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MR4 Laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

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The provided FDA letter (K171354) is a 510(k) clearance for a medical device called the "MR4 Laser." This type of letter generally confirms substantial equivalence to a predicate device and does not describe the detailed clinical study results or acceptance criteria used to prove the performance of the device itself. Instead, it relies on the predicate device's established safety and effectiveness.

Therefore, none of the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be extracted from this document.

This document primarily focuses on:

• Device Name: MR4 Laser
• Regulation Number/Name: 21 CFR 890.5500, Infrared Lamp
• Regulatory Class: Class II
• Product Code: NHN
• Indications for Use: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
• Regulatory Status: Substantially Equivalent to legally marketed predicate devices.

To get the information you are requesting, one would typically need to review the full 510(k) submission itself, which contains the detailed technical and performance data that led to this clearance. The FDA letter is merely the conclusion of their review of that submission.

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