The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

Device Description

Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following speciallydesigned applicator:

The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

AI/ML Overview

The provided text is a 510(k) summary for the V-Touch device and a letter from the FDA determining its substantial equivalence. This type of regulatory document primarily focuses on demonstrating equivalence to a predicate device based on similar technology, intended use, and safety/performance standards, rather than presenting a detailed clinical study with acceptance criteria and results.

Therefore, the document does not contain the specific information required to complete all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

However, I can extract the following information available in the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific quantifiable metrics for the V-Touch's dermatological procedures or the ST applicator's indications. Instead, it relies on substantial equivalence to a predicate device and compliance with general safety and performance standards.

The document states:

"V-Touch successfully passed validation and verification testing, including testing for RF power accuracy."
"Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device."

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

This information is not provided in the document. The filing focuses on bench testing and substantial equivalence, not a clinical trial with a test set of patient data.

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)

This information is not provided in the document, as no clinical test set with expert-established ground truth is described.

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

This information is not provided in the document, as no clinical test set requiring adjudication 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in the document. The device described is a physical medical device (RF energy system), not an AI-powered diagnostic tool.

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

This is not applicable as the device is a physical medical device, not an algorithm.

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

This information is not provided in the document. For the bench testing, the "ground truth" would likely refer to engineering specifications and performance benchmarks, not clinical outcomes or expert consensus.

8. The sample size for the training set

This information is not provided in the document. The device is not an AI/machine learning model, so there is no "training set" in that sense.

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

This information is not provided in the document, as there is no training set mentioned in the context of AI/machine learning.

Summary regarding information gaps:

The provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (V-Touch) based on shared technology, intended use, and compliance with general safety standards and bench testing. It explicitly states: "Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device."

This type of submission typically does not include detailed clinical study designs with acceptance criteria, patient sample sizes, expert ground truth, or MRMC studies, especially if relying on the substantial equivalence of a previously cleared component (the ST applicator).

Summary

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

October 21, 2014

Viora Ltd. % Yoram Levy Qsite 31 Haavoda Street Binyamina. Israel 30500

Re: K141904

Trade/Device Name: V-Touch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 1, 2014 Received: October 3, 2014

Dear Mr. Levy:

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 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); medical device reporting (reporting of medical

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K141904

Device Name V-Touch

Indications for Use (Describe)	The V-Touch is intended for dermatological procedures.
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temporary improvement of local blood circulation.

The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY

V-Touch

510(k) Number K141904

Applicant's Name:	Viora Ltd.3 Maskit StreetHerzliya, Israel 46733Tel: +972 9955 1344Fax: +972 9955 1345
Contact Person:	Yoram Levy, Qsite31 Haavoda StreetBinyamina, Israel 30500Tel +(972)4-638-8837; Fax (972)4-638-0510Yoram@gsitemed.com

Trade Name: V-Touch
Common Name: Multi application RF Device
Preparation Date: July 08, 2014
Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery

Device Description:

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Intended Use Statement:

The Viora V-Touch is intended for dermatological procedures.

The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

Predicate Devices:

Substantial equivalence to the following predicate devices is claimed:

Device Name	510k No	Date of Clearance
Viora Reaction	K090221	July 1, 2009

Substantial Equivalence to Predicate Devices

The Viora V-Touch includes the ST applicator that is the same applicator that was cleared with the Viora Reaction (K090221).

Performance Standards:

V-Touch complies with

IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety. Collateral Standard: Safety Requirements
for Medical Electrical Systems.

IEC 60601-1-2 Medical Electrical Equipment Part 1-2: ● Collateral Electromagnetic Compatibility - -Standard: Requirements and Tests.

IEC 60601-2-2 - Medical Electrical Equipment-Part 2: ● Particular requirements for the safety of high frequency surgical equipment.

Performance Bench Tests and Conclusions

The V-Touch successfully passed validation and verification testing, including testing for RF power accuracy. Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.