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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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The International Respiratory Systems, Inc's Manual Resuscitator is designed to provide The International respence of reversible apnea, commonly associated with cardiopulmonary arrest.

International Respiratory Systems, Inc.'s Manual Resuscitator

I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Manual Pulmonary Resuscitator. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about:

• Acceptance criteria and reported device performance in a table format.
• Details of a study proving the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device