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The Wedge XL Delivery Catheter is intended to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

The Wedge XL Delivery Catheter is a single lumen catheter designed to be introduced over a steerable quidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Radiopaque markers at the distal end facilitate fluoroscopic visualization. A larger diameter distal segment helps provide stability for navigation. The distal 110 cm outer surface of the Wedge XL Delivery Catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Wedge XL Delivery Catheter hub is used for the attachment of accessories.

This document describes the regulatory approval of the MicroVention, Inc. Wedge XL Delivery Catheter (K232542) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and performance data in the typical format of a clinical trial for an AI/software device.

The information provided confirms that the device is a percutaneous catheter, not an AI/software as a medical device (SaMD). Therefore, the questions regarding acceptance criteria and performance studies specifically for AI/Software (e.g., test set, ground truth, expert adjudication, MRMC studies) are not directly applicable in the format requested.

However, I can extract the information relevant to the device's performance testing and general acceptance:

The submission demonstrates the device meets acceptance criteria through a series of bench testing and an animal study, alongside biocompatibility evaluation and sterilization information. The overall acceptance criterion is substantial equivalence to the predicate device (Wedge Microcatheter K172014) and a reference device (Delivery Catheter of the Route 92 Medical 088 Access System K200121).

Here's a breakdown of the provided information within the context of a medical device submission:

Acceptance Criteria and Reported Device Performance (Table Format - Adapted for a Non-AI Device):

For the points specifically pertaining to AI/ML device studies, the following is direct or inferred from the document:

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

   • This is not an AI/ML device. For bench testing, samples are typically physical units. For the animal study, it mentions a "porcine model," implying a number of animals were used, but the specific count is not provided. The study followed GLP (Good Laboratory Practice) Regulation (21 CFR Part 58), indicating a controlled, prospective study. The origin is a "porcine model," which is not human data.

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

   • Not applicable as this is not an AI/ML device. Ground truth for device performance would be established through physical measurements, chemical analyses, and histopathological evaluation by trained personnel (e.g., lab technicians, pathologists) in the animal study, but the specific number and qualifications are not detailed beyond "Good Laboratory Practice (GLP)".

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

   • Not applicable as this is not an AI/ML 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 as this is not an an AI-driven or diagnostic device that involves human reader interpretation.

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

   • Not applicable. This is a physical medical device.

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

   • For bench testing: Physical measurements, performance metrics based on engineering and material science standards.
   • For biocompatibility: Laboratory assays with established controls and reference standards.
   • For the animal study: Pathology (histological impact on arterial sections, postmortem examination for gross findings), and outcomes data (safety and performance of catheter tracking, vascular response to device use).

8. The sample size for the training set:

   • Not applicable as this is not an AI/ML device that requires a training set.

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

   • Not applicable.

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