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The 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.

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.

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).

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The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:

• · Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
• Temporary reduction in the appearance of cellulite. ●

The InMode WMbody device is designed to deliver mechanical vacuum skin massaging and nonthermal RF energy to the skin and subdermal fat. RF energy does not cause thermal damage to the treated skin and adipose tissue.

The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of large tissue surfaces.

The InMode WMbody device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a vacuum pump, vacuum chamber with two electrodes and a pressure sensor.

Following are the InMode WMbody device specifications: RF Output Power: 10-50 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 36cm W x 36cm D x 100cm H (14.2" W x 14.2" D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Inout Voltage (nominal): 100-240 VAC

The provided document is a 510(k) summary for the InMode WMbody device, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device has similar technological characteristics, performance, and safety features as an already cleared device, rather than performing a de novo study with strict acceptance criteria and clinical trials in the way one might expect for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics (like sensitivity, specificity, accuracy) is not directly applicable or explicitly stated in this document.

Instead, the "acceptance criteria" here implicitly refers to demonstrating substantial equivalence to the predicate device, the Viora Reaction System (K090221). The "study" demonstrating this involves non-clinical (bench) performance data and a comparative analysis of specifications and safety.

Here's an analysis based on the information provided, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, explicit performance acceptance criteria in terms of diagnostic accuracy or clinical efficacy are not provided in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device based on technical specifications and safety.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Clinical Performance Data: "Not Applicable." The document explicitly states that clinical performance data was not used for this submission.
  • Non-Clinical (Bench) Performance Data: The sample size for the bench test is not specified, nor is the number of units tested. It simply states "A bench test was performed."
• Data Provenance:
  • Clinical: Not applicable.
  • Non-Clinical: Performed by the manufacturer (InMode MD Ltd.). Country of origin is likely Israel, where the applicant is located. It is inherently a prospective test performed for the regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable. Since clinical performance data was deemed "Not Applicable" for this 510(k) submission, there was no clinical test set requiring expert ground truth establishment. The non-clinical bench test involved comparing instrument measurements.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set or subjective assessment requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. A MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Not Applicable."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implicitly, for certain aspects. The "standalone" performance here refers to the device's inherent technical capabilities rather than a diagnostic algorithm. The non-clinical bench test assessed the device's RF output parameters (power, frequency) in a standalone manner, comparing them to the predicate device's specifications. This is a technical performance test, not a diagnostic algorithm performance.

7. The Type of Ground Truth Used

• For Non-Clinical Bench Test: The "ground truth" was the specifications and measured performance of the predicate device (Viora Reaction System) and the expected electrical/mechanical engineering specifications for the InMode WMbody device itself. The goal was to show that the InMode device's technical specifications and output were "the same" as or "substantially equivalent" to the predicate.
• For Clinical Efficacy: Not applicable, as clinical data was not submitted.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (energy delivery system), not an AI algorithm requiring a training set in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See point 8).

Summary of Approach:

This 510(k) submission for the InMode WMbody device followed the substantial equivalence pathway, which often does not require new clinical studies if the device's technological characteristics, indications for use, and safety profile are demonstrably similar to a legally marketed predicate device. The primary "proof" relies on non-clinical (bench) testing to show that the device meets the same technical standards and performance as the predicate, along with compliance with recognized safety standards.

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