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The Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides

The Imagine Skin Treatment System is a noninvasive, non-ablative device consisting of: User interface Programmable Logic controller (PLC) RF power module Thermoelectric cooling (TEC) module Two treatment handpieces (small and large) The interface allows the selection of treatment parameters by pressing on the treatment buttons; LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. Handpieces incorporating: Treatment handpieces with thermoelectric cooling (TEC) that maintains electrodes at ambient temperature. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 1000 kHz frequency

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical performance study with specific metrics, sample sizes, and expert adjudication.

Instead, the document states:

1. Reliance on Predicate Devices: "Substantial equivalence to the following predicate devices is claimed."
2. Established Safety and Efficacy: "The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1000 KHz with power of 10 to 100 W is well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides."
3. No New Animal or Clinical Studies: "Due to the comprehensive animal and clinical study performed in scientific research and published in the literature, and since the power and frequency of the Imagine TC Skin Treatment System are well within the previously cleared values, EndyMion believes that animal and clinical studies are not required to determine the safety and efficacy of the device."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a specific study conducted for this particular device as requested in the input prompt. The FDA clearance was based on substantial equivalence to existing predicate devices and the generally established safety and efficacy of similar technology.

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