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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."

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

The document does not specify sample sizes for these performance tests. The data provenance is also not explicitly stated in terms of country of origin or retrospective/prospective. These are bench performance tests conducted by the manufacturer, Taiwan Surgical Corporation (located in Taiwan).

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. These are physical performance tests of a medical device, not an AI/ML algorithm requiring expert-established ground truth.

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

Not applicable. This concept is for diagnostic performance evaluation of an AI/ML algorithm.

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 a physical medical device, not an AI/ML algorithm for image interpretation.

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)

Not applicable. The "ground truth" for these performance tests are objective measurements of physical properties (e.g., force, pressure, durability) using standardized testing methods.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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