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The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is intended for endoscopic saphenous vein harvesting procedures.
These instruments are manually operated surgical devices intended to be used in procedures for removal of the saphenous vein as a graft in coronary and vascular surgery.

The Karl Storz Instrument Set for Endoscopic Saphenous Vein Harvesting are manually operated surgical devices. The KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting is composed of Forward Oblique (30°) Endoscope, Optical Retractor and Optical Dissector, Vein Dissectors, Grasping Forceps, Dissecting and Grasping Forceps, and Hook Scissors, Take-apart™ Dissecting Forceps, Dissecting and Grasping Forceps, and Scissors, Take-apart® Bipolar Forceps, and Suction Coagulating Cannula. The body contact portions of the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting are composed of surgical grade stainless steel, PTFE, Kynar and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.

The provided text is a 510(k) summary for the KSEA Instrument Set for Endoscopic Saphenous Vein Harvesting. This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics often associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy).

Instead, this document focuses on establishing substantial equivalence to existing predicate devices, which is the regulatory pathway for this type of medical instrument. Substantial equivalence relies on demonstrating that the new device has the same intended use and similar technological characteristics as an already legally marketed device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot provide the requested information from the given text. The K973068 document is for a set of manually operated surgical instruments, not a device that relies on performance criteria like those described in your prompt (e.g., AI algorithms, diagnostic accuracy).

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