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The Electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It is intended for a single user.

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I am sorry, but based on the provided document, I cannot answer your request. The document is a letter from the FDA regarding a 510(k) premarket notification for an "Electric breast pump." It discusses regulatory aspects, general controls, and indications for use.

However, it does not contain any information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), or training set details.

Therefore, I cannot extract the specific information you've requested regarding the study that proves the device meets acceptance criteria.

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