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The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé® EverFlex™ Self-Expanding Biliary Stent System is intended for palliation of malignant strictures 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 text is a 510(k) Premarket Notification summary for the Protégé® EverFlex™ Self-Expanding Biliary Stent System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a detailed study proving the device meets them.

Instead, the key takeaway from the provided text is:

• Acceptance Criteria and Device Performance: The document states that "Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé® EverFlex™ Self-Expanding Biliary Stent System meets the requirements that are considered acceptable for the intended use." However, specific numerical acceptance criteria and the reported device performance against those criteria are not provided.
• Study Type: The study conducted was primarily bench testing to support a claim of "substantial equivalence" to a predicate device, rather than a clinical study evaluating specific performance metrics against pre-defined acceptance criteria.
• No Information on:
  • Sample size for the test set or data provenance
  • Number or qualifications of experts for ground truth establishment
  • Adjudication method
  • Multi-reader multi-case (MRMC) comparative effectiveness study
  • Standalone algorithm performance (this is not an AI device)
  • Type of ground truth
  • Sample size for the training set
  • How ground truth for the training set was established

In summary, the provided submission is a 510(k) for a medical device (biliary stent) that relies on demonstrating substantial equivalence through bench testing. It does not include the detailed clinical study information and acceptance criteria that would typically be found for a novel device or an AI/software as a medical device (SaMD) where performance metrics against a defined ground truth are central to acceptance.

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