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The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.

Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery. gynecology, and urology. The trocars are made from biocompatible materials. They are available as reusable in 3.5, 5, 10 or 12mm diameter with lengths of 60, 110, and 150mm. The trocars are offered with or without a stopcock, and threaded or smooth. The devices are color coded for easy identification.

This 510(k) submission (K101937) for the Aesculap Hybrid Trocar System does not include any data from a clinical study or performance data to prove the device meets acceptance criteria.

The document explicitly states:

"No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices."

This indicates that clinical acceptance criteria and subsequent studies demonstrating their fulfillment were not a requirement for this particular submission. The substantial equivalence was established by comparing the device's technological characteristics to existing predicate devices (K942053, K982623, and K071976).

Therefore, I cannot provide the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, etc., as it is not present in the provided document.

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