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Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for:

Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;

Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).

Firefighter™ NC Pro PTCA Balloon Catheter is a rapid exchange catheter, with a non-compliant balloon near the distal tip. Two radiopaque marker bands are located underneath the balloon and fixed on the inner lumen to position the balloon. The hydrophilic coating is located on the whole distal section to reduce friction and enhance the crossing capability. The effective length of the catheter is 145cm, the inner lumen of catheter permits the use of guide wire ≤ 0.014 inch (0.36mm). Firefighter™ NC Pro is available with balloon diameters of 2.00-5.50mm and balloon lengths of 6, 10, 15, 20, 25 and 30mm. 5F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 2.00-4.00mm balloon diameter. 6F Guiding catheter is used for the delivery of Firefighter™ NC Pro with 4.50-5.50mm balloon diameter.

The provided document does not describe an AI/ML powered device. It details the 510(k) premarket notification for the "Firefighter™ NC Pro PTCA Balloon Catheter", which is a traditional medical device (a balloon catheter for angioplasty).

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/ML device, as this document is not about such a device. The questions about test sets, data provenance, expert adjudication, MRMC studies, standalone performance, training sets, and ground truth establishment for a machine learning model are not applicable to the information contained within these pages.

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