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The InMode System with the WMbody Handpiece and the MiniFX Handpiece is intended for the treatment of the following medical conditions using non thermal 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 InMode System with the MiniFX Handpiece is designed to deliver non-thermal RF energy and mechanical vacuum skin massaging to the skin and subdermal fat. The device provides individual adjustment of non-thermal RF power to achieve maximum efficiency and safety for each patient. The ergonomic MiniFX Handpiece allows efficient treatment of the indicated body areas.

The InMode System with the MiniFX Handpiece consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpiece comprises a vacuum pump, vacuum chamber with two bipolar RF electrodes including a pressure and temperature sensors.

The MiniFX Handpiece is operated while continuously moving it over the treatment area. This ensures a uniform non-thermal RF energy distribution on the entire treatment area. The MiniFX Handpiece is comprised of the hand piece handle, a cable 250 cm long, and a connector which connects to the rear connector of the InMode System (FDA cleared K131362).

The provided text is a 510(k) summary for the InMode System MiniFX Handpiece. It focuses on demonstrating substantial equivalence to a predicate device (InMode WMBody, K131362) rather than establishing novel performance criteria or conducting studies to prove a device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, the information required to answer the prompt for an AI/ML device (e.g., acceptance criteria for AI performance, sample size for test sets, expert ground truth establishment, MRMC studies) is not present in the provided document. The document describes a physical medical device that uses radiofrequency (RF) energy and massage for therapeutic purposes, not an AI/ML algorithm.

The document's "Performance Data" sections state:

• Non-Clinical (Bench) Performance Data: Bench tests were conducted to evaluate RF power output and temperature profile changes. The acceptance criteria here would be matching the predicate device's RF output specifications and maintaining a maximal temperature of 41°C.
• Pre-Clinical (Animal Study) Performance Data: Not Applicable
• Clinical Performance Data: Not Applicable

The "Conclusions" section reiterates that substantial equivalence was demonstrated through device performance tests, primarily bench tests for RF output and temperature, and safety compliance.

In summary, the provided document does not contain the information requested in the prompt because it pertains to a physical medical device (RF and massage) and its substantial equivalence to another physical device, not an AI/ML diagnostic or prognostic algorithm.

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