Search Results

Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems. ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

The ENVOY and Vista Brite Tip Guiding Catheters are single lumen catheters which features a nylon body reinforced with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheters are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheters' tip, is pellethane with a radiopaque filler, this is the softest material in the catheter.

This looks like a 510(k) premarket notification for a medical device (Cordis Guiding Catheters) and not a study describing a device that uses AI or machine learning. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML performance evaluations, are not present in the provided text.

The provided text focuses on:

• General Provisions: Common and proprietary names, predicate devices, classification, and lack of established performance standards.
• Indication For Use and Device Description: Explaining what the catheters are used for and their physical characteristics.
• Biocompatibility: Stating that tests were successfully completed.
• Summary of Substantial Equivalence: Claiming similarity to existing devices.
• Proposed Labeling: Discussing package labels, instructions for use, and intended use statements.

Conclusion:

Based on the provided document, I cannot extract the information required to populate the table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML. This document pertains to a traditional medical device submission (catheters) where performance is likely demonstrated through substantial equivalence to predicate devices and adherence to manufacturing and materials standards, rather than through complex performance metrics against a defined ground truth as would be the case for an AI algorithm.

Ask a specific question about this device