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The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform 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 QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device.
  Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multiinstrument port is comprised of the following three components:
• An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity.
• A retroctor 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 QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.

The provided document describes the acceptance criteria and study for the ASC QuadPort+ Laparoscopic Access Device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as a number of subjects. The study involved a "porcine model," implying animal subjects.
• Data Provenance: The study was conducted on a "porcine model," which suggests an experimental, prospective study in a controlled animal setting. The country of origin is not specified but is likely the location of Advanced Surgical Concepts (Ireland) or a contracted research facility.

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

• Number of Experts: Not explicitly stated as a specific number. The document mentions "clinicians who were experienced with single port devices."
• Qualifications of Experts: They were "experienced with single port devices." Specific qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The criteria are reported as direct observations (e.g., "The device was easy to insert"), implying a consensus or direct observation by the participating clinicians rather than a secondary adjudication process.

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

• No, an MRMC comparative effectiveness study was not done. This device is a laparoscopic access device, not an AI-powered diagnostic tool. The performance study evaluated its functional aspects in a surgical setting.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not an algorithm. The performance was evaluated with clinicians using the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: The ground truth was established through expert observation and assessment during a simulated surgical procedure in a porcine model. The clinicians directly observed and evaluated the device's functional performance against predefined criteria.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not provided. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The "design inputs" and "design verification testing" serve a similar purpose to initial development and validation, but not in the context of a "training set" for AI.

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

• How Ground Truth for Training Set Was Established: Not applicable/not provided for the reasons stated above. The "ground truth" for the device's design and manufacturing (analogous to training for an algorithm) would be established through engineering specifications, material testing, and internal design verification processes against known quality and safety standards, but not in the sense of labeled data for AI.

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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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