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The VIATM Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral and coronary vasculature.

The VIA™ Microcatheter and VIA™ PLUS Microcatheter are designed to be introduced over a steerable guidewire into the vasculature. The physician inserts the catheter into the vein or artery through the skin (percutaneous) using a sheath or guidewire. The device can then be navigated to the treatment site. Navigation is aided by the coated surface of the catheter which assists with manipulation while in the vasculature. Throughout the procedure the physician can obtain the position of the catheter by the tip marker using fluoroscopic techniques. Diagnostic, therapeutic and interventional devices can be delivered through the lumen of the catheter to the treatment site.

The VIA™ Microcatheter is a sterile single lumen device with one distal tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Variable shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aid the physician in tracking over selectively placed guidewires. The proximal end of the catheter incorporates a standard luer adapter to facilitate attachment of accessories. A single radiopaque marker positioned at the distal tip facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating which reduces friction during manipulation in the vessel. The inner lumen of the catheter has a PTFE liner which assists with delivery of interventional devices, such as an intraluminal flow diverter.

The VIA™ and VIA™ PLUS Microcatheter is available in effective lengths of 154 cm and 133 cm and inner diameters of 0.27 inches and 0.33 inches respectively. For commercialization purposes the 0.027 inch diameter will be named the VIATM Microcatheter and the 0.033 inch diameter will be named the VIA™ PLUS Microcatheter.

The VIA™ Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ Microcatheter is provided with a shaping mandrel to facilitate distal tip shaping.

In intravascular procedures, the device assists the physician in:

• . Accessing the targeted vasculature to facilitate the delivery of interventional devices, such as intraluminal flow diverters, infusion of diagnostic agents such as , contrast and infusion of therapeutic agents.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating "substantial equivalence" to predicate devices rather than establishing novel safety and effectiveness criteria through studies like those for AI/ML devices. Therefore, much of the requested information (such as acceptance criteria, specific performance metrics, sample sizes for test sets, expert consensus for ground truth, and MRMC studies) is not typically present in this type of submission.

Here's a breakdown of what can be extracted based on the provided text:

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

The document does not explicitly present acceptance criteria in a quantitative table format that would typically be seen for AI/ML performance. Instead, it relies on demonstrating that the new device, the VIA™ Microcatheter, performs comparably to its cleared predicate devices. The "performance" is generally described as the device being able to be used for its intended purpose and showing "substantial equivalence" to the predicates.

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

The document mentions "Performance testing included: Bench Testing, Sterilization Validation, Packaging and shelf life testing, Biocompatibility testing, Simulated use testing in Animals."

• Sample Size: Not specified for any of these testing types.
• Data Provenance: Not specified. It can be inferred that animal testing would be prospective, but no details on the origin of the animals or other testing data are provided.

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

This information is not provided. The testing appears to be primarily engineering and biological validation rather than clinical studies requiring expert interpretation for ground truth.

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

Not applicable/not provided. This type of adjudication is typically for clinical image interpretation or diagnostic tasks, which are not the focus of this device’s validation.

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 microcatheter, not an AI/ML diagnostic aid. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to its validation.

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)

The "ground truth" for this device's validation is based on:

• Engineering specifications and regulatory standards: For bench testing of physical properties.
• Biological responses: For biocompatibility testing (e.g., cell culture tests, animal implantation responses).
• Sterilization efficacy: For sterility validation.
• Successful navigation and delivery: In "Simulated use testing in Animals." This would involve observing the physical device's performance in a live system.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. There is no training set for this device.

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