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The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.

Disposable Endoscopic Cutter Stapler and Cartridge place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths with cartridge in 2.0/2.5/3.0, 3.0/3.5/4.0, 4.0/4.5/5.0 three progressive staple sizes to accommodate carious tissue thickness. The device may be reloaded and fired up to 12 times in a single procedure.

The provided document is a 510(k) summary for a medical device (Disposable Endoscopic Cutter Stapler and Cartridge), not a report for an AI/ML-based medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study details, expert involvement, and ground truth for an AI device is NOT present in this document.

The document demonstrates the substantial equivalence of the new stapler to a predicate device through:

• Non-clinical tests: These include biocompatibility testing (ISO 10993 series, USP standards), sterilization validation (ISO 11135), and bench tests on porcine tissue (Pressure Resistance, Closed Staple Height, Staple Formation, Force Required to Fire Stapler).
• Comparison table (Table 1): This table directly compares various characteristics of the proposed device and the predicate device, often stating "SE" (Substantially Equivalent) if they are sufficiently similar or providing a qualitative "SE Analysis" if there are differences.

There is no mention of:

• AI/ML algorithms.
• Data sets for training or testing AI models.
• Human readers, expert consensus, or specific ground truth methodologies for evaluating an AI system.
• MRMC studies or effect sizes for human improvement with AI assistance.

Therefore, I cannot populate the requested table and answer the specific questions related to AI/ML device validation based on this document.

The document specifically states under "7. Clinical Test Conclusion": "No clinical study is included in this submission." This further confirms the absence of the type of information you are seeking regarding device performance in a clinical or reader study context for an AI device.

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