(28 days)
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Intended to treat because is also intended for post-dilatation of balloonexpandable peripheral vascular stents.
The ATB™ Advance PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac. renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 or 6.0 French nylon tubing compatible with an 0.035-inch quidewire. It will be supplied sterile, intended for one-time use.
The provided text describes a 510(k) Pre-market Notification for the ATB™ Advance PTA Dilatation Catheter. It outlines the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria from an AI/ML perspective.
The "Test Data" section lists various in-vitro tests conducted on the device, inherently mechanical in nature. These are standard engineering tests for medical devices, not studies of an AI's performance.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, statistical performance metrics, sample sizes for AI training/testing, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not present in the provided document.
The document describes a traditional medical device submission for a physical catheter, not an AI or software as a medical device.
What the document does provide in relation to "tests":
The ATB™ Advance PTA Dilatation Catheter was subjected to the following physical/mechanical tests to assure reliable design and performance:
- Tensile tests
- Balloon inflation/deflation tests
- Balloon burst tests
- Balloon compliance
- Balloon fatigue tests
- Balloon profile
- Balloon burst within a stent
- Balloon fatigue within a stent
The document states: "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." However, specific numerical acceptance criteria for each of these tests and their corresponding reported performance values are not detailed in the provided text.
§ 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).