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NaviCare® WatchChild™ is indicated for use in a hospital/clinical environment. NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the NaviCare® WatchChild™ Obstetrical Data Management System, which primarily confirms substantial equivalence to a predicate device and outlines regulatory compliance. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

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