmable systems, nerve/muscle stimulators, and biocompatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10, ISO 10993-1, ISO 10993-5, ISO 10993-10).	Declares conformity to all listed standards. - Meets criterion implicitly.
Substantial equivalence to predicate device functionalities and intended use.	Demonstrated through comparison table (e.g., TENS device power source, number of output modes, software, automatic shut-off, user override, indicators, timer range, weight, dimensions, housing material).

2. Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for substantial equivalence, not a clinical study on a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical performance is not established in this type of submission.

4. Adjudication method for the test set: Not applicable.

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 diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: For the technical specifications, the "ground truth" is the established electrical and physical properties of the device as measured and tested against recognized standards and the specifications of predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In essence, the "study" proving the device meets acceptance criteria (as determined by the FDA for TENS devices in a 510(k) context) is the technical comparison presented in the predicate comparison table and the declaration of conformity to established safety and performance standards. It demonstrates that the WiTouch™ Pro is as safe and effective as previously cleared TENS devices already on the market, based on its electrical characteristics and design.

Summary

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510(k) Summary per 21 CFR 807.92

510(k) # K120398

Page 1 of 4

AUG 1 6 2012

Hollywog, LLC 510(k) SUBMITTER: 2830 Amnicola Highway Chattanooga, TN 37406

ESTABLISHMENT REGISTRATION: 3008585473

Michael W. Treas. CONTACT: Chief Compliance Officer

DATE PREPARED: August 15, 2012

PROPRIETARY NAME: WiTouch™ Pro

PANEL: Neurology

REGULATION NUMBER: CFR Title 21, 882.5890

CLASSIFICATION: Class II

PRODUCT CODES: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief); NYN (Stimulator, Electrical, Transcutaneous, For Arthritis)

COMMON NAME: Transcutaneous electrical nerve stimulator for pain relief.

Description:

Indications for Use:

Intended Use:

The intended use is to provide analgesic electrical stimulus to reduce the perception of back pain by electrically stimulating peripheral nerves across the skin (transcutaneously).

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510(k) Summary per 21 CFR 807.92

510(k) # K120398

Page 2 of 4

Accessories:

The device utilizes hydrogel pads) for achieving the indications for use and intended use. The composition of the gel-pads is common materials found in the electrode industry. The uniqueness of the gel-pads is in the shape. The maximum average power density of the electrodes with the gel-pads applied is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns which is consistent with the referenced predicate devices.

510(k) #	Predicate ProprietaryTrade Name	Predicate Regulation, Classification, and Product Code(s)
K061650	Empi SELECT®	CFR Title 21, Sec. 882.5890, Class II, GZJ, NYN
K061516	Staodyn® Max Preset TENS	CFR Title 21, Sec. 882.5890, Class II, GZJ, NYN
510(k) Number	K120398	K061650	K061516
Device Name and Model	WiTouch™ Pro	Empi® Select	Staodyn®Max preset TENS
Manufacturer	Hollywog	EMPI	Compex Technologies
TENS Device Power Source (DC battery)	Battery 1.5VDC(2-Alkaline AAA)	Battery 1.5VDC(3-Alkaline AAA)	Battery 1.5VDC(3-Alkaline AAA)
Number of Output Modes	4	4	4
Number of Output Channels: Synchronous or Asynchronous?	1 Channel Asynchronous	2 Channels Asynchronous	2 Channels Synchronous
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes
Automatic Shut Off?	Yes	Yes	Yes
User Override Control?	Yes	Yes	Yes
Indicator On/Off Status?	Yes	Yes	Yes
Display: Low Battery?	Yes	Yes	No
Voltage/Current Level?	No	No	No
Timer Range (minutes)	30	1 to 30	1 to 30
Weight (lbs., oz.)	4.8 oz.w/ batteries included	4.9 oz.w/ batteries included	5.15 oz.w/ batteries included
Dimensions (in.) [W x H x D]	7.5"(W) x 3.5(H)" x0.7"(D)	2.38"(W) x 1.38"(H) x4.31"(D)	2.5"(W) x 5.25"(H) x1.0"(D)
Housing Material and Construction	Silicone & ABS	Plastic	Plastic
Waveform (e.g., pulsed monophasic, biphasic)	Pulsed biphasic	Pulsed biphasic	Pulsed biphasic
Shape (e.g., rectangular, spike, rectified sinusoidal)	Square	Square	Square
For multiphasic waveforms only: Symmetrical phases?	No	No	Yes
Step-1 and Step-3Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical)	120μs	0 to 400μs at 50% peak amplitude	0 to 300μs
Step-2Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical)	480μs	0 to 400μs at 50% peak amplitude	0 to 300μs
Maximum Current Density, (mA/cm², r.m.s.)	0.12mA@500 Ω	<10mA @500 Ω	<10mA @500 Ω
Maximum Average Current (average absolute value), mA	1.6mA@500 Ω	<10mA @500 Ω	<10mA @500 Ω
Maximum Average Power Density, (W/cm²), (using smallest electrode conductive surface area)	0.00069W/cm2@ 500 Ω	<0.25 W/cm2 at 500 Ω	<0.25 W/cm2 at 500 Ω

