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The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)

The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery and evacuate surgical smoke. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.

This 510(k) submission does not describe a study involving an AI/ML device, but rather a medical device (trocar and cannula system). Therefore, some of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not applicable in this context.

Here's an analysis of the provided text in relation to your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions various tests but largely defines them by their purpose rather than explicit quantitative acceptance criteria with corresponding performance metrics. It indicates adherence to standards as the form of "acceptance."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as this is a physical medical device, not an AI/ML system tested on a dataset. The "tests" described are functional and safety verification tests. The document does not specify the number of units tested for functional performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth as typically defined for AI/ML does not apply here. Performance for a physical device is assessed through engineering tests and adherence to standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable.

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 is not an AI/ML device or an imaging device requiring human interpretation, so an MRMC study is irrelevant.

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

Not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the functional aspects, "ground truth" would be established by direct measurement of physical parameters (e.g., CO2 pressure for pneumoperitoneum, smoke particle reduction for evacuation) against predefined engineering specifications. For safety and sterility, it's compliance with established international standards (IEC, ISO, AAMI).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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