(43 days)
The SB Knife® is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703 W, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.
The SB Knife® is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703 W, MD-47706 and MD-47703L).
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for the SB Knife®, which states that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and indications for use, but it does not include performance study data, sample sizes, expert qualifications, or details about how ground truth was established, which are necessary to answer your request.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).