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The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

The ViperCross™ Support Catheters are single lumen catheters designed for use in the peripheral vasculature. The ViperCross™ Support Catheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross support catheters have a hydrophilic coating on the distal 30cm, 40cm, 70cm, or 90cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have three (3) radiopaque marker bands located 0.040" / 1.01mm, 1.968" / 50mm, and 3.937" / 100mm from the distal tip, respectively. The 135cm and 150cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

The 014 or 018 ViperCross™ Support Catheter can be placed through the 035 ViperCross™ Support Catheter for extended reach and pushability.

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

The provided text is a 510(k) premarket notification regarding a medical device, the ViperCross™ Support Catheter. It outlines the device's intended use, indications for use, technological comparison to a predicate device, and performance testing.

However, it does not contain any information about an AI/ML powered device, associated acceptance criteria, specific study designs (like MRMC), sample sizes for training/test sets for AI, ground truth establishment for AI, or expert adjudication for AI..

The "Performance Testing" section lists various engineering and material tests conducted on the physical catheter, such as working length, leak tests, trackability, kink resistance, etc. These are standard tests for a physical medical device and do not relate to the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the provided text, as the document describes a physical medical device and its traditional performance testing, not an AI/ML-powered device.

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0.014"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents.

0.018" & 0.035"

The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

014: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral and/or coronary vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm or 70cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

018/035: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm, 70cm, or 40cm dependent on model length to enhance deliverability to the target vasculature.

The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The 135cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing.

The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

The acceptance criteria and study proving the device meets them are:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily states that "All testing met the requirements and passed." Specific quantitative acceptance criteria or numerical performance results are not detailed in the provided text. The performance testing categories are listed below:

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

The document does not specify the sample size for individual tests. It also does not explicitly state the provenance of the test data (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench testing and materials characterization rather than clinical studies with patient data.

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

This information is not applicable and not provided in the document as the testing described is not clinical and does not involve establishing ground truth from expert interpretations.

4. Adjudication method for the test set:

This information is not applicable and not provided in the document, as no human adjudication is mentioned for the described performance 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:

This information is not applicable and not provided in the document. The device is a physical medical device (ViperCross Support Catheters), not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

This information is not applicable and not provided in the document, as the device is not an algorithm or AI system.

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

For the performance testing mentioned, the "ground truth" would be established by engineering specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility), and established test methodologies designed to assess the physical and mechanical properties of the device.

8. The sample size for the training set:

This information is not applicable and not provided in the document, as this is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided in the document, as this is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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