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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.

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