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The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.

The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.

The provided text describes a 510(k) premarket notification for a medical device, the SOFIA Plus Aspiration Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided does not align with the typical structure of an AI/ML medical device study demonstrating algorithmic performance against acceptance criteria.

The document primarily details the pre-clinical testing on the device itself and an animal study to evaluate its aspiration performance and safety. It does not describe an AI/ML algorithm or a study of its performance.

However, I can extract and structure the information about the acceptance criteria and performance of the physical device based on the provided text, while acknowledging that this is not an AI/ML study.

Here's an interpretation of the request using the available information:

The SOFIA Plus Aspiration Catheter underwent extensive pre-clinical testing to demonstrate its performance and substantial equivalence to a predicate device. The acceptance criteria for these tests were typically defined by established specifications, industry standards (e.g., ISO), or direct comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for each bench test. Instead, it refers to "test articles" and general results (e.g., "Test articles achieved a rating...") and in some cases, "two out of two test sites" for the animal study.

• Test Set Provenance: The tests are pre-clinical bench tests performed by the manufacturer (MicroVention, Inc., Tustin, California, USA) and an animal study (swine model). The information does not specify the country of origin of data in terms of retrospective/prospective human patient data, as this is not a human clinical trial. All tests would have been performed prospectively as part of the device development and submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the document describes pre-clinical physical device testing and an animal study, not an AI/ML algorithm study that requires expert adjudication of image-based ground truth. For the simulated-use tests, the performance ratings (e.g., $\geq3$) would be based on qualitative assessment by trained personnel, but they are not referred to as "experts" in the context of clinical ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/ML algorithm study involving interpretation of clinical data by multiple readers, there is no need for an adjudication method like 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this was not done. This document pertains to the 510(k) clearance of a physical medical device. MRMC studies are typically performed for AI-driven diagnostic or assistive technologies to assess their impact on human reader performance.

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

No, this was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering Specifications and Standards: For dimensional, mechanical, and safety properties (e.g., ISO standards, specified psi limits, force at break criteria).
• Comparative Performance to Predicate Devices: Performance attributes (e.g., stiffness, vacuum pressure, torque response) were compared to the legally marketed predicate device (Penumbra Reperfusion Catheter ACE64 and ACE68).
• Animal Study Observations: For aspiration performance and histopathological evaluations in a swine model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML study, therefore there is no training set for an algorithm.

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

Not applicable. As there is no AI/ML algorithm training set.

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