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The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.

The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.

This document describes a medical device, the "Family of Balloon Cannula," and compares it to a similar device, the "Hasson Stabilizing Access Cannula (SACun)," to demonstrate substantial equivalency. However, the provided text does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.

The document focuses on:

• Intended Use and Indications: Describing what the device is for and how it functions.
• Substantial Equivalency: Directly comparing its materials, sizes, functions, and sterilization methods to a predicate device.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth establishment. This information is simply not present in the provided text.

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