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The Karl Storz Powershaver System S2 is intended to provide controlled cutting, shaving and abrading of bone and tissue during arthroscopic surgical procedures of the knee, shoulder, ankle, elbow, wrist, hip, and temporal mandibular joint (TMJ) conducted by qualified surgeons.

The Powershaver System S2 is comprised of a power unit, handpieces, a footswitch, and a power cord. Other accessories include shaver blades, drill chucks, and sagittal saws.

The provided text is a 510(k) summary for the 'KSEA Powershaver System S2', an arthroscopic shaver. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria.

Therefore, we cannot extract the requested information because the document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a study conducted to demonstrate performance against specific criteria.
• Information on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The 510(k) summary focuses on the intended use, device description, and a statement of substantial equivalence based on similar features, design, and intended uses to predicate devices, without presenting evidence from a performance study against specific acceptance criteria.

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