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The KSEA instrument set for arthroscopic percutaneous discectomy is designed to visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control.

The KSEA instrument set for arthroscopic percutaneous discectomy are manually operated, reusable surgical devices consisting of arthroscopes, forceps, cannulae, sheaths, dilation sheaths, trephines, puncture needles and curettes. The 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 are surgical grade stainless steel or chrome plated brass.

This document is a 510(k) summary for a set of surgical instruments, not for an AI/ML powered medical device. Therefore, the questions regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC studies are not applicable.

The document describes the intended use and device characteristics of the Karl Storz Endoscopy instrument set for arthroscopic percutaneous discectomy. It highlights the substantial equivalence to predicate devices, stating that minor design and dimensional differences do not raise new safety or effectiveness issues.

Therefore, I cannot provide the requested information as it pertains to a different type of medical device evaluation than what is presented in the provided text.

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