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The Bioptron Pro and Bioptron Compact III Light Therapy Systems is indicated for adjunctive use in providing temporary relief of is includied for dejaried shoulder pain of musculoskeletal origin.

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I am sorry, but based on the provided document, the information required to answer your request is not present. This document is a 510(k) clearance letter from the FDA for a light therapy system, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not contain details about:

• Specific acceptance criteria with numerical targets.
• A study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
• Standalone algorithm performance.
• The type of ground truth used.
• Training set details (sample size, ground truth establishment).

Therefore, I cannot fulfill your request for this specific input.

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