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The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.

The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

The Single Use Hemorrhodial Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.

The Single Patient Use Transverse Cutter and Reload is intended for transection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.

The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.

Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 26mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.

Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in five staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm. 3.5mm. 3.8mm and 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.

Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.

Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.8mm, 4.2mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.

Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.

The provided text is a 510(k) summary for several surgical staplers and does not contain the specific information required to answer the prompt questions regarding acceptance criteria and a study proving device performance against those criteria in the context of an AI-powered diagnostic device.

This document describes surgical staplers, which are physical medical devices, not AI-powered diagnostic devices. The performance tests mentioned (pressure resistance, closed staple height, staple formation, force to fire) are mechanical tests of the staplers themselves, comparing them to predicate devices. There is no mention of "acceptance criteria," "reported device performance" in terms of diagnostic metrics, "sample size for test set," "data provenance," "experts creating ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth" (for diagnosis), "training set size," or "ground truth for training set."

The document concludes that the proposed devices are "Substantially Equivalent (SE) to the predicate devices" based on non-clinical tests (biocompatibility and mechanical performance tests). This is a regulatory finding for a traditional medical device, not a performance evaluation for an AI diagnostic algorithm.

Therefore, I cannot extract the requested information from the provided text.

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