Search Results

The NC TREK™ RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perforusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segement elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

The NC TREK RX Coronary Dilatation Catheters is a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.

The provided text describes a medical device, the NC TREK™ RX Coronary Dilatation Catheter, and its clearance process. However, it does not include information relevant to an AI/ML device and its associated studies (e.g., test set, training set, ground truth, expert adjudication, MRMC studies).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them in an AI/ML context from this document.

The document discusses in vitro bench and biocompatibility tests conducted according to specific guidance for Class II medical devices, and these tests demonstrated that the device "met all acceptance criteria and performed similarly to the predicate devices." This implies the acceptance criteria were related to the physical and biological performance characteristics of the catheter, not diagnostic accuracy or output from an AI model.

The questions you asked are highly geared towards AI/ML device evaluations. Since the provided document is for a physical medical device (coronary dilatation catheter) and not an AI/ML diagnostic or assistive tool, the requested information is not present.

Ask a specific question about this device