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Passport® Trocars are indicated for use as access devices that create and maintain a passageway for laparoscopic instruments during a variety of laparoscopic procedures, such as general, gynecologic, thoracic, and urological procedures, in adult and adolescent (12 to 21 years of age) populations.

The Passport® Trocars with pediatric indication and Accessories (herein referred to as 'proposed devices') are a family of single-use devices that serve as an access port for laparoscopic instruments during laparoscopic surgery. The two accessory devices included in the submission are the Robotic Reducer Cap and Stopcock with Rotating Male Luer. These devices are to be used with the Passport® Trocars previously cleared in K080161 (herein referred to as 'predicate devices'). The Robotic Reducer Cap can be attached to the 8.5 mm and 12 mm robotic Passport® Trocars to reduce the seal size to accommodate smaller instruments. The Stopcock with Rotating Male Luer can be attached to 3 and 5 mm Passport® Trocars that do not have built-in stopcocks in order to control flow of CO2. The proposed devices are sterilized by ethylene oxide.

This document describes the 510(k) submission for Stryker Endoscopy's "Passport® Trocars and Accessories" (K130826). The submission focuses on expanding the pediatric indication for the existing Passport® Trocars and introducing two new accessory devices: the Robotic Reducer Cap and the Stopcock with Rotating Male Luer.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria or detailed device performance metrics in a readily quantifiable format for the Passport® Trocars and Accessories.

Instead, it broadly states:

In summary, the specific quantitative acceptance criteria and their corresponding results are not provided in this excerpt. The document relies on general statements about meeting "design specifications," "applicable performance standards," and compliance with ISO standards.

The remaining questions delve into specific study details that are not present in the provided text. The document is a 510(k) summary, which typically provides a high-level overview rather than detailed study protocols or results.

Here's what cannot be answered from the provided text:

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

• Not mentioned. The document only states that "bench performance testing" was performed for the accessories. It does not provide details on sample sizes for these tests, nor does it refer to any clinical "test set" in the context of human or animal 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/Not mentioned. This information is typically relevant for studies involving human interpretation or subjective assessment (e.g., medical imaging devices evaluating disease presence). The device in question is a surgical tool and accessories, and the performance testing mentioned is "bench performance testing," which would not involve experts establishing "ground truth" in this manner.

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

• Not applicable/Not mentioned. Similar to point 3, adjudication methods are for resolving discrepancies in human interpretation, which is not described as part of the performance testing for this 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. This device is a surgical instrument and accessories, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI assistance is not relevant or described.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable/Not mentioned for a clinical context. For the bench testing of accessories, the "ground truth" would be related to engineering specifications and measurements (e.g., force, flow rate, seal integrity). The document does not provide details on these specific measurements or the "ground truth" against which they were compared, other than generally stating compliance with "design specifications and applicable performance standards."

8. The sample size for the training set

• Not applicable. This device does not involve an AI algorithm, and therefore there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

Conclusion based on provided text:

The submission for the Passport® Trocars and Accessories relies on:

• Substantial equivalence to a predicate device (K080161) for the main trocar component, especially for the pediatric indication expansion, indicating that no new performance data was generated for the trocars themselves for this part of the submission.
• Bench performance testing for the new accessories, ensuring they meet "design specifications" and "applicable performance standards."
• Compliance with ISO standards for biocompatibility (ISO 10993-1) and sterilization (ISO 11135-1).

The document is a high-level summary and does not contain the detailed quantitative acceptance criteria or granular study data typically found in a full study report. It focuses on establishing that the device "raises no new questions of safety and effectiveness" due to its similarity to predicate devices and adherence to general performance and safety standards.

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