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The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

The Express® SD Biliary Monorail® Premounted Stent System (Express SD Biliary) is a traditional Monorail catheter with a balloon near the distal tip. Express SD Biliary consists of a delivery system and a stent that is balloon expandable intended to maintain patency of biliary strictures produced by malignant neoplasms.

This document is a 510(k) summary for the Express® SD Biliary Monorail® Premounted Stent System. It's a premarket notification to the FDA to demonstrate substantial equivalence to an already marketed device, not a study proving the device meets acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this type of document.

This 510(k) pertains to a medical device (a stent system), not an AI/ML powered device. The "study" mentioned here refers to non-clinical tests (first article, shaft, and bond burst testing) to ensure the physical properties of the device (specifically a modified corewire) are equivalent to the predicate device, not clinical performance studies against specific acceptance criteria for a diagnostic or prognostic claim.

Here's why some of the requested information cannot be found:

• Acceptance Criteria & Device Performance Table: This document discusses substantial equivalence to a predicate device based on similar design, materials, and non-clinical testing. It does not provide specific performance metrics or acceptance criteria in the way an AI/ML device submission would (e.g., sensitivity, specificity thresholds).
• Sample Size (Test Set) & Data Provenance: Non-clinical testing of physical components doesn't typically involve "test sets" of patient data or data provenance in the context of clinical AI/ML studies.
• Number of Experts & Qualifications / Adjudication: This is relevant for establishing ground truth in clinical studies, particularly for imaging or diagnostic AI. It's not part of a non-clinical device equivalence assessment.
• MRMC Study / Standalone Performance: These are specific to AI/ML powered diagnostic or screening devices to assess their impact on human readers or their performance without human intervention. This device is a physical stent system.
• Type of Ground Truth: Ground truth (e.g., pathology, clinical outcomes) is established in clinical studies for diagnostic or prognostic purposes. The "ground truth" for this device is its physical integrity and performance as determined by engineering tests (e.g., burst pressure, stiffness).
• Sample Size (Training Set) & Ground Truth for Training Set: These concepts are specific to the development and validation of AI/ML models. This document describes a physical medical device.

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