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The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The device consists of the same four principal components as the ThermaCool and The ThemaCool II as reviewed under the referenced earlier premarket notifications. The four principal components are:
The Thermage ThermaCool IIA RF Generator
The Thermage ThermaCool IIA Handpiece Connection Module
The Thermage ThermaCool IIA RF Cooling Module
The Thermage ThermaCool IIA RF Handpiece Assembly
The device generates radio frequency (RF) energy and operates in either monopolar or bipolar mode as selected by the user. The device continuously monitors output energy, treatment duration, and measured impedance. When used in monopolar mode, a commercially available dispersive patient return electrode is implemented. When used in bipolar mode, current flows via the handpiece insert tip and no dispersive electrode is needed. The handpiece attaches to the unit via an industry standard BNC type connector. As before, the intended use of the device is for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The system has been modified and now includes a heating element and a new cryogen metering valve within the handpiece. The effect of the change is improving cryogen flow characteristics in the clinical setting.

The provided text is a 510(k) premarket notification for the ThermaCool IIA device, which is an electrosurgical cutting and coagulation device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a formal clinical study with performance metrics as one might find for a novel device or software.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

The submission states:

• "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
• "However, voluntary standards such as in-house Standard Operating Procedures and device and accessories. Trowerer, velazary of and utilized in the production of the device."

This indicates that the manufacturer relies on internal, voluntary standards rather than externally defined performance criteria for this specific type of device in this context. The core of the 510(k) submission is to demonstrate that the ThermaCool IIA is substantially equivalent to the previously cleared ThermaCool II (K000944 & K003183), especially regarding a modification related to a heating element and cryogen metering valve to improve cryogen flow characteristics.

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