(129 days)
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.
The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
The provided document does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device called the "Tigertriever 13 Revascularization Device," which is a stentriever used to remove thrombus in ischemic stroke patients. This type of device is a physical medical instrument, not an AI/ML software.
The document discusses non-clinical performance data, including biocompatibility, sterilization, shelf life, and various bench tests for the Tigertriever 13 Revascularization Device. It also mentions pre-clinical animal testing.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on the given input.
§ 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).