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The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

The KSEA Spinoscope is a fiber optic endoscope with a remote eyepiece. The body contact portions of the KSEA Spinoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

This document describes a 510(k) premarket notification for a medical device called the "Karl Storz Spinoscope." A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of submission. The provided text does not contain any information regarding clinical studies, performance metrics, or acceptance criteria in the manner typically associated with device performance evaluations.

The core of this submission is the statement of substantial equivalence:

"The Karl Storz Spinoscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Spinoscope and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."

In summary, none of the requested information can be extracted from the provided text because it is a 510(k) summary for an arthroscope, which focuses on substantial equivalence rather than performance against pre-defined acceptance criteria through a study.

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