Search Results

The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. Passeo-35 is also recommended for post-dilatation of balloon expanding stents in the peripheral vasculature.

BIOTRONIK's Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo Catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035″ to facilitate advancement of the Passeo 35 Xeo Catheter towards and through the lesion(s) to be dilated.

This is information on a medical device, not AI/ML. The provided text is a 510(k) premarket notification for the "Passeo-35 Xeo Peripheral Dilatation Catheter." It describes the device, its indications for use, and a comparison to a predicate device. The information requested in the prompt, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth, is typically relevant for studies evaluating the performance of AI/ML-driven medical devices, especially for diagnostic or prognostic purposes.

Since the document provided is for a physical medical device (a catheter), these AI/ML-centric questions are not applicable. The performance data section focuses on bench testing of physical characteristics and safety, not on evaluating an algorithm's performance.

Therefore, I cannot provide the requested information as the document does not pertain to an AI/ML device.

Ask a specific question about this device