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The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures 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 Reusable Trocars and Cannula with Insufflation Port with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum. The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch. The Reusable Trocars are constructed with a stainless steel shaft and are available in pyramidal style. The Reusable Shielded Trocar is available with a conical or pyramidal tip. The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.

This document is a 510(k) summary for a medical device (reusable trocars and cannula with insufflation port). It focuses on establishing substantial equivalence to predicate devices, not on proving device performance against specific acceptance criteria through a study.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth cannot be extracted from this document because such a study is not described.

This 510(k) is a premarket submission to demonstrate that the device is as safe and effective as a legally marketed device (predicate device). It relies on technological characteristics being substantially equivalent, rather than presenting a performance study with defined acceptance criteria and statistical outcomes.

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The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The 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 Reusable Trocars and Sleeves, with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.

The Reusable Trocar, sizes 3mm -11mm. , is constructed with a stainless steel shaft and is available in pyramidal style.

The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.

This document is a 510(k) summary for a medical device (Reusable Trocar and Sleeve). It focuses on establishing substantial equivalence to previously marketed devices rather than detailing a specific study to demonstrate performance against predefined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not provided in this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria nor explicit reported device performance against such criteria. The entire purpose of this 510(k) submission is to demonstrate "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as existing legally marketed ones. The "performance" is implicitly deemed acceptable if it's equivalent to the predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no mention of a "test set" or specific sample sizes for performance testing. The claim of equivalence is based on the device's design, materials, and intended use being similar to predicate devices. This type of submission relies on design comparisons rather than clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" establishment by experts for a test set is described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is about a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a manual surgical instrument, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document does not describe the establishment of a "ground truth" in the context of performance testing. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI or machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set or its ground truth establishment.

Summary based on the document:

The provided text from the 510(k) summary focuses entirely on demonstrating the "substantial equivalence" of the Pilling Weck Reusable Trocar and Sleeve to legally marketed predicate devices (Core Dynamics Entree II, Apple Medical Hunt Reich Secondary Trocar, and Access Surgical Access Single Use Trocar and Sleeve). This regulatory pathway typically relies on comparisons of technological characteristics, intended use, and materials rather than extensive de novo clinical performance studies with predefined acceptance criteria. Therefore, the document does not contain the detailed information requested about specific performance studies, sample sizes, expert involvement, or ground truth establishment as would be found for a novel device or an AI/ML product.

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