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The ADAPt™ Universal Laparoscopic Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

The ADAPt™ Universal Laparoscopic Port consists of an obturator and cannula set which will accommodate instruments in the 5-10mm range with a cannula length of 100mm and the 5-10-12mm range with cannula lengths of 100mm and 125mm. The device utilizes a set of three seals. The first seal is the Floating Top Seal which accommodates instruments ranging from 10mm to 12mm. The second seal is the Floating Caged Seal which accommodates instruments in the 5mm range. The third seal is the Duck Bill Seal used to maintain insufflation, if no instruments are placed in the port during surgery.

The ADAPt™ Universal Laparoscopic Port is considered substantially equivalent to its predicate device (The ADAPT™ Laparoscopic Port and Accessory, K010007). The evaluation of this device is based on determining its substantial equivalence to the predicate device rather than fulfilling specific, independent acceptance criteria.

Here's a breakdown of the information based on your request, understanding that the context is substantial equivalence for a medical device rather than a diagnostic AI system:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence determination for a medical device (a surgical trocar), the "acceptance criteria" are not reported as quantitative performance metrics in the same way they would be for an AI diagnostic algorithm. Instead, the acceptance is based on demonstrating that the device performs as intended and is equivalent to a predicate device, thereby not raising new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

The document states that "bench testing has been performed." However, it does not specify the sample size for this bench testing or the provenance of any data used (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The study relies on bench testing comparisons to a predicate device, not on expert-adjudicated ground truth as would be typical for a diagnostic AI.

4. Adjudication method for the test set

This information is not applicable and not provided. The evaluation is based on bench testing of the device's physical and functional characteristics.

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 such study was done. This is a medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No such study was done. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the performance and safety established for the predicate device (K010007) and the bench testing results demonstrating that the modified ADAPt™ Universal Laparoscopic Port performs equivalently and safely. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for an AI diagnostic.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that requires a "training set."

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

Not applicable.

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