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The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.

Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.

The device consists of a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft.

The Sleeve, proportionally sized, is made of polymer, threaded and contains an insufflation port . There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer.

The provided text is a 510(k) summary for a medical device (Secondary Trocar and Sleeve with Insufflation Port). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo performance studies with defined acceptance criteria. The summary states: "The usage of this product is identical to previous devices, which have the same technological characteristics" and "The following technological characteristics are the same or equivalent as predicate devices."

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance. The concept of a "test set" for performance evaluation against acceptance criteria is not present here.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone (algorithm only) performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is purely a regulatory submission claiming equivalence based on design and intended use, not a performance study report.

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