(28 days)
The 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 IV t-PA therapy are candidates for treatment. The 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 design of the modified Merci Retriever consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filiaments are attached to the distal end. The core wire proximal to the helix is coated with a fordrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcatheter during the procedure.
I am sorry, but the provided text does not contain information about acceptance criteria and the results of a study as you requested. The document describes a 510(k) submission for a modified Merci Retriever device, focusing on its substantial equivalence to a predicate device. It briefly mentions "design verification and validation testing" confirming conformity to "required specifications," but it does not detail these specifications as acceptance criteria or present specific outcomes of a study that would demonstrate the device meets them.
Therefore, I cannot populate the table or provide answers to the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
§ 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).