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The Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical EndoWrist Stapler 45 System when used with the compatible Stapler 45 Reloads delivers multiple rows of staples and transects the tissue along the middle of the staple line. The EndoWrist Stapler 45 System is a reusable device and the Stapler 45 Reloads (available in various sizes) are single-use/disposable devices.

The provided document is a 510(k) summary for the Intuitive Surgical EndoWrist® Stapler 45 System and Stapler 45 Reloads, a surgical stapler. It describes the device, its intended use, and states that performance data (bench and animal tests) demonstrate substantial equivalence to a predicate device. However, it does not contain the specific details required to answer the questions about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth methods.

The document states: "Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." This statement indicates that studies were performed, but the specifics of those studies are not included in this summary.

Therefore, I cannot provide the requested information from the given text.

Here's what the document does tell us, and why the other information is missing:

• Acceptance Criteria & Reported Performance: The document only states that "design output meets the design input requirements" and that the device is "substantially equivalent" to the predicate. It does not provide a table of specific acceptance criteria or detailed performance metrics.
• Sample Size (Test Set) & Data Provenance: Not mentioned. The studies are referred to generally as "bench and animal tests."
• Number of Experts & Qualifications: Not applicable for bench/animal tests of a surgical stapler's mechanical performance.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable to a surgical stapler's performance. This type of study is typically for evaluating diagnostic imaging or AI systems where human reader performance is a key metric.
• Standalone Performance: The performance data would inherently be "standalone" for the device itself, but specific metrics are not provided.
• Type of Ground Truth: For a surgical stapler, "ground truth" would likely involve objective measurements of staple formation, tissue integrity, leak pressure, etc., established during bench and animal testing. However, the exact methods are not detailed.
• Sample Size (Training Set): Not applicable for this type of device. "Training set" refers to data used to train AI/machine learning models, which is not relevant here.
• How Ground Truth for Training Set was Established: Not applicable.

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