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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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The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).

The KSEA vaporization electrodes are manually operated, singleuse instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness.

The provided text is a 510(k) summary for Karl Storz Endoscopy vaporization electrodes. It does not contain any information about acceptance criteria, device performance metrics, or a study that proves the device meets specific performance criteria.

The document primarily focuses on:

• Applicant and contact information.
• Device identification (Common Name: Endoscopic electrodes).
• Indications for Use: Cutting prostate tissue, superficial bladder tumors, and cauterizing minor bleeding in the prostate and bladder.
• Device Description: Manually operated, single-use, sterile accessories to resectoscopes, with body contact materials having a long history of use.
• Substantial Equivalence: Claims substantial equivalence to predicate devices based on similar basic features, design, and intended uses, asserting that minor differences do not raise new safety or effectiveness issues.

Therefore, it is not possible to answer any of the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text. The document is a regulatory submission summary, not a performance study report.

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