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The International Respiratory Systems, Inc's Manual Resusciated to provide I he international Respuatory BystonEs, Ino of reasoned as a commonly associated with cardiopulmonary arrest.

Manual Pulmonary Resuscitator

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a "Manual Pulmonary Resuscitator," dated July 6, 1998. It confirms the device's substantial equivalence to a legally marketed predicate device but does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or the nature of any test sets.
3. Information on experts, ground truth establishment, or adjudication methods for test sets.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
5. Information about a standalone algorithm performance.
6. The type of ground truth used.
7. The sample size or ground truth establishment for a training set.

The document primarily focuses on the regulatory aspects of device clearance based on substantial equivalence, rather than detailed performance study results.

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