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The DuraMax™.018 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree

The DuraMax™.018 Biliary Stent Delivery System is a balloon- expandable 316L stainless steel stent pre-mounted on a delivery catheter. The delivery catheter is an Over-the-Wire (OTW) design with a distal balloon and two radiopaque markers to aid in the placement of the stent. The proximal end of the catheter has a Y-connector that allows for the use of a guidewire ≤0.018" and the attachment of a balloon inflation device via a standard luer connector. Stents sizes include diameters of 5, 6 & 7 mm in lengths of 13, and 18 mm. The catheter is available in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103 cm are provided on the 135 cm catheter. The catheter system is provided sterile and is intended for one use only.

The DuraMax™ .018 Biliary Stent System has achieved substantial equivalence based on a comparison to a predicate device and extensive non-clinical testing. Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sized Used for the Test Set and the Data Provenance

The provided document does not mention any human clinical study or "test set" in the context of a comparative effectiveness study with human subjects. The safety and effectiveness were demonstrated using "non-clinical design verification tests and analyses" and "bench and Biocompatibility testing." Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this case.

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

This information is not applicable as the document does not describe a study involving human experts establishing ground truth for a test set. The evaluation was based on non-clinical testing and comparison to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a study involving human experts and adjudication for a test set.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers improving with AI in the provided documents. The DuraMax™ .018 Biliary Stent System appears to be a medical device (stent and delivery system), not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the DuraMax™ .018 Biliary Stent System is a physical medical device, not an algorithm, and its performance would not be evaluated in a "standalone" algorithmic context.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established through:

• Non-clinical design verification tests and analyses (Bench testing): This refers to laboratory testing to evaluate the device's physical properties, mechanical performance, and functional characteristics against predetermined specifications.
• Biocompatibility testing: This confirms that the materials used in the device are safe for contact with the human body and do not elicit adverse biological responses.
• Comparison to a predicate device: The device's characteristics and intended use were deemed "substantially equivalent" to the Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM .018" Delivery System, implying that the predicate's established safe and effective performance serves as a benchmark for the DuraMax system.

8. The Sample Size for the Training Set

This information is not applicable. The DuraMax™ .018 Biliary Stent System is a physical medical device, not a machine learning model, and therefore did not undergo "training" with a dataset in that sense. The "training" in this context would likely refer to the design, engineering, and manufacturing processes that led to the device's creation.

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

This information is not applicable for the same reasons as #8. The "ground truth" for the device's design and manufacturing would be established through engineering principles, material science, and quality control processes to ensure it meets its specifications.

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