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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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The RX HERCULINK™ 14 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.

RX HERCULINK™ 14 Biliary Stent System is a balloon-expandable stent pre-mounted onto a rapid exchange (RX) delivery catheter designed to be placed perculaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The Stent is pre-mounted onto an RX delivery catheter with an integrated shaft system and an of a single have a look balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated.

The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the catheter has a single arm adapter that provides access to the The proximal end of the catherer has a ongro annelly for connection with an inflation device.

The RX HERCULINK™ Biliary Stent System consists of an 18 mm length stent pre-The KA TILICOEINN - Dinary Catheter with balloon diameters of 4.0, 4.5, 5.0, mounted only a 75 cm length don'tory actively Stent System is intended to be delivered and deployed in the biliary tree.

Here's an analysis of the provided text regarding the RX HERCULINK™ 14 Biliary Stent System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary from 1999 for a medical device (biliary stent), not a diagnostic algorithm or AI system. Therefore, many of the requested categories (like MRMC studies, ground truth for training/test sets, expert adjudication, effect size of human readers with AI assistance) are not applicable to this type of device and submission. The "device" in this context is a physical stent and delivery system.

The "acceptance criteria" for a physical medical device typically revolve around demonstrating substantial equivalence to a predicate device in terms of design, materials, performance, and intended use, rather than meeting specific sensitivity/specificity thresholds. The "study" proving acceptance criteria is often a series of bench tests and analyses to show that the new device performs similarly to the predicate or meets established engineering specifications.

Here's a breakdown 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

• Sample Size: Not specified in terms of number of devices tested for the in vitro bench tests. The document only states "data collected from in vitro bench tests and analyses," implying multiple tests were performed.
• Data Provenance: The tests are "in vitro bench tests," meaning they were conducted in a laboratory setting, not on human patients or derived from clinical data. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical sense.

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

• Not Applicable. For a physical device like a stent, "ground truth" isn't established by expert consensus on clinical findings in the same way it would be for an AI diagnostic algorithm. Performance is typically measured against engineering specifications, material properties, and mechanical test standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel performing the bench testing, not clinicians establishing clinical ground truth.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers when establishing ground truth for diagnostic studies. This is not relevant for in vitro bench testing of a physical medical device.

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 is a physical medical device (stent), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Engineering Specifications / Performance Standards: The "ground truth" for this device's performance would be adherence to established engineering specifications, material standards (e.g., for 316L stainless steel), and mechanical performance metrics (e.g., expansion diameter at certain pressures, stent integrity, delivery system functionality). The bench tests verify that the device meets these pre-defined physical and mechanical properties.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

• Not Applicable. As there is no training set for a physical device, this question does not apply.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is described as "in vitro bench tests and analyses." These tests are designed to demonstrate the "safety and effectiveness" of the stent system by verifying its physical, mechanical, and material characteristics against predetermined specifications and in comparison to the predicate device. The ultimate acceptance criterion for a 510(k) summary is "substantial equivalence" to a legally marketed predicate device (in this case, the Cordis J&J PALMAZ™ balloon-expandable Stent, K911581). This substantial equivalence is established by showing that the new device has similar designs, materials, methods of deployment, and intended use as the predicate, which the bench testing would support.

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The Cordis PERFLEX Stainless Steel Stent and Delivery System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The Cordis PERFLEX Stainless Steel Stent and Delivery System consists of the following components:

• The balloon-expandable PERFLEX Stainless Steel Stent; .
• A delivery balloon catheter (either the Cordis PowerFlex or OPTA 5 Balloon . Catheter, depending on the stent size); and,
• . An insertion tool.

The Cordis PERFLEX Stainless Steel Stent and Delivery System features a balloonexpandable, stainless steel, welded wire stent that is delivered by a balloon catheter. The stent is provided premounted upon its associated balloon catheter. The Cordis PowerFlex and OPTA 5 Balloon Catheters are used for the delivery of the PERFLEX Stainless Steel Stents. The Cordis PERFLEX Stainless Steel Stent and Delivery System is advanced over a guidewire through a sheath lumen to an obstruction site in the biliary tree where the balloon is inflated to expand the stent. The balloon is then deflated and removed.

Also included with the Cordis PERFLEX Stainless Steel Stent and Delivery System is a stainless steel insertion tool that can be placed within the hemostatic valve of a commercially available introducer sheath to protect the stent / balloon catheter assembly during its insertion. Once the stent/balloon assembly passes through the valve, the insertion tool is removed.

The Cordis PERFLEX Stainless Steel Stent and Delivery System is provided sterile and is intended for single use only.

This document, a 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System, focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness criteria through a new clinical study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific study design, and performance metrics is not present in this submission.

Here's a breakdown of what can be extracted and what is not applicable:

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

This information is not provided in the document. The 510(k) summary for the Cordis PERFLEX Stainless Steel Stent and Delivery System states: "The safety and effectiveness of the Cordis PERFLEX Stainless Steel Stent and Delivery System have been demonstrated via data collected from nonclinical tests and analyses." It does not provide specific acceptance criteria or reported device performance metrics from a clinical study. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the established safety and effectiveness of those predicates are sufficient.

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

This information is not provided in the document. The submission references "nonclinical tests and analyses," which are typically bench tests or animal studies, not human clinical trials. Thus, there is no "test set" in the context of human data.

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)

This information is not provided in the document. As there is no human "test set" or clinical study with ground truth established by experts, this is not applicable.

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

This information is not provided in the document. Not applicable as there is no human test set requiring adjudication.

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

This information is not provided in the document. MRMC studies are typically for AI/diagnostic imaging devices. This device is a medical implant (stent), and its approval process does not involve MRMC studies or AI assistance.

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

This information is not provided in the document. This is not an AI algorithm but a physical medical device; therefore, "standalone algorithm performance" is not applicable.

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

This information is not provided in the document beyond the mention of "nonclinical tests and analyses." For a physical device like a stent, ground truth in nonclinical tests would likely involve engineering specifications, materials testing results, and potentially animal model outcomes demonstrating mechanical integrity, patency, and biocompatibility, as compared to predicate devices.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" in the context of machine learning or AI. For nonclinical tests, the "sample size" would refer to the number of devices tested, but this detail is not given.

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

This information is not provided in the document. Not applicable, as there is no training set in the context of AI. For nonclinical tests, the "ground truth" would be established by validated measurement techniques and adherence to engineering standards.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting a new clinical study with specific acceptance criteria, and reporting performance against those criteria, the manufacturer is arguing that their new device is fundamentally similar in design, materials, components, method of delivery, and intended use to devices already cleared by the FDA. The "performance data" mentioned refers to nonclinical tests that confirm the new device's characteristics align with those of the predicate devices and meet established engineering and biocompatibility standards. The FDA's clearance (K980653) confirms that they found the device to be substantially equivalent.

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