(22 days)
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.
The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.
The provided text describes a 510(k) premarket notification for the PolarCath™ Peripheral Dilatation System, which is a Percutaneous Transluminal Angioplasty Catheter. The document is a regulatory submission, not a study report, and therefore does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.
The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates traditional device testing (bench testing, design controls) was performed, not clinical studies involving AI performance metrics.
Therefore, I cannot provide the requested table and study details as they are not present in the provided document.
This document is from 2004, a period before AI/ML-driven medical devices were commonly evaluated in the same manner as described in your request. The evaluation framework for devices like this involved demonstrating substantial equivalence to a predicate device through engineering design, material specifications, manufacturing processes, and bench testing, rather than through extensive clinical performance studies with AI components.
§ 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).