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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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