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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA™ PRO .035" Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, laser cut stent made from 316L Stainless Steel tubing. The stent is sold mounted on a Cordis percutaneous transluminal angioplasty (PTA) balloon catheter. The stent is provided in nominal, unexpanded stent lengths from 19 to 79 mm. The stent is designed for expansion to diameters from 8 to 10 mm, depending on the diameter of the associated balloon upon which it is mounted.

The Cordis OPTA PRO PTA balloon catheter, formerly known as the OPTA LP PTA Balloon Catheter, is used as a delivery system for the PALMAZ GENESIS Transhepatic Biliary Stent. The delivery system utilizes an over-the-wire design and is a catheter with a distal DURALYN™ balloon and a proximal Y-connector. Two radiopaque marker bands aid in stent placement. The injectate lumen (marked "THRU") is used to inject contrast medium via hand injection, and to track the catheter over a guide wire. The inflation lumen (marked "BALLOON") is used to inflate and deflate the balloon. The nominal balloon size is printed on the Y-connector.

A metal introducer tube is included in the packaging.

The PALMAZ GENESIS Transhepatic Biliary stent on OPTA PRO .035" Delivery System is provided sterile (via ethylene oxide) and is intended for single use only.

The provided document is a 510(k) Premarket Notification for the "Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA™ PRO .035" Delivery System". This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance through extensive clinical trials. Therefore, the information typically requested for AI/device performance studies (like acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is generally not included or applicable in this context.

Here's an breakdown based on the provided text, addressing your questions to the extent possible given the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) submission for a device like this stent and delivery system, the "acceptance criteria" are typically related to meeting design specifications, demonstrating biocompatibility, sterilization efficacy, and functional integrity through non-clinical bench testing. The primary "performance" is its ability to meet the stated intended use and its substantial equivalence to predicate devices. The document explicitly states "Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act."

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

• Sample Size for Test Set: Not specified. The document states "data collected from non-clinical design verification tests and analyses." This typically refers to bench testing of device components, and the "sample size" would relate to the number of devices or components tested to verify specifications (e.g., stent expansion diameter, balloon integrity, delivery system trackability, etc.). These details are not provided in this summary.
• Data Provenance: The data is from "non-clinical design verification tests and analyses," implying laboratory and engineering testing. No mention of human clinical data or its geographical origin is made.

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

• Not Applicable. This is a medical device 510(k) submission, not an AI performance study requiring expert adjudication for ground truth. Technical specifications and functional tests would be verified against engineering standards and design requirements.

4. Adjudication method for the test set

• Not Applicable. See point 3. Testing would follow standard engineering and quality control procedures, not expert adjudication in the context of diagnostic performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation with AI assistance. This document describes a physical medical device (stent and delivery system) and its mechanical/functional performance, not a diagnostic tool requiring human reader comparison.

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

• Not Applicable. This refers to AI algorithm performance. The device described is a physical medical implant and delivery system, not an algorithm.

7. The type of ground truth used

• For the non-clinical design verification, the "ground truth" would be established by the device's design specifications and engineering requirements (e.g., material properties, dimensional tolerances, force requirements, fluid flow rates, etc.). These are verified through various physical and chemical tests.

8. The sample size for the training set

• Not Applicable. This refers to AI/machine learning. The device described does not involve a "training set" in this context.

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

• Not Applicable. See point 8.

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The PALMAZ CORINTHIAN Transhepatic Biliary Stent is indicated for the palliation of malignant neoplasms in the biliary tree.

Certain sizes of the OPTA LP catheters are indicated for deployment of 6-10 mm diameter x 4-10 cm length PALMAZ CORINTHIAN Transhepatic Biliary Stents. The clinical indications for these stents are described in their Instructions for Use.

Additionally, the OPTA LP catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is a balloonexpandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA LP Balloon Catheters are recommended for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent.

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is mounted upon its recommended balloon catheter delivery device via the use of accessory devices – plastic crimping tubes, which are provided with the packaged stent, and crimping tools, which are provided separately. The stent / balloon catheter assembly is then advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided separately, 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 removed.

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and the OPTA LP Balloon Catheter are provided sterile and are intended for single use only.

The provided text describes a 510(k) submission for the Cordis PALMAZ® CORINTHIAN™ Transhepatic Biliary Stent and OPTA LP Catheter. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a standalone study with defined acceptance criteria and performance metrics for this new device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the new device. The primary "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to predicate devices.
• Reported Device Performance: The document states: "The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and its OPTA LP Balloon Catheter delivery device have been demonstrated via data collected from non-clinical design verification tests and analyses."
  • No specific performance metrics (e.g., success rates, complication rates, longevity) from these tests are provided.
  • The document mentions the stent's physical characteristics: "The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent is provided in a range of nominal, unexpanded lengths from 40 to 100 mm and can be expanded to diameters from 6 to 10 mm." This describes its physical capabilities rather than a performance outcome.

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

• Test Set Sample Size: Not applicable/not stated in the document. The submission relies on "non-clinical design verification tests and analyses" and comparison to predicate devices, not a clinical test set in the traditional sense for evaluating device performance.
• Data Provenance: The data is described as "non-clinical design verification tests and analyses." This typically means laboratory testing, material characterization, and engineering analyses, not retrospective or prospective clinical human data from a specific country of origin.

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

• Not applicable. Since this is a 510(k) submission focused on substantial equivalence and non-clinical testing, there is no mention of experts establishing ground truth for a clinical test set. The FDA regulators are the experts who evaluate the substantial equivalence claim.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study was not done. The submission is for a medical device (stent and catheter), not an AI algorithm, and focuses on substantial equivalence based on physical and functional characteristics, not on improving human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This document describes a physical medical device (stent and catheter), not an artificial intelligence algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and effectiveness profile of the predicate devices. The new device's characteristics are compared against these known, approved devices. For the non-clinical design verification, the "ground truth" would be established engineering specifications, material properties, and performance benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable. (See point 8).

In Summary:

This document is a 510(k) summary demonstrating substantial equivalence for a medical device. It does not contain information about clinical acceptance criteria or a study designed to prove device performance against such criteria in the way one might expect for an AI/algorithm submission. Instead, the proof of safety and effectiveness relies on its similarity to already-approved predicate devices and non-clinical design verification tests, which are not detailed in this summary. The FDA's letter in the provided text indicates their determination of substantial equivalence, allowing the device to be marketed.

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