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The WallFlex Biliary PLUS RX Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.

The WallFlex™ Biliary PLUS RX Stent System is an implantable biliary self-explaining metal stent that is pre-loaded onto a Delivery System with a working length of 194cm, which allows delivery of the stent into the Biliary system endoscopically. The self-expanding metal stent consists of Platinum cored Nitinol wires wound together to form a cylinder including flares on both the hilar and duodenal ends. WallFlex™ Biliary PLUS RX Stent is available fully covered with a Permalume™ covering.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets these criteria. The document is an FDA 510(k) clearance letter for a medical device (WallFlex Biliary PLUS RX Stent System) and its accompanying 510(k) summary.

While it mentions that "Performance testing for the proposed WallFlex™ Biliary PLUS RX Stent System was completed in accordance with the following FDA Guidance documents to support substantial equivalence," it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for any test set (it mentions non-clinical tests, not a clinical trial or AI model validation).
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Stand-alone (algorithm only) performance studies.
• Type of ground truth used or how it was established.
• Training set details (sample size or ground truth establishment).

The document is primarily a regulatory communication confirming substantial equivalence to predicate devices based on non-clinical performance data and design comparisons, not a detailed report of a clinical efficacy/effectiveness study or performance validation for an AI/CADe device.

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