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The Simply Go™ Breast Pump is an electrically operated suction device used to express and collect milk from the breast(s) of lactating woman.

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The provided document is a 510(k) premarket notification letter from the FDA to Evenflo Company, Inc. regarding their SimplyGo™ Hands Free Breast Pump. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on substantial equivalence to a predicate device, not on a standalone performance study with specific acceptance criteria as one might see for a novel, higher-risk device or a device requiring de novo classification.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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