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The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is a balloon-expandable, stainless steel stent that is provided mounted upon its balloon catheter delivery device. The Cordis JUPITER Balloon Catheters are used for the delivery of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent. These balloon catheters are substantially equivalent to the balloon catheter delivery devices used with the aforementioned predicate Cordis device.

The subject PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is advanced over a guidewire through a sheath lumen, via the use of a metal introducer tube accessory, which is also provided with the stent and its delivery 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 removed.

The Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System is provided sterile and is intended for single use only.

The provided text describes a 510(k) submission for a medical device, the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System. The acceptance criteria and supporting study are described in terms of substantial equivalence to a predicate device, rather than a clinical performance study with specific metrics like sensitivity or specificity. This is common for 510(k) submissions for devices that are line extensions or modifications of already cleared devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "The safety and effectiveness of the Cordis PALMAZ CORINTHIAN Transhepatic Biliary Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses."

• Sample Size: Not applicable in the traditional sense of a clinical study with patients. The nonclinical tests would have involved physical or mechanical testing of the device and its components. The specific number of devices tested or the specifications of those nonclinical tests are not detailed in this summary.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for nonclinical tests. These tests are typically conducted in a laboratory setting by the manufacturer.

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

• This information is not provided as the submission relies on nonclinical testing and substantial equivalence to a predicate device, not on expert-adjudicated clinical data.

4. Adjudication Method for the Test Set

• This information is not provided as the submission relies on nonclinical testing and substantial equivalence.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and nonclinical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• No, this is not an AI/algorithm-based device. It is a physical medical device (stent and delivery system), so a standalone algorithm study is not applicable.

7. The Type of Ground Truth Used

• For the purposes of this 510(k) submission, the "ground truth" is established through bench testing and engineering analysis demonstrating that the device performs as intended and is equivalent to the predicate device in terms of material properties, dimensions, deployment mechanism, and overall function. There is no biological or diagnostic "ground truth" as would be established through pathology or outcomes data for an AI or diagnostic device.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not applicable as there is no training set for this type of device.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared predicate device. The "study" proving the device meets the acceptance criteria (which is substantial equivalence) consists of nonclinical tests and analyses comparing the subject device's design, materials, components, and performance characteristics to those of the predicate. This approach is standard for line extensions of existing devices to streamline regulatory review when no new safety or effectiveness concerns are raised by the modifications. No clinical studies involving human subjects, expert adjudication, or AI model training are described or required for this type of submission.

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