(74 days)
Simultaneous cutting and cauterization of soft tissue during surgery.
The Cautery Clamp, a hand-held surgical instrument, is powered by a disposable Battery Pack Power Supply. The Cautery Clamp consists of two components that are sold separately: a reusable Surgical Clamp, and a disposable Clamp Insert with power cord. The Cautery Pack Power Supply is intended for the simultaneous cutting and cauterization of soft tissue during surgery, to be used in essentially all major surgical disciplines.
This looks like a 510(k) premarket notification for a medical device. Unfortunately, the provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document is a summary describing the device (a thermal cautery clamp), its intended use, and its substantial equivalence to a predicate device. It also includes the FDA's letter of clearance.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. To answer your questions, I would need a different document, such as a test report, clinical study summary, or a more detailed section of the 510(k) submission that discusses performance data.
§ 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.