(93 days)
The Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel - excluding use in coronary arteries and in the neurovasculature.
This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA
The provided text is a 510(k) summary for the Rocket Medical plc IR™ Guidewires, dated November 2, 2004. This document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based diagnostic or assistive device.
Instead, it pertains to a physical medical device (guidewires) and focuses on demonstrating substantial equivalence to a predicate device already on the market.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are relevant to the evaluation of AI/machine learning devices, not a traditional physical medical device like guidewires in this context.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.