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The Protégé® GPSTM Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.

The provided document pertains to a 510(k) premarket notification for a medical device, specifically a biliary stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials that establish specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain the requested information regarding acceptance criteria, the study proving the device meets those criteria, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance.

Instead, the submission focuses on demonstrating:

• Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
• Device Description: Self-expanding nitinol stent with an open lattice design, electropolished, premounted on a delivery catheter.
• Modification: Addition of 150mm length stents in 6, 7, and 8mm diameters to the existing 6Fr 0.035'' delivery system.
• Substantial Equivalence: Claim that the modified device is substantially equivalent to a currently marketed stent and delivery system in intended use, materials, technological characteristics, and performance.
• Evidence for Equivalence: Performance testing (bench testing) supported the substantial equivalence claim.

The FDA's review confirms this substantial equivalence based on the provided information, but also imposes a specific warning and labeling requirements to mitigate potential off-label use in the vascular system.

In summary, the provided text describes a regulatory submission for a medical device based on substantial equivalence, not a study setting specific acceptance criteria and demonstrating human or AI performance against them.

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