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The Del Sol Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Del Sol Blue Light Therapy System is generally indicated to treat dermatological conditions. The Del Sol Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

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I am unable to answer your request. The provided text is a 510(k) clearance letter from the FDA for a medical device (Del Sol Blue Light Therapy system).

While this letter confirms that the device is cleared for market based on substantial equivalence to a predicate device, it does not contain the detailed study information, acceptance criteria, or performance data that you are requesting. Such information would typically be found in the actual 510(k) submission document or a summary thereof, which is not provided in the given text.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for test sets.
• Information on MRMC studies or standalone algorithm performance.
• Details about the ground truth used or how it was established for training and test sets.
• Sample size for the training set.

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