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The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.

The Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The Linvatec 300W Xenon Light Source is capable of interfacing with the ConMed I.S. Operating Room Control System to allow an alternate means for user control.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec 300W Xenon Light Source. This document describes a medical device submission seeking substantial equivalence to predicate devices, rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training data cannot be extracted from this document as it does not contain such information.

The document states: "The differences between the Linvatec 300W Xenon Light Source and the predicate devices are minor and raise no new questions of safety and effectiveness." This indicates that the regulatory review focused on the similarity to already approved devices, rather than requiring a detailed performance study against new acceptance criteria.

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