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For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use.

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The provided document is a 510(k) premarket notification letter from the FDA regarding the "Ethanol-L3K Assay." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way you've requested for an AI/ML medical device.

The information you are asking for typically comes from the actual 510(k) submission document itself, or from a scientific publication detailing the device's validation. This FDA letter is merely the agency's response granting market clearance.

Therefore, I cannot fulfill your request for the specific details outlined as they are not present in the provided text.

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