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The RFG-01 is intended to:

• provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
• provide, with a massage device, a temporary reduction in the appearance of cellulite.

The RFG-01 is a mobile standalone equipment with four wheels and consists of a console (main unit), a color display with touch operation and three handpieces (small, medium, and large). The device develops localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. The purpose of the treatment based on the radiofrequency system is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the resistive (or bipolar) types. Resistive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The use of different sizes allows efficient and effective treatment of various parts of the body. Two of the three handpieces can be used with or without vacuum, allowing an even deeper application of heat. The handpieces are to be used with a small amount of contact lotion, the purpose of which is to assist in heat transfer. The LEDs on every handpiece indicate the coupling and the correct temperature range during the treatment. The color touchscreen displays all treatment-related parameters.

The provided text is a 510(k) Summary for the Zimmer MedizinSysteme GmbH RFG-01 device. It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document states that "Performance data" and "The following testing has been conducted with satisfactory results:" followed by a list of tests and standards. However, it does not provide specific numerical acceptance criteria or the measured performance results from these tests. It only lists the types of tests performed and the standards met.

Therefore, I cannot populate the table with specific acceptance criteria and reported device performance, nor can I provide details on sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. The document focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison of technological characteristics, not through clinical performance metrics against defined acceptance criteria.

The information regarding acceptance criteria and reported device performance would typically be found in detailed test reports for the validation tests (e.g., RF Power Accuracy, Vacuum Pressure Accuracy, Thermal Effect on Skin testing), which are not included in this 510(k) Summary.

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