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The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent System) to an obstruction site in the biliary tree where the balloon is then inflated to expand the stent. After full expansion of the stent, the balloon is then deflated and subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The provided 510(k) summary (K040413) for the Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System details its safety and effectiveness through substantial equivalence to predicate devices, rather than through presenting acceptance criteria and a study demonstrating the device meets those criteria.

Therefore, the requested information elements related to specific acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert reviews, and comparative effectiveness studies are not contained within the provided document.

The document focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices.

Here's a breakdown of what is available regarding safety and effectiveness, based on the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available. The document does not specify quantitative acceptance criteria or report specific device performance metrics in numerical form. It relies on demonstrating substantial equivalence to predicate devices.

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

• Not available. The document states that safety and effectiveness were demonstrated via "non-clinical in-vitro and animal testing (stent placement in biliary duct)". It does not provide sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective) beyond stating it was non-clinical.

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

• Not available. Ground truth establishment by experts for a test set is not described, as the evaluation was non-clinical.

4. Adjudication method for the test set:

• Not available. Adjudication methods are not applicable to the non-clinical testing described.

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 device is a transhepatic biliary stent system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.

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

• Not applicable. See point 5.

7. The type of ground truth used:

• Implied non-clinical data: The document refers to "non-clinical in-vitro and animal testing (stent placement in biliary duct)". The "ground truth" here would likely be derived from measurements, observations, and histological findings from these non-clinical tests demonstrating stent function, patency, and biocompatibility in the animal model. It is not an expert consensus, pathology, or outcomes data from human patients.

8. The sample size for the training set:

• Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not applicable. See point 8.

Summary of Studies (from the document):

The document explicitly states:

• "The safety and effectiveness of the device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998."
• "The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded biocompatible."

The 510(k) submission relies on demonstrating substantial equivalence to already cleared predicate devices, citing similarities in:

• Intended use
• Components
• Dimensions (size range)
• Accessories
• Method of delivery
• Fundamental technology (operating principle)
• Packaging configuration and materials
• Manufacturing and sterilization processes
• Stent material (Cobalt Chromium-alloy, comparing to components in knee implants)

This approach is common for medical devices where a new device is similar enough to an existing one that extensive new clinical trials are not required for market clearance.

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