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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 Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. 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 GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.

The provided document is a 510(k) summary for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent). This type of document focuses on demonstrating substantial equivalence to a previously approved device, rather than proving performance against specific acceptance criteria through a clinical trial or a standalone study.

Therefore, many of the requested points, especially those related to acceptance criteria, specific device performance numbers, and study designs (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance), are not typically found or required in a 510(k) submission for this type of device.

Here's an analysis based on the provided text, addressing what can be found and explicitly stating what cannot:

1. A table of acceptance criteria and the reported device performance

• Not Applicable / Not Provided. This document does not describe acceptance criteria in terms of quantitative performance metrics for a specific study, nor does it report specific device performance numbers against such criteria. The focus is on demonstrating "substantial equivalence" to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Provided. No test set, sample size, or data provenance information (country, retrospective/prospective) is included. The demonstration of safety and effectiveness relies on "non-clinical design verification tests and analyses" and substantial equivalence to a predicate, not a clinical study on a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. There is no mention of experts establishing a ground truth for a test set, as no such clinical test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No adjudication method is described, as there is no clinical test set requiring expert review.

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 / Not Provided. This device is a transhepatic biliary stent, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related performance metrics are irrelevant and not part of this submission.

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

• Not Applicable / Not Provided. This is a physical medical device (stent), not an algorithm. Standalone performance for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. No clinical ground truth is described in the context of this 510(k) summary. The "ground truth" for demonstrating device compliance would be based on engineering specifications and bench testing against the predicate device's characteristics.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned or relevant for this type of device submission.

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

• Not Applicable / Not Provided. As there is no training set, there is no ground truth establishment for it.

Summary of what the document does provide regarding device performance and equivalence:

The document states:

• "The safety and effectiveness of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent have been demonstrated via data collected from non-clinical design verification tests and analyses."
• The device is "substantially equivalent to those featured with the predicate Cordis BX Transhepatic Biliary Stent and Delivery System (see 510(k) #K001258)."
• The "design, material, components, accessories, method of delivery, fundamental technology and intended use featured with the Cordis PALMAZ GENESIS Transhepatic Biliary Stent are substantially equivalent to those featured with the predecessor Cordis BX Transhepatic Biliary Stent and Delivery System."

In essence, the "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the new device shares fundamental technological characteristics, intended use, and similar performance to the predicate device through non-clinical testing, rather than meeting specific quantifiable performance metrics from a new clinical study.

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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The PALMAZ GENESIS Transhepatic Biliary Stent on SLALOM .018" Delivery System is a balloon-expandable, stainless steel stent that is provided premounted upon the Cordis SLALOM balloon catheter (ref. K003159). The stent is provided in four nominal, unexpanded stent lengths: 12, 15, 18 & 24 mm. The stent is designed for expansion to diameters from 3 to 6 mm, depending on the diameter of the associated balloon upon which it is mounted. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile and is intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device (Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on SLALOM™ .018" Delivery System), not a study that establishes acceptance criteria and proves the device meets those criteria.

The 510(k) process is used to demonstrate that a device is substantially equivalent to a predicate device, meaning it is at least as safe and effective. It does not typically involve the establishment of new acceptance criteria through clinical studies in the same way an investigational device exemption (IDE) or premarket approval (PMA) application would for novel devices.

Here's a breakdown based on the provided text, highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable/Not provided. The document refers to "non-clinical design verification tests and analyses," which are typically bench testing and engineering verification, not human clinical trials with 'sample size' in the traditional sense of patient numbers.
• Data Provenance: Not applicable/Not provided. Since it's described as "non-clinical design verification," there is no country of origin for patient data or retrospective/prospective classification.

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

• Not applicable/Not provided. This information pertains to studies where human experts evaluate cases to establish a "ground truth" (e.g., diagnosing disease from images). The provided text describes engineering verification tests, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. Pertains to expert review, which is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not mention any MRMC study, human reader performance, or AI assistance. The device in question is a physical medical device (stent), not a diagnostic AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This question is also not applicable as the device is a physical stent, not an algorithm.

7. Type of Ground Truth Used:

• Not explicitly stated in terms of "ground truth" for a clinical outcome. The "effectiveness" is demonstrated through "non-clinical design verification tests and analyses." This would imply that the "ground truth" for these tests would be compliance with engineering specifications, material properties, mechanical performance, etc., as determined by validated test methods.

8. Sample Size for the Training Set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/algorithm-based device.

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

• Not applicable/Not provided. (Refer to point 8).

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical design verification tests and analyses for a physical medical device (biliary stent). It explicitly states that "Performance standards have not been established for this device by the FDA under section 514 of the Food, Drug and Cosmetic Act." Therefore, the document does not contain the information about acceptance criteria, clinical study designs, sample sizes for patient data, expert ground truth establishment, or AI-related metrics that your prompt requests.

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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is intended for use in the palliation of malignant neoplasms in the biliary tree.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is a balloon-expandable, stainless steel stent that is provided unmounted (without its recommended balloon catheter delivery device). The Cordis OPTA® PRO Balloon Catheter is recommended for the delivery of the Cordis PALMAZ GENESIS Transhepatic Biliary Stent.

The Cordis PALMAZ GENESIS Transhepatic Biliary Stent is hand crimped upon its recommended balloon catheter delivery device. 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 GENESIS Transhepatic Biliary Stent is provided sterile (via gamma irradiation) and is intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed as "non-clinical design verification tests and analyses."

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

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation was based on non-clinical design verification tests and analyses. This typically refers to bench testing, engineering studies, and material characterization, not patient data in the context of a "test set" as one might find in an AI/software device.
• Data Provenance: Not applicable in the context of clinical data for a "test set." The data provenance for the non-clinical tests would be the Cordis Corporation's internal R&D and testing facilities.

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

• This information is not provided in the document. Given that the study was non-clinical design verification, the concept of "experts establishing ground truth for a test set" in the medical imaging or diagnostic sense is not directly applicable. Expertise would have been in engineering, material science, and regulatory compliance.

4. Adjudication Method for the Test Set:

• This information is not provided and is not applicable for non-clinical design verification tests. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done.
• AI vs. Human Improvement Effect Size: Not applicable, as this is a medical device (stent) and not an AI or software-as-a-medical-device (SaMD) being evaluated for human reader assistance.

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

• No, a standalone algorithm performance study was not done. This device is a physical medical implant (stent) and does not involve an algorithm.

7. The Type of Ground Truth Used:

• The ground truth for the non-clinical design verification tests would be established through engineering specifications, material standards, mechanical testing results, and established scientific principles relevant to the performance and safety of a medical implant. For example, stent radial strength might be compared against a pre-defined engineering specification.

8. The Sample Size for the Training Set:

• This information is not provided and is not relevant. The device is a physical stent developed through traditional engineering and manufacturing processes, not an AI or machine learning model that requires a "training set."

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

• This information is not provided and is not relevant, as there is no "training set" in the context of this device. Development processes would involve design, prototyping, and iterative non-clinical testing against engineering requirements.

In summary, the provided document describes a traditional medical device (stent) clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device and proving safety and effectiveness through non-clinical (bench) testing. It does not involve AI/ML components or clinical performance studies with human readers.

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