(116 days)
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.
All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and the hydrophilic coating of the braided shaft will become optional. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.
The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
The provided text describes a medical device named "Chocolate PTA Balloon Catheter" and its regulatory clearance (510(k)). However, it does not contain information related to software, artificial intelligence, or diagnostic performance metrics that would be relevant to acceptance criteria for such systems.
Specifically, the document focuses on the substantial equivalence of a physical medical device (a balloon catheter) to existing predicate devices. The performance data section refers to "Bench testing" and "in vitro tests" like "Peak friction force in an established peripheral model" to demonstrate reliable physical performance and safety for its intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to AI/software performance for this specific document. The questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not applicable to the information presented.
§ 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).