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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.

The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. 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 standard introducer sheaths (24F or 16F). 4F or 5F Navigation Catheters (based on Aventus Thrombectomy Catheter model), 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.

This document is a 510(k) Premarket Notification from the FDA regarding the Aventus Thrombectomy System. It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the provided text does not contain any information about an AI/software component that would require a study proving the device meets acceptance criteria related to AI performance, or any details about a clinical study involving human readers or ground truth establishment. The mentions of "software" and "refine the algorithm" are general and don't provide specifics on AI acceptance criteria or performance studies.

Therefore, I cannot fulfill your request for detailed information about acceptance criteria for an AI component, sample sizes for test sets, expert involvement in ground truth, MRMC studies, standalone performance, or training set details. This document primarily focuses on the physical device (catheter-based thrombectomy system) and its equivalence to a prior version, primarily through bench, biocompatibility, sterilization, packaging, and electrical safety testing.

The relevant information regarding software is:

• Software Testing: "Software documentation and testing was updated from the predicate device as recommended by FDA Guidance: Content of Premarket Submissions for Device Software Functions, issued June 14, 2023."
• Device Modification: "Update of the device software to refine the algorithm and account for the reduction in diameter."

These statements indicate that software was updated and tested according to FDA guidance, but they do not provide specific performance metrics, acceptance criteria for an AI algorithm (e.g., sensitivity, specificity, AUC), or details of a study setup that would validate such metrics. The "algorithm" mentioned likely refers to control or sensing algorithms for the catheter, not a diagnostic or prognostic AI.

In summary, the provided document does not contain the information needed to address your questions regarding AI acceptance criteria and study details.

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