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The KSEA Large Joint Arthroscopy Set is intended for arthroscopic procedures of the shoulder, knee and is also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.

The Karl Storz Large Joint Arthroscopy Set are manually operated surgical devices. The KSEA Large Joint Arthroscopy Set is composed of Forward-Oblique 30° enlarged view Telescopes, Lateral 70° enlarged view Telescopes, Arthroscope Sheath with sharp and blunt obturators, Grasping and Biopsy Forceps, Trocar, and Inflow Cannula. The body contact portions of the KSEA Large Joint Arthroscopy Set 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 submission is for an arthroscope, a manually operated surgical device. As such, it does not rely on AI/ML and therefore the requested information regarding acceptance criteria, study data, and AI/ML specific details (sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on similar features and intended uses, without mentioning any performance metrics that would typically be associated with AI/ML device approval.

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