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The Intended Use of the GENTLEFEED DUO BREAST PUMP is to express milk from the breast of lactating women.

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This document is a 510(k) clearance letter from the FDA for a breast pump, "MEBBY GENTLEFEED DUO." It does not contain information about the acceptance criteria for a study, the study itself, device performance results, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The letter's purpose is to inform Medel S.p.A. that their device has been found substantially equivalent to a legally marketed predicate device, allowing them to market it. It discusses regulatory requirements but no performance study data.

Therefore, I cannot fulfill your request using the provided input. The information you're looking for (acceptance criteria, study details, performance data) would typically be found in the 510(k) submission document itself, or in a separate clinical or non-clinical study report, not in the FDA's clearance letter.

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