(126 days)
The Soniquence Bipolar Electrode is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.
The Soniquence Bipolar Electrodes family is a line of disposable bipolar electrosurgical devices which is intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. The basic design of the Soniquence Bipolar Electrodes is a plastic handle, an elongated, insulated electrode shaft, a bipolar electrode tip, and an integrated cable and plug which is designed to connect exclusively to the Soniquence line of high-frequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Soniquence Bipolar Electrode emits RF energy generated according to settings established on the Soniquence RF generator which emits high frequency, low temperature radiowaves directed to the electrode tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. This energy is capable of cutting or coagulating target tissue depending on the waveform associated with the mode and power setting of the generator. The devices are disposable and intended for single-use only. The devices are intended for transient contact with the patient, and are provided sterilized by ethylene oxide and has a shelf life of three years from the date of sterilization.
The provided text describes a 510(k) summary for the Soniquence Bipolar Electrodes and primarily focuses on non-clinical testing and substantial equivalence to predicate devices. It explicitly states in section "Clinical Testing (807.92(b)(2))" that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
Therefore, the input document does not contain the information requested regarding acceptance criteria related to device performance in a clinical setting, a study proving the device meets these criteria, sample sizes for test or training sets, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training data was established. The document focuses on bench testing and material biocompatibility.
Based on the provided text, I am unable to fulfill the request as it pertains to clinical performance evaluation.
§ 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.