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The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is intended for use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities, including vein discission and paratibial fasciotomy.

The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities are manually operated, reusable surgical devices consisting of a rigid endoscope, sheath, scissors, forceps, knives, and adapters. The instruments and endoscope are long enough to gain access to the surgical site. 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 document is a 510(k) summary for the "KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities." This document is a regulatory submission for a medical device (surgical instruments) and not for an AI/ML-driven software device.

Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set), which are standard for evaluating AI/ML models, is not applicable to this submission.

The document focuses on:

• Device Description: Manually operated, reusable surgical devices (endoscope, sheath, scissors, forceps, knives, adapters).
• Indication: Use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities.
• Substantial Equivalence: Comparison to predicate devices, stating that minor design differences do not raise new safety or effectiveness issues.

There are no acceptance criteria, performance metrics, or study methodologies for an AI/ML algorithm mentioned or implied in this document.

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