(38 days)
Excise tissue and coagulate tissue.
Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle is used in coniunction with an electrical generator to excise tissue and coagulate bleeding.
This document, K963901, is a 510(k) summary for a medical device: "Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle." It primarily addresses substantial equivalence to a pre-amendment device (K901505) and discusses minor changes related to labeling and user convenience.
However, this document does not contain the information required to answer your prompt.
Here's why:
- No acceptance criteria or device performance data: The document doesn't present any specific performance metrics (e.g., sensitivity, specificity, accuracy, surgical success rates) or associated acceptance criteria. It merely states the device's function and intended use.
- No study details: There is no mention of any clinical or performance studies, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods. The document is strictly a regulatory submission focused on demonstrating substantial equivalence based on prior approvals and minor, non-functional changes.
- Not an AI/algorithm-driven device: This device is an electrosurgical probe and handle, a physical instrument for surgery. It is not an AI or algorithm-based diagnostic or assistive technology, which are the types of devices typically associated with the detailed performance evaluation criteria you've listed (e.g., standalone performance, MRMC studies, training/test sets for algorithms).
Therefore, I cannot populate the table or answer the specific questions from your prompt based on the provided text.
§ 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.