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This instrument is a manually operated surgical devices intended for Indications for Use: This mistiument is a manadiy operation soopes during diagnostic and therapeutic neurologic procedures.

Endoscope Holder

The provided document is a 510(k) substantial equivalence letter from the FDA for an "Endoscope Holder." This type of document is a regulatory approval, not a technical report or scientific study detailing acceptance criteria and performance data for a specific medical device's algorithmic capabilities.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment for a device that relies on algorithmic performance.

This document pertains to a manually operated surgical device, an "Endoscope Holder," which is a mechanical device, not a software or AI-driven medical device. The 510(k) process for such a device focuses on demonstrating that it is substantially equivalent to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness, rather than robust clinical trials or performance evaluations of an algorithm.

In summary, none of the requested information can be extracted from the provided text.

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