(26 days)
The Micro Guide Catheter XP accessory is to be used with the Frontrunner® XP CTO Catheter. The Frontrunner XP CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond the stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.
The Micro Guide Catheter XP is a single lumen, braided guide catheter with a PTFE liner. The Micro Guide Catheter has a 4.5 French profile, an inner diameter of 0.042" and overall lengths of 82 cm and 132 cm.
The Micro Guide Catheter XP is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.
The provided text is related to a 510(k) submission for a medical device called the "Micro Guide Catheter XP." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical in-vitro bench testing and biocompatibility testing. It does not involve a study to establish performance against specific acceptance criteria in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which is what your questions are geared towards.
Therefore, I cannot extract the information you requested about acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, or MRMC studies, as these aspects are not present in the provided 510(k) summary for this type of medical device.
The document states:
- Summary of Testing and Conclusion: "The Micro Guide Catheter XP is substantially equivalent to the predicate devices. The substantial equivalence to the predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing."
- Biocompatibility testing: "Biocompatibility testing was conducted per ISO 10993-1 (2003)(E): 'Biological Evaluation of Medical Devices. Part 1: Evaluation and Testing'."
These types of tests are physical or chemical evaluations of the device itself, rather than studies assessing diagnostic or prognostic performance with human input or an algorithm.
§ 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).