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The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.

The VIA™ 21 Microcatheter is 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 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 VIATM 21 Microcatheter is a sterile single lumen device 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™ 21 Microcatheter is available in an effective length of 154 cm and an inner diameter of 0.021 inches.

The VIA™ 21 Microcatheter is presented in a tyvek pouch and is sterile, single use only and non-pyrogenic.

Accessories: Each VIA™ 21 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.

The provided document describes the VIA™ 21 Microcatheter and its non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested categories for AI/ML performance evaluation are not applicable to this document. The document focuses on the physical and functional characteristics of a medical device (a microcatheter).

However, I can extract the acceptance criteria and performance data for the device itself based on the provided text.

Here's the information derived from the document, with "N/A" for sections not relevant to this type of device and study:

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

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

The document does not explicitly state sample sizes for each bench test, but refers to "Simulated Use Testing in Animals" with results summarized as "no new risks were identified and that the safety and effectiveness profile is similar to well-established comparison market-approved devices." This suggests animal testing was performed. The provenance is likely prospective as part of the device development and validation.

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

N/A. This is a physical device, and the testing involves engineering and materials science principles, not expert interpretation of outputs like in an AI/ML system.

4. Adjudication method for the test set

N/A. Not applicable to engineering bench 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

N/A. This is a physical medical device, not an AI/ML algorithm.

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

N/A. This is a physical medical device.

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

The ground truth for most of these tests relies on established engineering standards (ISO, ASTM, BS EN) and internal Sequent Test Methods (TM), which define acceptable physical, mechanical, and functional properties of catheters. For the biocompatibility testing, accepted biological endpoints (e.g., non-pyrogenic, non-toxic, non-hemolytic) serve as the ground truth.

8. The sample size for the training set

N/A. This is a physical medical device. There is no "training set" in the context of AI/ML.

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

N/A. This is a physical medical device.

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