(87 days)
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:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or the nature of any test sets.
- Information on experts, ground truth establishment, or adjudication methods for test sets.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Information about a standalone algorithm performance.
- The type of ground truth used.
- 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.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).