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The Beamer Painlow Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.

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The provided text is a 510(k) premarket notification approval letter for the "Beamer Painlow Infrared Light Treatment System". It acknowledges that the device is substantially equivalent to a legally marketed predicate device but does not include any study data, acceptance criteria, or performance metrics.

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The document primarily focuses on regulatory approval, stating that the device is substantially equivalent to existing predicate devices for the indicated uses. It does not contain details about:

• Acceptance criteria for device performance
• Reported device performance against any criteria
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used
• How ground truth was established for training data

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