Search Results

The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

Ask a specific question about this device