(15 days)
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.
Not Found
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:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.