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The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions:

• Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
• Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device.

The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components:

• An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity.
• A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments.
• A valve component which maintains the pneumoperitoneum established for the surgical . procedure.

The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows:

• 1. Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration.
• 2. The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient.

The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device.

The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.

The provided text is a 510(k) summary for the ASC TriPort 15 Laparoscopic Access Device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert reviews in terms of clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information, which is typical for a study validating the diagnostic accuracy or clinical effectiveness of a device, is not present in the provided text.

Specifically, the document states:
"Sterilization and shelf life testing, biocompatibility testing, design validation testing, and animal testing of the TriPort 15 was conducted to verify that the changes to the technological characteristics do not affect safety or effectiveness. In all instances, the TriPort 15 functioned as intended."
And:
"Performance data demonstrate that the TriPort 15 is as safe and effective as the predicate device."

This indicates that the "acceptance criteria" were related to verifying safety and effectiveness through non-clinical performance testing (sterilization, shelf life, biocompatibility, design validation, animal testing) to ensure the minor changes from the predicate device did not introduce new safety concerns or alter its intended function.

Since this is a submission for a laparoscopic access device (a surgical tool, not a diagnostic or AI-driven device), the nature of the "acceptance criteria" is fundamentally different from a diagnostic device that would involve human reader performance, ground truth establishment by experts, and statistical metrics like sensitivity and specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format requested (which implies clinical performance metrics), nor details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/diagnostic device.

The study described is an engineering validation and non-clinical performance study to demonstrate that the modified device (TriPort 15) is as safe and effective as its predicate (TriPort+), primarily through bench testing and animal studies, not through clinical trials involving human subjects or expert interpretations of images.

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