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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 is a balloon-expandable, laser- cut stent made from 316L Stainless Steel tubing. The stent is sold mounted on a Cordis SLALOM percutaneous transluminal angioplasty (PTA) balloon catheter. The stent is provided in nominal, unexpanded stent lengths from 12 – 39 mm. The stent is designed for expansion to diameters from 3 - 8 mm, depending on the diameter of the associated balloon upon which it is mounted with system lengths of 80 cm and 135 cm. The delivery system utilizes an over-the-wire (OTW) dual lumen design and is a PTA balloon catheter with a distal DURALYN™ balloon and a proximal Y-connector. The balloon has two radiopaque markers that aid in stent placement within the stenosis and is designed with a known diameter and length. The Y-connector has an injectate lumen (marked "THRU") that is used to inject contrast medium via hand injection and to track the catheter over a guide wire up to .018". The inflation lumen (marked "BALLOON") is used to inflate and deflate the balloon with a contrast medium/saline mixture. The nominal balloon size and length is printed on the Y-connector. A metal introducer tube is included in the packaging. The PALMAZ GENESIS Transhepatic Biliary stent on SLALOM .018" Delivery System is provided sterile (via ethylene oxide) and is intended for single use only

The provided text describes a 510(k) premarket notification for the PALMAZ® GENESIS™ Transhepatic Biliary Stent. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner typically found for AI/ML-driven devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicit, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics given for this medical device. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical design verification tests and analyses.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

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

The document does not report any clinical test set or patient data (retrospective or prospective) used to evaluate the device's performance in the context of its intended use. The performance data is stated to be derived from "non-clinical design verification tests and analyses."

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Since no clinical test set or human-in-the-loop study is described, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set:

As no clinical test set is described, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was done or reported. The submission does not involve AI assistance, so a comparison of human readers with vs. without AI assistance is not applicable.

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

This device is a physical medical stent, not an AI algorithm. Therefore, a "standalone algorithm-only performance" study is not applicable.

7. The Type of Ground Truth Used:

The document states that the "safety and effectiveness... has been demonstrated via data collected from non-clinical design verification tests and analyses." This implies that the 'ground truth' for these tests would be based on engineering specifications, material science properties, and physical testing standards for devices of this type, rather than clinical outcomes, pathology, or expert consensus on patient data.

8. The Sample Size for the Training Set:

This device is a physical stent and its approval is based on substantial equivalence and non-clinical testing. It is not an AI/ML device that requires a training set in the computational sense.

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

This question is not applicable as the device is not an AI/ML algorithm that requires a training set.

Summary based on the document:

The 510(k) submission for the PALMAZ® GENESIS™ Transhepatic Biliary Stent is a premarket notification for a physical medical device. The acceptance criteria and proof of performance are based on non-clinical design verification tests and analyses demonstrating that the device is substantially equivalent to an existing predicate device. The document does not contain information about clinical studies with patient data, expert review, or AI/ML performance metrics.

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The Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent is indicated for 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 text describes a 510(k) submission for a medical device, the Cordis PALMAZ GENESIS Transhepatic Biliary Stent. The submission focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics in the way a novel device might.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided document, as the regulatory pathway chosen (510(k) for substantial equivalence) typically relies on non-clinical data and comparison to existing devices.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Cordis PALMAZ GENESIS Transhepatic Biliary Stent (see 510(k) #K012090);
• Cordis PALMAZ GENESIS Transhepatic Biliary Stent on .035 OPTA PRO . Delivery System (see 510(k) #K012590); and,
• Cordis PALMAZ Balloon-Expandable Stent for use in the biliary system (see 510(k) . #K905720 and K911581)."
  "The subject PALMAZ GENESIS Transhepatic Biliary Stent is provided in nominal unexpanded lengths of 19-59 mm and is designed for expanded diameters of 10-12 mm." |
  | Safety and Effectiveness demonstrated via non-clinical design verification tests and analyses. | "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." (Specific performance metrics are not detailed in this summary.) |
  | Intended Use: Palliation of malignant neoplasms in the biliary tree. | Explicitly stated as the intended use. |

Explanation: In a 510(k) for substantial equivalence, the "acceptance criteria" are primarily met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through non-clinical testing (e.g., bench testing, mechanical testing, biocompatibility) rather than human clinical trials. The document explicitly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses." The specific parameters and thresholds for these tests are not provided in this summary.

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

• Sample size for test set: Not applicable and not mentioned. The document refers to "non-clinical design verification tests and analyses" which typically involve testing devices or components, not "test sets" of data in the context of AI or diagnostic algorithms.
• Data provenance: Not applicable. The "data" refers to results from non-clinical tests, not a dataset of patient information.

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

• Not applicable and not mentioned. This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the focus of this 510(k) submission.

4. Adjudication method for the test set

• Not applicable and not mentioned. This is typically for studies with human readers or image interpretation, not for demonstrating substantial equivalence of a physical stent through non-clinical testing.

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.

• No. An MRMC study was not done. This device is a physical stent, not an AI or diagnostic algorithm, so such a study would not be relevant.

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

• No. This is a physical medical device (stent), not an algorithm.

7. The type of ground truth used

• Non-clinical testing standards and specifications: The "ground truth" for this type of device and submission would be defined by engineering specifications, material properties, mechanical performance thresholds (e.g., radial strength, fatigue life), and biocompatibility standards. These are established through recognized industry standards and internal design requirements. The document refers to "non-clinical design verification tests and analyses," which would assess the device's adherence to these standards.

8. The sample size for the training set

• Not applicable and not mentioned. This concept is relevant for machine learning models, not for the regulatory approval of a physical stent through a substantial equivalence pathway.

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

• Not applicable and not mentioned. As above, this is for machine learning models.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence for a physical medical device (biliary stent) based on non-clinical data and comparison to existing predicate devices. It is not an AI/algorithm-based device and therefore the questions pertaining to test sets, ground truth, experts, and AI performance metrics are not applicable to this document. The "study" mentioned is the collection of "non-clinical design verification tests and analyses" which demonstrated the device's safety and effectiveness compared to its predicates.

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