(254 days)
The Merit Mighty Wire is intended to be used to facilitate the placement of devices during diagnostic and interventional procedures in the central circulatory system, excluding the coronary arteries and neurovasculature.
The wire is composed of a PTFE (polytetrafluoroethylene) coated stainless-steel core wire with a grind profile ending in a flexible distal tip. A PTFE coated stainless steel distal coil is laser-welded to the proximal end of the core wire grind profile and plasma arc-welded to the distal end of the core wire profile. The PTFE coating covers 100% of the guide wire surface. For wire lengths 230, 260, and 300cm, an additional radiopaque Platinum-Tungsten marker coil is welded to the core wire flexible distal tip. The distal tip is radiopaque.
The provided text is a compilation of FDA documents related to the 510(k) clearance of the "Mighty Wire Guide Wire". It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The document is for a physical medical device (guide wire) and outlines the regulatory process for its clearance based on substantial equivalence to a predicate device.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML enabled device from the provided text. The questions pertaining to sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment are not applicable to the content of this document.
§ 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.