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The "ESDP" instrument set is used for minimally invasive visualization and diagnostic and therapeutic procedures of superficial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

The device consists of an operating telescope, endoscopic operating tube, a laser guide, and a hook knife.

The provided text does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document is a 510(k) summary for a medical device (Instruments for Endoscopic Subfascial Discission of Perforating Veins (ESDP)) and explicitly states:

• "Performance Data 5.0 No data generated."
• "Clinical Tests 6.0 No clinical tests performed."
• "Data Conclusions 7.0 No data available."

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. This device was cleared based on substantial equivalence to predicate devices, not on performance data from a specific study against acceptance criteria.

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