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The Inbella RF System is indicated for use in dermatological and general surgical procedures where coagulation/contraction of soft tissue or hemostasis is needed.

The Inbella RF System is a computerized system generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring electrocoagulation/contraction of soft tissue and hemostasis. The Inbella RF System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating. The Inbella RF System consists of an AC/DC power supply unit, RF generator, controller and user interface including touch screen. The RF handpiece is connected to the console via a cable and a foot switch activates the energy delivery to the handpieces are available, all comprised of a disposable, single use plastic handle with active internal electrodes. A subset of handpieces have both internal (active) and external (return) electrodes.

This device, the Inbella RF System, is an electrosurgical cutting and coagulation device. The provided text, a 510(k) summary, explicitly states that no clinical performance data, non-clinical (bench) performance data, or animal performance data were submitted to support this submission.

The basis for this 510(k) clearance is that the Inbella RF System is identical in all aspects to the predicate device, the InMode RF System (K240780), with the only difference being the manufacturer and 510(k) holder. Therefore, the acceptance criteria and the study proving the device meets those criteria would refer to the predicate device (InMode RF System, K240780), not the Inbella RF System itself.

Since the provided document is for the Inbella RF System and explicitly states no new performance data was submitted, I cannot extract the detailed information requested regarding the acceptance criteria and study data for this specific device.

To provide the requested information, you would need to access the 510(k) summary for the predicate device, InMode RF System (K240780). Without that information, I cannot complete the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details for the Inbella RF System.

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