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The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. Due to the increased demand for minimally invasive surgery, trocars have become an essential part of laparoscopic procedures. By providing the surgeon with a fully reusable instrument with replaceable tip such as the PortLand Trocars, SI have optimized the economy of a re-usable instrument, with the advantages of the disposable instrument, in the provision of the replaceable tip concept. The materials used in the construction of the PortLand Trocars are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland. Also, the means of sterilization (autoclaving) has long been used by hospitals for the sterilization of surgical instruments.

This document (K962193) is a 510(k) notification for the PortLand Trocars, a surgical device. The information provided is insufficient to answer the request about acceptance criteria and a study proving device performance against those criteria.

Here's why and what information is missing based on the prompt's requirements:

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

• Missing. The document states "The PortLand Trocars is very similar to all other trocar devices previously found to be substantially equivalent..." and "this instrument is as effective as other competitive product and does not increase the risk to the patient." However, it does not provide specific, measurable acceptance criteria (e.g., force required for insertion, durability, sealing characteristics) nor any data on how the PortLand Trocars performed against such criteria.

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

• Missing. There is no mention of any specific test set, sample size, or data provenance.

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 / Missing. This question is typically relevant for AI/ML-driven diagnostic devices where expert ground truth is established. For a mechanical surgical instrument like a trocar, "ground truth" would be performance specifications, and experts would be engineers or surgeons evaluating usability and safety. This document provides no such details.

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

• Not applicable / Missing. Similar to point 3, this is relevant for diagnostic performance evaluation, not for the type of device described.

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 pertains to AI-assisted diagnostic tools and is not relevant for a surgical trocar.

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

• Not applicable. This pertains to AI/ML algorithms and is not relevant for a surgical trocar.

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

• Missing (and applies differently to this device type). For a trocar, "ground truth" would relate to its physical properties, safety, and functional performance. The document only mentions similarity to other devices and materials.

8. The sample size for the training set:

• Not applicable / Missing. This is typically for AI/ML and is not mentioned for this device.

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

• Not applicable / Missing. This is typically for AI/ML and is not mentioned for this device.

Summary of Document K962193 in relation to the prompt:

This 510(k) notification focuses on demonstrating substantial equivalence to predicate devices. It largely relies on:

• Similar intended use: Both the PortLand Trocars and existing trocars are for laparoscopic procedures.
• Similar technological characteristics: "very similar to all other trocar devices," "materials used... are commonly found in other surgical instruments and are identical with that used in the product manufactured by Mikroland."
• Similar principles of operation: Functionally, it's a trocar.
• Safety and Effectiveness claims: "as effective as other competitive product and does not increase the risk to the patient."

The document does NOT provide:

• Specific, quantified acceptance criteria.
• Results from a formal study (clinical or performance bench testing) with defined methodologies, sample sizes, or outcome measures to prove performance against those criteria.
• Any details related to AI/ML performance, ground truth, or expert evaluations in the context of diagnostic accuracy.

To answer your prompt fully, a different type of document, such as a detailed test report, clinical study protocol, or specific sections within a more comprehensive regulatory submission, would be required. The provided 510(k) summary is high-level and focused on equivalence rather than detailed performance data or AI/ML evaluation.

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