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The Innovia InnoPort™ Laparoscopic Access Port is a sterile, single use device, intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.

The InnoPort™ Laparoscopic Access Port is a sterile, single use laparoscopic access device made of a flexible Quatromer polymer combined with polycarbonate and polyurethane components. It forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the insufflation system to provide intra-abdominal pneumoperitoneum. The instrument ports are designed to accommodate 5 mm diameter laparoscopic instruments while allowing full maneuverability without loss of pneumoperitoneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.

I am designed to extract and analyze information related to medical device acceptance criteria and performance studies. However, the provided document (K090677) describes a Laparoscopic Access Port, which is a physical surgical device, not a software-based AI device.

Therefore, the concepts of "acceptance criteria for an AI device," "device performance in a study proving AI acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "training set size," and "ground truth for training set" are not applicable to this document.

The document discusses performance and functional testing for the physical laparoscopic device, including bench and in vivo tests to verify its ability to:

• Maintain pneumoperitoneum with minimal leakage.
• Allow introduction and manipulation of instruments.
• Meet performance specifications.

It concludes that the device is "substantially equivalent" to its predicate device and introduces "no new safety or effectiveness issues." This is the standard for 510(k) clearances for physical devices, focusing on safety and equivalence rather than AI-specific performance metrics.

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