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The SurgASSIST® Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

The SurgASSIST® Circular Stapler Digital Loading Units® (DLUs) offer computer mediated steering and stapling. The DLUs contain implantable, titanium staples and integral cutting blades. The DLUs are used to anastomose tubular structures by applying a double staggered circular row of staples through the tissue. The staples form to controlled closed conditions to secure the layers of tissue together. The DLUs also cut away the excess tissue at a controlled diameter inside the ring of staples. The Circular Stapler DLUs are available in the following four sizes: 21 mm, 25 mm, 29 mm, and 33 mm. The DLU is supplied sterile and ready for use upon removal from its packaging. The purpose of this submission is to clear the modifications to the 29 mm Circular Stapler DLU only.

The provided text describes a Special 510(k) submission for modifications to a medical device, the SurgASSIST® Circular Stapler Digital Loading Units® - 29 mm. It focuses on the device's design changes to address a previous recall issue related to latching mechanism failure. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions regarding study design. The text primarily focuses on regulatory approval for design modifications rather than reporting on a new performance study to meet specific metrics.

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