(86 days)
The PowerFlex Plus PTA balloon catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Cordis PowerFlex Plus PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 450 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon.
The provided text does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of AI/ML medical devices. This document is a 510(k) Premarket Notification for a PTA Balloon Catheter from 1997, focusing on demonstrating substantial equivalence to predicate devices rather than novel performance claims supported by clinical studies with specific acceptance criteria.
Therefore, I cannot populate the requested table or answer the questions related to test sets, ground truth establishment, expert adjudication, or MRMC studies.
Here's why this information is absent in your input:
- Device Type: This document is for a physical medical device (a balloon catheter), not a software or AI/ML device that would typically have performance metrics like accuracy, sensitivity, specificity, and require a test set with established ground truth.
- Regulatory Pathway: A 510(k) is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, and intended use, and may include some bench testing or limited clinical data if necessary to support equivalence, rather than a full-scale performance study with predefined acceptance criteria for AI output.
- Date: The document is from 1997, predating the widespread use of AI/ML in medical devices and the associated regulatory expectations and study designs.
If you have a different document related to an AI/ML medical device, I would be happy to analyze it for the requested information.
§ 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).