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The EntriPort Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments. The Trocar may be used with or without visualization for primary and secondary insertions.

The EntriPort Mini Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments.

The EntriPort Surqical Trocar System is a broad range of surgical trocars and accessories intended for use as the means for providing surgical access for various instruments during endoscopic surgery.

The EntriPort Surgical Trocar System includes both full size and mini devices, which are available in disposable (single patient use) and reposable (at least one reusable, and one disposable component) configurations. Reusable components are limited to the Reusable Cannula and accessories of the Open Entry (Hasson) Trocar.

This document, a 510(k) Summary for the ConMed EntriPort Surgical Trocar System (K142464), details a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not present in this document.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table with specific, quantifiable acceptance criteria and reported device performance linked to those criteria for an AI device. Instead, it states that "Product performance testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, AAMI/ANSI ST81:2004(R)2010, ISO 10993-7:2008, ISO 14971:2007, ISO 594/1:1986, and ISO 594-2:1998." It also mentions "Performance testing, including blade insertion forces, entry wound defect size, instrument insertion and removal, maintenance of pneumoperitoneum, and trocar insufflation rate, demonstrates the device performance is substantially equivalent to the predicate devices."

This is general and focuses on compliance with existing standards and substantial equivalence to a predicate, not on novel performance metrics for an AI system.

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

This information is not provided. The document describes non-clinical bench and simulated use testing, but it does not specify sample sizes for these tests, nor does it refer to "test sets" or "data provenance" in the context of an AI study.

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)

This information is not provided. The document does not describe the establishment of a ground truth by experts, as it is not a study evaluating an AI algorithm's diagnostic or predictive capabilities.

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

This information is not provided. Again, this is relevant for studies involving human interpretation or consensus, which is not described here for an AI device.

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

No such study was done or reported. This document is for a surgical trocar system, not an AI-powered diagnostic or assistive tool.

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

No standalone algorithmic performance study was done or reported, as the device is a physical surgical tool, not an algorithm.

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

No "ground truth" in the context of AI evaluation is mentioned or used. The evaluation focuses on the physical and functional aspects of the surgical trocar system against established engineering and medical device standards.

8. The sample size for the training set

This information is not provided. The concept of a "training set" is not applicable to a physical surgical device like a trocar.

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

This information is not provided, as there is no "training set" or "ground truth" for an AI algorithm discussed in this document.

In summary:

This 510(k) document is for a surgical trocar system, which is a physical medical device. It is not an AI-powered device, and therefore, the information typically requested for evaluating the acceptance criteria and study data of an AI device (like test/training sets, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present in this document. The document focuses on demonstrating substantial equivalence to an existing predicate device based on technical characteristics, materials, intended use, and compliance with general medical device standards.

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