(50 days)
The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.
The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a rapid exchange balloon catheter for peripheral indications with a working length of 150cm. The minimally compliant balloons, available in diameters from 1.5-6.0mm and lengths from 15-120mm, can be inflated by injecting dilute contrast media solution through the trailing hub of the catheter. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atm (Ø1.5-4.0mm) or 18atm (Ø4.5-6.0mm). Hydrophilic lubricious coatings are applied to the distal section of the catheter. The proximal shaft of the catheter is composed of a female luer connector bonded to a nylon tube which is internally supported by a stainless steel hypotube. Two radiopaque platinum/iridium marker bands are located within the balloon shoulders. The internal lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the RX port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 3mm in length located on the proximal shaft specifically designed to be highly visible, indicate catheter position relative to the guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
The provided text is a 510(k) Summary for the Jade PTA Balloon Dilatation Catheter. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm or its performance with human readers. The information provided is for a physical medical device (a balloon catheter), not an AI/ML diagnostic or assistive tool.
Therefore, I cannot fulfill your request as the necessary information regarding AI/ML acceptance criteria, human reader studies, ground truth establishment for AI/ML, sample sizes for training/test sets for AI/ML, or expert qualifications for AI/ML ground truth is not present in the provided document.
The "Performance Data" section in the document refers to in vitro performance tests and biocompatibility tests for the physical catheter, not an AI/ML system.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).