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The Zilver 518 and 635 Biliary Stent are indicated for use in palliation of malignant neoplasms in the billary tree.

The Zilver® 518 and 635101 Biliary Stent is a self-expandable stent made of nitinol. The special laser-cut pattern of the nitinol tube provides a construction with strong radial force and high flexibility. It is a slotted tube that is designed to provide support while maintaining flexibility in the duct upon deployment. Post-deployment, the stent is designed to impart an outward radial force upon the inner lumen of the duct, establishing patency in the stented region, thereby maintaining constant flow in the duct. The stent has radiopaque markers (gold rivets) at both ends to assist in fluoroscopic visualization of the stent position. The delivery system for both ZIB5 and ZIB6 devices includes a handle assembly and an introducer catheter assembly. The Zilver® 518 and 635™ Biliary Stent is mounted on the inner catheter of the delivery system and is restrained by an outer sheath. The delivery system is used to deliver the stent to the appropriate location. The stent is deployed by retracting the outer sheath while holding the central metal cannula stationary. Full deployment of the stent occurs when the distal end of the sheath has been retracted past the proximal end of the stent.

The provided text is a 510(k) summary for the Zilver® 518 and 635TM Biliary Stent. It describes the device, its intended use, comparison to predicate devices, and performance data. However, it does not contain explicit "acceptance criteria" or a detailed "study that proves the device meets the acceptance criteria" in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC, human reader studies).

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through:

1. Technological Characteristics Comparison: Showing the new device is identical or within the range of the predicate, with minor changes like material formulation modification, change from MR Safe to MR conditional, and consolidation of Instructions for Use.
2. Performance Data: This section details non-clinical testing for biocompatibility and MRI compatibility. It does not include clinical performance metrics, accuracy, or diagnostic effectiveness against a ground truth.

Therefore, many of the requested items in your prompt are not applicable or cannot be extracted from this specific document, as it pertains to a traditional medical device (biliary stent) and its 510(k) clearance process, not an AI/ML device.

Here's an attempt to answer your questions based solely on the provided text, noting where information is absent:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate devices and by meeting relevant biocompatibility and MRI safety standards. There are no performance metrics like sensitivity, specificity, F1-score, or similar clinical effectiveness measures reported for this device's function as a stent in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The reported studies are non-clinical (biocompatibility, MRI safety, mechanical testing on samples of the device itself) and do not involve patient data or test sets in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical medical device (stent), and its evaluation did not involve establishing ground truth from experts for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device and evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The performance data for this device focuses on physical properties, biocompatibility, and MRI compatibility rather than diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

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