(98 days)
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.038inch quidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature, facilitate introduction of diagnostic agents in the neuro vasculature, and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER), The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-the-shelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The provided text discusses the RIST Radial Access Catheter (K201682) and its substantial equivalence to predicate devices, primarily focusing on performance testing. However, it does not contain information related to an AI/ML device. The document is a 510(k) summary for a physical medical device (catheter) and the performance data presented pertains to physical properties, mechanical tests, and biocompatibility, not AI model performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set data) are specific to the evaluation of AI/ML models, which are not applicable to the RIST Radial Access Catheter described here.
§ 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).