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Powered Breast Pump used to express milk from lactating women

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The provided text is a 510(k) premarket notification letter from the FDA for a breast pump, "Dr. Brown's Natural Flow Double Electric Breast Pump." It confirms the device's substantial equivalence to a legally marketed predicate device.

This document does not contain information regarding the acceptance criteria for performance, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types or establishment for training/test sets). It is a regulatory approval letter based on substantial equivalence, not a medical device performance study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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