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The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.

The Wedge Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The microcatheter has a semi-rigid proximal section with an outer shaft made of Grilamid nylon. The catheter shaft transitions to progressively softer durometers and different lengths of Polyether block amide (Pebax). The distal-most length of the microcatheter, beyond the enlarged segment, consists of a softer, atraumatic polyurethane.

The enlarged segment on the distal end of the Wedge is designed to reduce the gap between the OD of the guidewire and ID of the Sofia 6F. The tapered bulb section, approximately 1 cm length and located approximately 1.5 cm from the distal tip, can be identified on fluoroscopy between the two radiopaque proximal marker bands of the Wedge Microcatheter. The bulb OD (0.068") is sized specifically to work with the lumen ID (0.070") of the Sofia 6F allowing for continuous flush of saline through the Sofia.

Three radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer coating to reduce friction during navigation in the vasculature. The lubricious inner liner is made from polytetrafluoroethylene (PTFE). A luer fitting on the Microcatheter hub is used for the attachment of accessories. The hub/strain relief provides for the kink resistance at the proximal end. The microcatheter has a straight tip that is designed to be steam shaped by the physicians at the time of the use. A steam shaping mandrel and introducer sheath (accessories) are packaged with the catheter.

The provided document describes the MicroVention, Inc. Wedge Microcatheter and its substantial equivalence to predicate devices, rather than a standalone study with defined acceptance criteria and detailed device performance metrics in the way a clinical trial or a specific performance study for a diagnostic device might.

However, based on the Verification Test Summary and the Biocompatibility Evaluation sections, we can infer the acceptance criteria and reported device performance for various engineering and biological aspects. The "Results" column in these tables implicitly represents the device's performance against an unstated "Pass" acceptance criterion.

Here's an attempt to structure the information as requested, interpreting the "Pass" result as meeting the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For the tests marked with an asterisk (), the document states: "Testing was previously conducted on test article that was equivalent in all aspects relevant to the testing performed, therefore it was deemed unnecessary to repeat the testing for the Wedge Microcatheter." This implies these tests were accepted based on prior results on an equivalent device.*

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each specific verification test mentioned. The "Verification Test Summary" refers to tests conducted on the "subject device," implying direct testing of the Wedge Microcatheter.

• Animal Testing Summary: While not a "test set" in the sense of human patient data, the animal study compared the Wedge Microcatheter with the predicate Headway 21. It doesn't specify the number of animals used.
• Biocompatibility Evaluation: This section describes various in vitro and in vivo tests (e.g., Guinea pigs for sensitization, mice for systemic injection, rabbits for pyrogenicity). The numerical sample sizes for these animal models are not provided, nor is the country of origin. The data is prospective, generated specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document does not describe a scenario where "experts" are establishing ground truth for a test set in the context of clinical images or diagnostic outcomes. The tests performed are primarily engineering performance tests and biological reactivity tests. Therefore, this question is not applicable in the traditional sense for this type of device submission. The "ground truth" for these tests is established by standardized testing methods and validated experimental procedures.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The device performance is assessed through objective measurements and standard laboratory protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device submission for a microcatheter, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The tests performed are standalone in the sense that they evaluate the device itself, but not an algorithm.

7. The Type of Ground Truth Used

• Engineering/Performance Tests: The "ground truth" is based on established engineering standards and specifications for catheter performance (e.g., burst pressure, flow rate, force at break). These are objective, measurable outcomes.
• Biocompatibility Tests: The "ground truth" is based on the results of validated in vitro and in vivo biological assays comparing the device's interaction with biological systems against established thresholds for toxicity, irritation, sensitization, etc., as per ISO 10993-1:2009 and FDA guidelines.
• Animal Testing: The "ground truth" for the animal study (comparative performance and histopathology) was direct observation of the animal's vasculature and subsequent histopathological examination.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As this is not an AI or machine learning device, there is no training set or associated ground truth.

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