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The Selebrek PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Selebrek PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Dilatation Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Selebrek is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semicompliant balloons are available in diameters of 1.5mm and lengths from 6-30mm, and have a rated burst pressure of 14 atm.

The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters).

The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a quide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated.

The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial quidance and rapid exchange of the catheter with a single standard length guidewire.

One radiopaque Platinum/lridium marker band is located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

The provided document is a 510(k) Summary for a medical device (Selebrek PTCA Balloon Dilatation Catheter). It details the device's comparison to a predicate device and non-clinical testing performed to establish substantial equivalence.

However, the document does NOT contain information about AI/ML device performance or acceptance criteria related to AI/ML. There is no mention of an algorithm, AI assistance, human readers, ground truth establishment for AI, or any of the metrics typically associated with AI/ML model evaluation (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and studies. The document only describes a traditional medical device (balloon catheter) and its non-clinical bench testing for mechanical, physical, and biocompatibility properties.

If you are looking for an example of a 510(k) submission that does include AI/ML performance data, you would need to refer to a different type of device, such as an AI-powered diagnostic imaging tool.

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