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The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.

SUILE Ointment Wound Dressing

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing the acceptance criteria and performance of a device based on a specific study.

Therefore, I cannot extract the information required to answer your questions as it is not present in the provided text. The document is primarily about regulatory approval and does not contain details regarding:

• Acceptance criteria and reported device performance in a table format.
• Sample size or data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance of an algorithm.
• Type of ground truth used.
• Sample size for a training set.
• Method for establishing ground truth for a training set.

This document confirms that the SUILE Ointment Wound Dressing is "substantially equivalent" to legally marketed predicate devices for the indicated uses, but it does not provide the detailed study results you are asking for.

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