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The Aventus Thrombectomy System is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Aventus Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for the minimally invasive removal of emboli and thrombi from blood vessels, infusing fluids, and is intended to be used in the peripheral vasculature and for the treatment of pulmonary embolism. The System is comprised of the following major components:

• Aventus Thrombectomy Catheter
• Clot Management System consisting of:
  • Aspiration Syringe
  • Clot Canister

The System is compatible with a standard 24-French (24F) introducer sheath, 4F Navigation Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.

The Aventus Thrombectomy Catheter includes an atraumatic radiopaque Distal Tip with embedded sensors, and an angled aspiration orifice for directional aspiration and navigation without a dilator. The Catheter Handle assists the clinician in navigating within the vasculature and includes a Sensing Indicator and houses the Sensing electronics. The Aspiration Catheter shaft incorporates a metallic reinforcement layer made of stainless steel, an inner liner and polymeric outer jacket having variable stiffness.

The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.

The provided text describes the regulatory clearance of a medical device, the Aventus Thrombectomy System, and outlines the performance data submitted to support its substantial equivalence. However, the document does NOT contain information about an AI/Software component that would require "acceptance criteria" based on metrics like sensitivity, specificity, accuracy, or an MRMC study.

The software testing mentioned refers to:

• "Software documentation was leveraged from the reference device as recommended by FDA Guidance: Content of Premarket Submissions for Device Software Functions, issued June 14, 2023." This indicates that the software functions are likely related to guiding the device's operation, sensing, or control rather than an AI-driven diagnostic or interpretative function. There is no mention of AI, machine learning, or algorithms for image analysis or diagnostic support.

Therefore, I cannot provide the requested information about acceptance criteria, test set details (sample size, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details because the provided document does not indicate the presence of such an AI/ML component.

The performance data listed pertains to the physical device itself (biocompatibility, sterilization, packaging, electrical safety, bench testing, animal studies, and a clinical trial on the device's safety and effectiveness in treating pulmonary embolism).

If the device did indeed have an AI/ML component, the type of information you requested (acceptance criteria, ground truth establishment, MRMC study, etc.) would be critical for its regulatory clearance. Based on the provided text, the Aventus Thrombectomy System appears to be a mechanical thrombectomy device with some electronic/software components for its control and sensing, but not for AI-assisted image analysis or diagnostic capabilities.

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