(65 days)
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
ANGIODYNAMICS Soft-Vu and ANGIODYNAMICS Mariner Hydrophilic Coated Catheters
The provided text is a 510(k) summary for the AngioDynamics Soft-Vu and AngioDynamics Mariner Hydrophilic Coated Catheters. This document is a regulatory clearance, not a study report detailing acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC study results cannot be found in the provided text.
The document only states that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence is typically based on design, materials, and intended use, and does not generally involve a detailed performance study against specific acceptance criteria in the way a clinical trial or algorithm validation would.
In summary, the input text does not contain the information needed to answer the prompt.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).