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The Disposable Circular Stapler has application throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses.

The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.

The provided 510(k) summary (K100723) describes the Changzhou Kangdi Medical Stapler Co., Ltd. Disposable Circular Stapler. However, it does not contain information related to acceptance criteria or a study proving that an AI-driven device meets such criteria.

The document describes a medical device, a surgical stapler, and its equivalence to a predicate device. The performance testing section focuses on biocompatibility, general device performance standards (for implanted titanium), and package integrity/shelf-life assessments. These are all related to the physical and functional aspects of the hardware device, not an AI or software component.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI-related effectiveness studies, as these details are not present in the given text.

In summary, the provided text describes a traditional hardware medical device and its predicate equivalence, not an AI-driven device.

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