Substantially Equivalent Predicate Devices

The predicate devices utilize flexible wires between the electrical stimulus generator: thus. increases the indications for use to the lower back and to body surfaces with greater ranges of motion (e.g., knee, shoulder, elbow, and hip).

The intended design of the WiTouch" Pro device limits the application for use to the anatomical sites of the upper and lower back. The design includes carbon rubber electrodes that are intended for reuse and are permanently-affixed to a rigid surface of the electrical stimulus generator. The unique connection makes the electrodes integral to the generator. The connection and shape of the electrodes limit application of the device to the contours of the back. These unique characteristics of the integral electrodes are insignificant as it relates to safety and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices.

The referenced predicate devices utilize affixed buttons as the sole method to control the electrical stimulus generator on/off and intensity up/down. The WiTouch™ Pro utilizes an additional method of a wireless remote control radio frequency transceiver to control the electrical stimulus generator on/off and intensity up/down. The transceiver operates in the ISM radio frequency band for wireless medical technology. This uniqueness of controlling the electrical stimulus generator by utilizing a radio frequency transceiver is insignificant as it relates to safety .and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices

The characteristics of the analgesic electrical stimulus output between the device and the referenced predicate devices are substantially equivalent as it relates to safety and effectiveness.

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510(k) # K120398

: Page 3 of 4

Technological characteristics and physical properties of the WiTouch Pro device and the referenced predicate devices:

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510(k) # K120398

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Declarations of Conformity

The device complies with the following FDA recognized standards:

FDA Recognized Number 5-4. IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988 Amendment 1, 1991-11, Amendment 2, 1995. (General)

FDA Recognized Number 5-60, IEC 60601-1-2 Int. 1 Third Edition/I-SH 01:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Interpretation Sheet. (General) .

FDA Recognized Number 5-41. Medical electrical equipment - Part 1-4: General requirements for safety- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)

FDA Recognized Number 17-5. IEC 60601-2-10 1987/Amendment 1 2001. Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. (Neurology)

FDA Recognition Number 2-156: AAMI/AMSI/ ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. (Biocompatibility)

FDA Recognition Number 2-153 (Electrodes) ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)

FDA Recognized Standard 2-173 (Electrodes) Recognition Number 2-173: AAMI / ANSI / ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. (Biocompatibility)

Truthful and Accurate Statement

A statement was included in the Premarket Notification attesting to the truthfulness and accuracy of the information provided.

Further Information

In the event that additional information is required, please contact:

Michael W. Treas Chief Compliance Officer Hollywog, LLC 2830 Amnicola Highway Chattanooga, TN 37406

Telephone: (423) 305-7778 ext. 108 Fax: (423) 305-7867 E-mail: mike.treas@hollywog.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

AUG 1 6 2012

Hollywog, LLC Mr. Michael Treas Chief Compliance Officer 2830 Amnicola Highway Chattanooga, TN 37406

Re: K120398

Trade/Device Name: WiTouch Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous nerve stimulator, for pain relief Regulatory Class: II Product Code: GZJ, NYN Dated: July 10, 2012 Received: July 12, 2012

Dear Mr. Treas:

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 may of subject to 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 r loase be devilou that I broundan that your device complies with other requirements of the Act that I Drivias intact a and regulations administered by other Federal agencies. You must

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Page 2 – Mr. Michael Treas

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Kesia Alexander

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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K120398

Device Trade Name: WiTouch® Pro

Indications for Use:

The WiTouch® Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.

Prescription Use(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120398

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).