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These instruments are intended for use by qualified surgeons during Ob/Gyn hysteroscopic surgical procedures including:

• abnormal uterine bleeding, ●
• . infertility,
• transuterine resection of fibroids, .
• . endometrial ablation,
• resectoscopic management of Mullerian fusion defects, .
• resectoscopic management of intrauterine lesions, and .
• resectoscopic management of intractable uterine bleeding. .

The KSEA Monopolar Vaporization Electrodes are manual single-use sterile surgical devices. The body contact materials are surgical grade stainless steel, tungsten, and a copper/nickel alloy. The Monopolar Vaporization Electrodes are insulated with commonly used materials.

The provided document is a 510(k) summary for the KSEA Monopolar Vaporization Electrodes. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed clinical study demonstrating acceptance criteria and device performance in the context of, for example, an AI/ML medical device.

Therefore, the specific information requested, such as a table of acceptance criteria and reported device performance based on a study, sample size for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

The document states: "The minor differences in design and dimensions between the KSEA Monopolar Vaporization Electrodes and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices." This indicates that the regulatory submission primarily relies on the equivalency to existing, legally marketed devices, rather than a new clinical study with defined performance metrics and acceptance criteria for a novel device or AI/ML algorithm.

Therefore, I cannot provide the requested information based on the provided text.

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