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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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