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The Cordis PALMAZ® XL Transhepatic Biliary Stents are intended for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ® XL Transhepatic Biliary Stent is a balloon-expandable, laser cut stent made from 316L stainless steel tubing. The stent is supplied in two nominal lengths: 40 mm, and 50 mm. The stent is designed to expand to 10mm diameter. The PALMAZ® XL Transhepatic Biliary Stent is sold unmounted for use with the Cordis POWERFLEX™ PLUS Percutaneous Transluminal Angioplasty (PTA) balloon catheter.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence. The document is a 510(k) submission summary for the Cordis PALMAZ® XL Transhepatic Biliary Stent, focusing on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of the information available based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria. Instead, it asserts "substantial equivalence" to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "pre-clinical testing" for confirming substantial equivalence, but details on the number of devices or scenarios tested are absent.
• Data Provenance: Not specified (e.g., country of origin). The testing is described as "pre-clinical," which typically implies laboratory or animal studies, not human clinical data in this context. The document does not indicate if it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. The document describes pre-clinical testing for substantial equivalence, which would likely involve engineering and material scientists, rather than medical experts establishing ground truth in a clinical trial setting.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication process for a test set in the context of expert review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not mentioned in the document. The focus is on demonstrating substantial equivalence through pre-clinical testing, not on comparing human reader performance with and without AI assistance. The device itself is a physical stent, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The device is a physical medical device (biliary stent), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used for diagnostic devices (e.g., pathology, outcomes data) is not explicitly detailed here. For pre-clinical testing of a physical device like a stent, "ground truth" would relate to engineering specifications, material properties, mechanical performance (e.g., expansion, radial strength, fatigue resistance), and biocompatibility, likely established through laboratory measurements and established testing methodologies. The document states "All materials used... are biocompatible," which would imply testing against established biocompatibility standards.

8. Sample Size for the Training Set:

Not applicable. Since this is a physical medical device and not an AI/ML algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

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