(117 days)
The Modified Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail TV t-PA therapy are candidates for treatment. The Modified Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Like the predicate device, the Modified Merci Retriever consists of a flexible, Nitinol core wire with shaped loops at the distal end. A radiopaque coil covers the tip allowing visualization under fluoroscopy.
The Retriever is placed distal to the thrombus or foreign body through a microcatheter. The Retriever and microcatheter are pulled back to engage the thrombus or foreign body in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcatheter are then removed from the body.
The provided text describes a 510(k) premarket notification for the "Modified Merci Retriever" device. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving the device meets specific criteria.
The document states:
- "All devices met the required specifications for the completed tests." within the "Testing Summary" section.
- "The Modified Merci Retriever is substantially equivalent to the predicate device. The indications for use, function, and materials used are equivalent." in the "Summary of Substantial Equivalence" section.
This indicates that internal testing was performed, and the device met its internal specifications. However, the document does not provide details about what those specifications (acceptance criteria) were, what the "reported device performance" was, or the methodology of any studies conducted to demonstrate this.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies, as this information is not present in the provided text.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Merci Retriever) based on similar indications for use, function, and materials. It does not include a detailed scientific study report with the specific information you are requesting.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).