(449 days)
Radio Frequency Plasma Surgical Systems are indicated for cutting, resection, ablation and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology head and neck surgery procedures. Radio Frequency Plasma Surgical Electrodes are used in combination with the compatible RF or Plasma device for cutting, resection, vaporization, ablation and coagulation of soft tissues and hemostasis of blood vessels in otorhinolaryngology head and neck surgery procedures.
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The provided text is a U.S. FDA 510(k) clearance letter for "Radio Frequency Plasma Surgical Systems" and "Radio Frequency Plasma Surgical Electrodes." This document primarily covers the regulatory approval of the devices and their intended use. It does not contain information about acceptance criteria, clinical study results, sample sizes, ground truth establishment, or expert qualifications for a study proving device performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is a regulatory communication, not a scientific or clinical study report.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.