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The InMode EmBody System with its designated hand pieces is intended for the treatment of the following medical conditions;

The EmBodyPLUS hand piece is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

The EmBodyFX Hand piece is intended for the treatment of the following medical conditions using RF combined with massage:

· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

· Temporary reduction in the appearance of cellulite.

The EmBody System with the EmBodyFX and EmBodyPlus Applicators is a free hand, easy to operate system, designed to deliver non-thermal RF energy to the skin and subdermal fat. The EmBodyFX Applicator also incorporates a mechanical vacuum skin massaging mechanism.

The EmBody System is employing RF technology for various aesthetic applications.

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

The EmBody System consists of an AC/DC power supply unit, two RF generators, controller and user interface including an LCD touch screen. The System RF noninvasive applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a Start/Stop button located on the LCD screen.

The EmBody System operates while connected to any of the following Applicators:

• . EmBodyFX (Up to Six units connected simultaneously) or;
• . EmBodyPlus (Up to Eight units connected simultaneously)

Each applicator unit is connected to the main console via a designated cable and a connection port. The applicator units are adjusted to the patient body using a designated belt set.

The provided text describes the EmBody System, which is intended for temporary relief of minor muscle aches and pain, muscle spasms, local blood circulation improvement, and temporary reduction in the appearance of cellulite. The device uses non-thermal RF energy and, in the case of the EmBodyFX applicator, a mechanical vacuum skin massaging mechanism.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and proving safety and effectiveness through various tests.

However, based on the non-clinical and clinical studies, the implied performance outcomes and safety parameters could be considered acceptance criteria and reported performance:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set:
  • Bench Test (Thermal Effect Comparison): The text mentions "human volunteers" but does not specify the sample size for this comparative bench test.
  • Ex-vivo Animal Study: Not specified, but involved "porcine tissue."
  • Human Clinical Study: Thirty (30) eligible human subject participants.
• Data Provenance:
  • Bench Test (Thermal Effect Comparison): Conducted in-house by the manufacturer (InMode MD Ltd.) comparing their own devices. Specific country of origin not explicitly stated, but the manufacturer is based in Israel.
  • Ex-vivo Animal Study: Conducted in-house by the manufacturer. Specific country of origin not explicitly stated, but the manufacturer is based in Israel.
  • Human Clinical Study: Conducted in-house by the manufacturer. Specific country of origin not explicitly stated, but the manufacturer is based in Israel. This was a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The provided text does not mention using experts to establish ground truth for the test set. The evaluation was based on:

• Thermal measurements.
• Skin observation.
• Tissue vitality evaluation (in the animal study).
• Adverse event reporting.
• Subject discomfort levels.

Therefore, no information on the number or qualifications of experts for ground truth establishment is available.

4. Adjudication method for the test set

The provided text does not mention any adjudication method for the test set. The safety and performance assessments were directly observed (e.g., thermal measurements, skin observation, adverse event reporting) rather than requiring independent review or consensus.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is an electrosurgical device for aesthetic and therapeutic applications, not an AI-powered diagnostic imaging tool that would typically involve human readers or AI assistance in interpretation.

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

This refers to a physical medical device, not an algorithm or AI. Performance was assessed through direct physical interaction with tissue (bench, animal, and human studies), not through an algorithm operating independently. Therefore, this question is not applicable.

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

The ground truth for evaluating the device's safety and performance was primarily based on:

• Physiological measurements: Thermal measurements (temperature around 43°C).
• Direct observation: Skin observation for transient responses, absence of tissue necrosis, and absence of adverse events.
• Subjective reporting: Discomfort levels reported by human subjects.
• Comparison to predicate devices: Demonstration of "similar thermal effect" and "same thermal outcomes" as the legally marketed predicate devices.

8. The sample size for the training set

The provided context describes performance testing for device clearance, not the development or training of an AI model. Therefore, there is no "training set" in the context of this document.

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

As there is no training set for an AI model, this question is not applicable.

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