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The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.

The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.

This document is a 510(k) summary for a medical device (Karl Storz Multidrive Mini Shaver and blades). It describes the device's intended use and design but does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/machine learning devices or software.

This document is from 1997 and pertains to traditional surgical equipment, not AI/ML-driven medical devices. Therefore, the questions regarding acceptance criteria, study design, sample sizes, ground truth, expert consensus, MRMC studies, or standalone performance are not applicable to the information provided in this 510(k) summary.

The summary states that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are established by demonstrating similarity to already legally marketed devices, rather than through a new clinical performance study as would be required for novel AI-based devices.

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