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The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

MR Fiber Optic Intubating Laryngoscope Handle, Short

The provided text is a 510(k) summary for the "MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short." This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance is not available in the provided text.

The document primarily states:

• The device's intended use: to facilitate and aid in tracheal intubation in an MRI or interventional MR environment (not exceeding 3.0 Tesla).
• Its classification: Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW).
• Predicate devices it is substantially equivalent to: MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle (K041852), Welch Allyn Laryngoscope, and Sun Med Laryngoscope.
• The assertion that it "raises no new issues of safety or effectiveness" due to its similar technological characteristics to predicate devices.

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