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The Capture™ LP 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 Capture™ LP device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptoms onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Platinum -Iridium and Platinum-Tungsten radiopaque markers on the proximal and distal ends respectively. The device is supplied sterile and is intended for single-use only by physicians trained in interventional neuroradiology and treatment of ischemic stroke.

I am sorry, but based on the provided document, the device described is not an AI/ML powered device. As such, I cannot provide a response to your request, as it specifically asks for details related to AI/ML powered devices, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance metrics.

The document details the K141516 MindFrame Capture™ LP Revascularization Device, which is a physical thrombus retriever for ischemic stroke. The performance data presented in the document pertains to bench testing (e.g., durability, tensile strength, radial force, clot retrieval in models) and animal studies (usability, effectiveness, safety in swine), not a software or AI/ML-based diagnostic or treatment device.

Therefore, the requested information regarding acceptance criteria, study details, and performance metrics in the context of AI/ML are not available in this document.

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