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The Inno-Port Disposable Bladeless Trocars are in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry.

The Inno-Port Disposable Optical Trocars are intended for use in a variety of gynecologic, general thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

The Inno-Port Disposable Bladeless Trocar and Inno-Port Disposable Optical Trocar are surgical trocars available in 5 mm, 5-11 mm, and 5-12 mm series. They consist of an obturator and a cannula with a self-adjusting seal and stopcock valve. The optical trocar obturator also contains a scope retention mechanism. The seal system accommodates instruments ranging from 5mm to 12mm in diameter depending on the trocar size.

The provided document is a 510(k) summary for the "Inno-Port Disposable Bladeless Trocar" and "Inno-Port Disposable Optical Trocar." It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format requested for AI/ML performance.

Therefore, many of the requested details about acceptance criteria for AI/ML performance, sample sizes, expert qualifications, ground truth, and MRMC studies are not applicable or extractable from this document as it pertains to a medical device's physical performance, not an AI/ML algorithm.

However, I can extract the acceptance criteria and reported device performance for the physical device characteristics as presented.

Here's the information that can be extracted or inferred from the provided text:

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

The document provides a comparison of performance criteria between the proposed device and its predicate devices. The "reported device performance" is essentially that the proposed devices met these criteria, as stated in the conclusion: "The test results showed that both proposed devices have the similar device performance compared to the predicate device."

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