(24 days)
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 perfusion;
b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment 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 Catheter is a rapid exchange co-axial design with a balloon at the distal tip. Balloon diameters from 1.50 mm through 3.25 mm use a single layer design and balloon diameters from 3.50 mm through 5.00 mm use a co-extruded design for both predicate and new sizes. 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 to the guide wire notch junction, along with brachial and femoral markers.
The provided text describes a 510(k) premarket notification for the NC TREK™ RX Coronary Dilatation Catheter, a medical device. The document focuses on demonstrating substantial equivalence to a predicate device through in vitro bench testing and biocompatibility testing. It provides detailed information on the performance data but does not contain any information about an AI/ML device or its acceptance criteria or studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI/ML device meets them, as the provided text pertains to a conventional medical device (a coronary dilatation catheter) and its mechanical and physical properties, not software or AI/ML performance.
The information requested in your prompt (sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established) is typically relevant for AI/ML device evaluations and is not found in this document.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.