(105 days)
The ACCU-Surg Bipolar Laparoscopic Electrodes are intended to be used with the ACCU-Surg Suction / Irrigation Cannula. They are surgical tools for cutting and coagulation used for GYN and General Surgery for such procedures as coagulation of endometrium, laparoscopic myomectomy, laparoscopic leiomyoma coagulation (myolysis), bleeding control of pelvic vessels and laparoscopic (**) errors )) bacanth orgeons choice will determine the tip style used.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "ACCU-Surg Bipolar Laparoscopic Electrodes." It primarily addresses regulatory aspects and does not contain information about acceptance criteria or a study proving device performance in the context of the requested details (e.g., sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance).
Therefore, based solely on the provided text, I cannot describe the acceptance criteria or a study proving the device meets those criteria with the level of detail requested in your prompt. The document only states that the device is "substantially equivalent" to predicate devices, which is a regulatory determination, not a clinical performance assessment in the manner you're asking for.
The information you are requesting typically comes from detailed clinical trial reports or FDA 510(k) summaries which contain performance data and methodologies, none of which are present in this specific clearance letter.
§ 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.