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The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.

The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.

The provided text is a 510(k) clearance letter from the FDA for a medical device: the "White River Automatic Breast Pump, Model 2000 Intermittent Wall Suction Breast Pump Regulator."

This document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter states that the device has been reviewed and determined to be "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence determination means that the FDA found the device to be as safe and effective as a legally marketed predicate device.

To provide the requested information, such as acceptance criteria, performance data, sample sizes, ground truth establishment, or details about comparative effectiveness studies, you would need to refer to the actual 510(k) submission document (K964679) itself, which is not provided here. The 510(k) clearance letter is merely the FDA's formal decision, not the full submission detailing the testing and performance of the device.

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