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The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" outer diameter guidewire. The CanaliZer is not intended for use in the coronary arteries.

The guidewires are constructed from a Nitinol core coated with Tecoflex EG85-A polyurethane to provide a wire with a maximum OD of 0.035" or 0.038". The polyurethane formulation contains BaSO4 for radiopacity. A hydrophilic coating is applied to the distal portion of the guidewire to facilitate wire movement within 0.035" or 0.038" diameter devices. The guidewires are available in lengths of 150, 180 and 260 cm. Two tip shapes are also available, straight and angled. Both tip shapes are provided on wires of standard stiffness, and a stiffer design. The family of guidewires has a CE mark and is in commercial distribution in Europe.

The provided text refers to a premarket notification for a medical device called the "InterV® brand CanaliZer Hydrophilic Guide Wire." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, the requested information regarding acceptance criteria, a study proving performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided text.

The document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on comparing the technological characteristics of the new device to a predicate device, and often includes bench testing to confirm compliance with recognized standards or demonstrate equivalence, but not necessarily a full clinical study with acceptance criteria and reported performance in the way a new drug or a novel high-risk device might.

The relevant sections provided are:

• Premarket Notification [510(K)] Summary: This section describes the device, its intended use, and technological characteristics, and identifies predicate devices.
• FDA Review Letter: This letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to predicate devices for its stated indications for use.
• Indications for Use: This section reiterates the intended use of the device.

In summary, the provided content is for a 510(k) submission, which does not typically include the detailed study information as requested.

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