Search Results

The ClotTriever Thrombectomy System is indicated for:

• The non-surgical removal of soft thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.

The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter consists of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.

This document describes the ClotTriever Thrombectomy System, a medical device for removing thrombi and emboli from blood vessels. However, the provided text does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm performance study.

The document is a 510(k) premarket notification summary for an updated version of the ClotTriever Thrombectomy System, comparing it to a previously cleared predicate device. The "acceptance criteria" discussed are related to non-clinical engineering and material tests to demonstrate that the modified physical device is substantially equivalent to the predicate device, not performance benchmarks for an AI or algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving the device meets those criteria, as well as the related details (sample size, experts, adjudication, MRMC, standalone, ground truth, training set details) because this information is not present in the provided text.

The "Non-Clinical Testing" section explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This further confirms that no human-centric performance study (like an AI study would entail) was conducted or presented in this 510(k) submission.

Summary of what can be extracted regarding "acceptance criteria" and "study" for this physical device:

• Acceptance Criteria and Reported Device Performance (Table): Not directly available in a table format for performance in the AI sense. The text mentions "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." The types of non-clinical tests that presumably had acceptance criteria are listed:
  • Visual & Dimensional Inspections
  • Guidewire Compatibility
  • Tensile testing
  • Test Conical Fittings with 6% Luer taper
  • (No specific performance metrics are given, only that criteria were met).
• Sample size for the test set and data provenance: N/A for an AI/algorithm study. The "test set" here refers to the physical devices manufactured for non-clinical testing, not a dataset of patient images.
• Number of experts used to establish ground truth & qualifications: N/A. Ground truth for these physical tests would be engineering specifications and measurements.
• Adjudication method: N/A.
• MRMC comparative effectiveness study: No. "Clinical testing was not required."
• Standalone (algorithm only without human-in-the-loop performance): No, this is for a physical medical device.
• Type of ground truth used: For the physical device, ground truth would be engineering specifications, material standards, and physical measurements.
• Sample size for the training set: N/A.
• How the ground truth for the training set was established: N/A.

Ask a specific question about this device