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The Xpan Universal Trocar System is a single use system that is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. The system is indicated for the following uses:

• · Laparoscopic access to the abdominal cavity, both primary and secondary punctures.
• · Thoracoscopic access to the thoracic cavity, both primary and secondary punctures.

The Xpan Universal Trocar System provides a universal port solution wherein the 3mm expandable port is radially expandable from 3mm up to 12mm. Xpan is offered in three sizes and is a single use device. The 5mm and 12mm cannulas are supplied with an optical bladeless tip and include a detachable valve to allow for specimen removal or rapid desufflation. The 3mm expandable trocar can be assembled with the 5mm or 12mm Xpan obturators after tissue insertion or before tissue insertion if desired. The exterior shaft of the 3mm expandable trocar is ribbed to provide security in tissue once inserted in tissue.

The provided text is a 510(k) Premarket Notification for the "Xpan Universal Trocar System." This document is primarily concerned with demonstrating "substantial equivalence" of a new medical device to existing legally marketed devices, rather than establishing acceptance criteria or performing a study to prove a device meets specific performance metrics in the way one might for an AI/ML-based diagnostic device.

The document focuses on:

• Device Description: What the Xpan Universal Trocar System is and its components.
• Intended Use: The medical procedures it's designed for (laparoscopic and thoracoscopic access).
• Performance Data (Nonclinical): Bench testing (e.g., Insertion Force, Retention Force, Insufflation) and biocompatibility, as well as sterilization and shelf life.
• Comparison with Predicate Device: A detailed table comparing the new device's features to those of a predicate device (VersaStep Bladeless Trocar, K012539) and reference devices.

Crucially, the document explicitly states: "No animal studies were performed" and "No clinical studies were performed." This means there is no data presented in this document about:

• Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets in the context of AI/ML.
• Expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC studies or standalone algorithm performance.
• Ground truth types (pathology, outcomes data, expert consensus).

The "performance data" mentioned refers to engineering and material safety tests, not performance in a diagnostic or AI/ML context that would involve metrics like accuracy, sensitivity, or human reader improvement.

Therefore, based on the provided document, it is not possible to answer your questions regarding acceptance criteria and performance study details that relate to AI/ML or diagnostic accuracy, as this submission is for a physical medical device (a surgical trocar) and explicitly states no clinical or animal studies were performed.

The document's purpose is to show that the new trocar is substantially equivalent to existing trocars based on intended use, technological characteristics, and non-clinical bench testing, and that any differences do not raise new questions of safety and effectiveness. It does not involve any AI/ML components or comparative effectiveness studies with human readers.

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