(283 days)
The SAVe™ Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. SAVe Resuscitator is intended for patients with a body mass of more than 15kg (~33 lbs), approx. 3 years of age.
The SAVe™ Manual Resuscitator is a hand operated resuscitator that provides control of the volume of delivered ventilation gas (air or oxygenenriched gas).
I apologize, but the provided text only contains a 510(k) summary for the SAVe™ Resuscitator and an FDA clearance letter. It does not include any information regarding acceptance criteria or a study that proves the device meets such criteria.
The document focuses on:
- Submitting information (company details, contact).
- Device information (trade name, common name, classification, product code).
- Predicate information (comparison to existing devices).
- A brief description of the device and its key differentiator (adjustable volume control).
- Indications for Use.
- A summary of technological characteristics compared to predicates, noting substantial equivalence in many aspects.
- The FDA clearance letter for the device.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies, as this information is not present in the provided text.
§ 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).