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The Intelligent Articulating and Straight Endoscopic Linear Cutters -- Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

The Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads are reusable, articulating and non-articulating, handheld vascular surgical staplers. The devices are supplied non-sterile and must be cleaned and sterilized prior to use. The device creates a linear transection with three staggered rows of titanium staples on each side of the cutting blade.

The provided text is a 510(k) summary for a medical device (surgical stapler) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic AI device submission would. The document focuses on demonstrating substantial equivalence to predicate devices, not on performance metrics of an AI algorithm.

Therefore, I cannot extract the requested information based on the provided text. The document describes a physical surgical stapler with a modified staple pocket design and updated software to operate it. It is not an AI/ML-based diagnostic device.

If you have a document pertaining to an AI/ML medical device, please provide that, and I will be happy to extract the relevant information.

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