(135 days)
The Ebony HP PTA OTW 0.035" Catheter is indicated for;
· Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
· Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Ebony HP PTA OTW 0.035" Catheter is a standard Over The Wire (OTW) PTA catheter with a non-compliant inflatable balloon at the distal part with an atraumatic, tapered tip at its distal end to facilitate advancement of the catheter through the stenosis, and a luer lock fitting (Y hub) at the proximal end allowing the connection with an inflation device. The catheter is a two lumen catheter; one lumen is used for inflation of the balloon and accessed via the lateral port of the Y hub. The second lumen, starting at the straight entry port of the Y hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035". The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel. The working pressure range for the balloon is between the nominal pressure (NP) and the rated burst pressure (RBP). A hydrophilic coating solution is applied on the distal section of the shaft and on the balloon to improve the pushability of the catheter by reduction of the friction coefficient of the outer body.
This document describes the premarket notification (510(k)) for the Ebony HP PTA OTW 0.035" Catheter. The information provided outlines the device's characteristics, indications for use, and the performance data that supports its substantial equivalence to predicate devices. However, the document does not contain details regarding a study for an AI/ML powered medical device, particularly with the specific criteria asked for in your prompt (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment).
Therefore, I cannot extract the information required to populate the fields related to an AI/ML study from the given text. The document focuses on the non-clinical performance testing of a physical medical device (a catheter) and its biocompatibility, mechanical properties, and compliance with standards.
To directly answer your request based on the provided text, the device in question is a physical medical device, not an AI/ML powered one. Thus, the concepts of acceptance criteria for AI performance, training/test sets, expert ground truth establishment for AI, MRMC studies, or standalone algorithm performance are not applicable to this document.
§ 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).