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The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

The D·Kutting™ PTA Scoring Balloon Dilatation Catheter is an Over-The-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.018" or 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with Luer lock fillings. 3 scoring wires between the two marker bands are radially distributed every 120° and mounted on the surface of the balloon. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D. Kutting™ PTA Scoring Balloon Dilatation Catheter will be available with balloon diameters 4.0 mm to 8.0 mm, balloon lengths 20 mm to 80 mm and with catheter lengths of 50 cm, 90 cm, and 130 cm. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub.

The provided document is a 510(k) summary for the D.Kutting™ PTA Scoring Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance, biocompatibility, sterility, and animal studies. However, the document does not describe a study involving an AI/Machine Learning (ML) component, nor does it provide acceptance criteria and performance data in the context of AI/ML.

Therefore, I cannot extract the information requested for an AI/ML device from this document. The document primarily concerns the safety and effectiveness of a physical medical device (a balloon dilatation catheter) and its equivalence to a similar, previously cleared device.

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