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The Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The PALMAZ BLUE Transhepatic Biliary Stent is a balloon expandable Cobalt Chromium Biliary stent. The stent is provided premounted on a balloon catheter, i.e., the Cordis SLALOM 0.18" Delivery System. The stent and delivery system are advanced over a guidewire through a sheath lumen, via the use of a stainless steel introducer tube accessory, (which is provided together with the Palmaz BLUE .018 Transhepatic Biliary Stent 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 subsequently the delivery system is removed. The Cordis PALMAZ BLUE .018 Transhepatic Biliary Stent System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.

The provided 510(k) summary (K040413) for the Cordis Palmaz® BLUE™ .018 Transhepatic Biliary Stent System details its safety and effectiveness through substantial equivalence to predicate devices, rather than through presenting acceptance criteria and a study demonstrating the device meets those criteria.

Therefore, the requested information elements related to specific acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert reviews, and comparative effectiveness studies are not contained within the provided document.

The document focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices.

Here's a breakdown of what is available regarding safety and effectiveness, based on the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not available. The document does not specify quantitative acceptance criteria or report specific device performance metrics in numerical form. It relies on demonstrating substantial equivalence to predicate devices.

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

• Not available. The document states that safety and effectiveness were demonstrated via "non-clinical in-vitro and animal testing (stent placement in biliary duct)". It does not provide sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective) beyond stating it was non-clinical.

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

• Not available. Ground truth establishment by experts for a test set is not described, as the evaluation was non-clinical.

4. Adjudication method for the test set:

• Not available. Adjudication methods are not applicable to the non-clinical testing described.

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 device is a transhepatic biliary stent system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.

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

• Not applicable. See point 5.

7. The type of ground truth used:

• Implied non-clinical data: The document refers to "non-clinical in-vitro and animal testing (stent placement in biliary duct)". The "ground truth" here would likely be derived from measurements, observations, and histological findings from these non-clinical tests demonstrating stent function, patency, and biocompatibility in the animal model. It is not an expert consensus, pathology, or outcomes data from human patients.

8. The sample size for the training set:

• Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not applicable. See point 8.

Summary of Studies (from the document):

The document explicitly states:

• "The safety and effectiveness of the device and the substantial equivalence to the predicate devices have been demonstrated via data collected from non-clinical in-vitro and animal testing (stent placement in biliary duct) which was prescribed in the FDA's – Guidance for the content of premarket notifications for metal expandable biliary stents. February 5, 1998."
• "The Cobalt Chromium based stent material has been tested according to the ISO10993 part 1 and were concluded biocompatible."

The 510(k) submission relies on demonstrating substantial equivalence to already cleared predicate devices, citing similarities in:

• Intended use
• Components
• Dimensions (size range)
• Accessories
• Method of delivery
• Fundamental technology (operating principle)
• Packaging configuration and materials
• Manufacturing and sterilization processes
• Stent material (Cobalt Chromium-alloy, comparing to components in knee implants)

This approach is common for medical devices where a new device is similar enough to an existing one that extensive new clinical trials are not required for market clearance.

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The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.

The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.

The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.

Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.

The provided text is a 510(k) Premarket Notification for Cordis PTA Balloon Catheters, and it does not include information about a study proving the device meets specific acceptance criteria in the way a clinical trial or AI/ML performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on non-clinical design verification tests and analyses. This approach is typical for 510(k) submissions where the new device is very similar to an already approved one.

Therefore, many of the requested points related to acceptance criteria, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable or discoverable in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria and reported device performance in the context of a clinical performance study with defined metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "performance" demonstrated is that the modified devices are "virtually identical" to their original cleared devices, with changes limited to non-clinical aspects like hub material and design configuration for user preference. The regulatory "acceptance criteria" here are implicitly that these minor design changes do not negatively impact the safety and effectiveness, and the device continues to meet the safety and performance of its predicate.

• Acceptance Criteria (Implicit): The modified devices demonstrate biocompatibility, and their non-clinical performance (e.g., inflation/deflation, tracking over a guidewire, radiopacity) is equivalent to the predicate devices, and the changes do not introduce new safety concerns.
• Reported Device Performance: "Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible."

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

• Test Set Size: Not applicable. This submission relies on non-clinical design verification tests, not a clinical test set with patient data.
• Data Provenance: Not applicable, as there are no patient data. The "data" are from non-clinical laboratory tests.

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

• Number of Experts: Not applicable. Ground truth as typically understood for clinical performance studies (e.g., diagnosis, lesion identification) is not established here.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There is no clinical 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:

• MRMC Study: No. This is a medical device (balloon catheter), not an AI/ML diagnostic or assistive device that would involve human readers.

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:

• Ground Truth: For biocompatibility, the "ground truth" is adherence to ISO 10993-Part 1 standards. For functional performance, the "ground truth" is equivalence in non-clinical bench testing to the predicate device. This is a technical (engineering/materials) ground truth, not a clinical ground truth.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component, so no training set.

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

• Not applicable.

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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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