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The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatic use. The device can be used with staple line or tissue buttressing material.

The Intuitive Surgical IS4000 EndoWrist® Stapler 30 and Stapler 30 Reloads is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS4000). It is intended for resection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip. The Stapler 30 Reloads consist of a single use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The reloads are available in four configurations (Gray, White, Blue and Green) to accommodate tissues of various thicknesses (e.g., lung, stomach, and bowel).

The provided text describes a 510(k) premarket notification for a surgical stapler device (IS4000 EndoWrist Stapler 30 and Reloads) and extensively details performance data, including bench and animal testing. However, it does not contain any information about an AI/algorithm-driven device or studies related to AI performance, human-in-the-loop performance, or any of the specific criteria typically used for AI-based medical device evaluations (e.g., sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or adjudication methods).

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets those criteria for an AI-based device using the provided text. The document is for a mechanical surgical stapler.

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