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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.

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