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Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

The proposed Advanix™ Biliary Stent with NaviFlex™ RX Delivery System consists of biliary plastic stents and delivery system catheters. They are sold separately or in a pre-loaded configuration, in which a stent comes attached to the catheter via a suture. The system is comprised of two (2) primary components: stent and delivery catheter with a locking mechanism. The Advanix Biliary Stent allows for drainage of the biliary duct and gall bladder by preventing closure and maintaining the patency of the biliary duct. These biliary stents are provided in center bend and duodenal bend shapes and have leading and trailing bars, a tapered leading end tip to facilitate access through the papilla, and a rounded tailing end to match the profile of the push catheter portion of the delivery system.

The Advanix Biliary Stent will be offered in 7Fr. 8.5Fr, and 10Fr diameters. The stent leneths for each diameter vary from 5cm-18cm stent lengths. The Advanix biliary stents are constructed of a Polyethylene material.

The NaviFlex RX Delivery System will be offered in 202.5cm working length. The delivery system consists of a guide catheter and outer push catheter. The guide catheter is constructed of Polyvinylidene fluoride material. The guide catheter also includes a radiopaque marker. The push catheter is composed of polyether block amide material and also has a Nylon repositioning suture.

The provided text describes the regulatory clearance for a medical device, specifically the Advanix™ Biliary Stent with NaviFlex™ RX Delivery System. It functions as a 510(k) Summary, outlining the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

However, the information provided does not contain the details typically found in a study report designed to "prove the device meets acceptance criteria" in terms of clinical performance or a detailed analytical study with statistical analysis. Instead, it focuses on bench testing and biocompatibility to demonstrate safety and performance similar to an already cleared device.

Therefore, for many of the requested categories, the answer will be "Not Applicable" or "Not specified in this document" because the document is a 510(k) summary, not a clinical study report.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes a series of tests performed, implying that for each test, there were "required specifications" that were met. However, the specific numerical acceptance criteria and the quantitative reported performance for each criterion are not detailed in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in this 510(k) summary. The document mentions "in-vitro testing" and "all components, subassemblies, and/or full devices" but does not give a specific number of units tested for each criterion.
• Data Provenance: The tests are described as "in-vitro testing" and "bench tests," implying laboratory-based testing, not human patient data. There is no mention of country of origin for data or whether it was retrospective or prospective, as these are typically clinical study terms.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This document describes engineering and biocompatibility testing, not a study where human experts would establish a "ground truth" for a test set (e.g., image interpretation). The "ground truth" for these tests would be the established engineering specifications and recognized biocompatibility standards.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical or image-based studies where expert consensus is needed to resolve discrepancies. This document describes laboratory testing against predetermined specifications.

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 document does not describe a multi-reader multi-case study, clinical trial, or any assessment of AI assistance. The device is a physical medical implant (stent) and a delivery system.

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

• Not Applicable. This device is a physical stent and delivery system, not an algorithm or AI.

7. The type of ground truth used

• The "ground truth" for the tests described would be based on engineering specifications (for device bench testing) and established international standards (EN ISO 10993-1:2009 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" explicitly mentioned as ground truth for the evaluations detailed in this summary.

8. The sample size for the training set

• Not Applicable. This document does not describe a machine learning algorithm or AI model that would require a "training set." The performance assessments are for a physical medical device.

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

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