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The Golemb Disposable Bag Mast Resuscitator is a single patient use system for manual resuscitation.

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The provided text is a 510(k) premarket notification approval letter for the "Golemb Disposable Bag Mask Resuscitator." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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. The document is solely an FDA approval stating the device is substantially equivalent to a predicate device.

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