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The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Stapler has application in the resection of tissue for abdominal. gynecological, pediatric and thoracic surgical procedures.

The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance and biliary structures.

The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.

The Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids.

The Disposable Linear Stapler places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 90mm staple line length for use in various applications. Two staple sizes (3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.

Disposable Circular stapler place 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. It is available in 20, 22, 24, 26, 29, 32mm six specifications. Two staple sizes (4.7mm and 5.6mm) are available to accommodate various tissue thicknesses.

Disposable Endoscopic Linear Cutter Stapler and Cartridge places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.

Disposable Linear Cutter Stapler Cartridge places a two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.5mm. It may be reloaded and fired up to 5 times for a total 6 firings in a single procedure.

Disposable Circular Stapler for Hemorrhoids 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 device is available in 34mm with 4.6mm staple.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance in the format you specified.

The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed study proving the device meets specific acceptance criteria in the way you've outlined.

Here's what the document does provide and why it doesn't fit your request:

• Non-Clinical Test Conclusion: It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It lists several ISO and ASTM standards that the device complies with, in areas such as biological evaluation, sterilization residuals, irritation/hypersensitivity, bacterial endotoxins, and seal strength of packaging.
• No Clinical Study: It explicitly states, "No clinical study is included in this submission."
• Comparison Tables (Tables 1-5): These tables compare the proposed devices (various staplers) with predicate devices on technical characteristics like product code, regulation number, intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization method, endotoxin limit, and labeling. This comparison is to establish "substantial equivalence," not to detail acceptance criteria and performance against those criteria as a standalone study.

Therefore, I cannot extract:

1. A table of specific acceptance criteria and reported device performance. The document only mentions compliance with standards.
2. Sample size, data provenance, number of experts for ground truth, adjudication method, or ground truth type for a test set of a performance study.
3. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance.
4. Sample size and ground truth establishment for a training set.

The document's purpose is to demonstrate that the new devices are as safe and effective as already marketed devices, primarily through comparison of technical characteristics and adherence to general performance standards, rather than presenting a novel performance study against defined acceptance criteria.

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