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The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation in pre-hospital and alternative site arenas.

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This is an FDA Premarket Notification (510(k)) K970158 for the BabyPac device, which is a pneumatically powered ventilator. The document primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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