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The Port-site Protector may be utilized in conjunction with devices intended for general laparoscopic cannula/trocar procedures.

The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.

This is an FDA premarket notification (510(k)) for a medical device called the "Port Site Protector". This document is a clearance letter, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical trial report or a performance validation study.

The FDA 510(k) pathway is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials.

Therefore, I cannot provide the requested information based solely on the provided input. The input is a clearance letter, not a scientific study or a detailed technical documentation with performance metrics.

To answer your questions accurately, I would need access to the actual 510(k) submission document (which is usually much more extensive than this clearance letter) or publicly available summaries of its contents, if they exist and include performance data.

Based on the provided clearance letter (K992182) for the "Port Site Protector", I can state the following, but cannot fill in the details regarding acceptance criteria and study particulars because they are not present in this document:

• Device Name: Port Site Protector
• Regulatory Class: II
• Product Code: GCJ
• Regulatory Pathway: 510(k) Premarket Notification
• FDA Determination: Substantially Equivalent to predicate devices. This means the FDA agreed that the device is as safe and effective as a legally marketed device that existed before May 28, 1976, or has been reclassified.

I cannot create the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., because those details are not in the provided clearance letter. These are generally found in the actual 510(k) submission, which would have included performance data or rationale for substantial equivalence.

In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves the device meets them. The letter confirms the FDA's decision but does not detail the evidence presented in the submission.

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