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CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.

WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.

CALM Patterns is a computerized method to detect, label and measure features in the fetal monitor recording. CALM Patterns uses fetal monitor data imported through an interface with an external source as described in a previous submission (K980719) or with a third-party clinical information system. CALM Patterns can function in a networked environment or as a standalone workstation.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the CALM Patterns device, discussing its substantial equivalence to a predicate device (OB TraceVue).

Therefore, I cannot provide the requested information. The document focuses on comparing the features of CALM Patterns to OB TraceVue for substantial equivalence, rather than presenting a performance study with acceptance criteria.

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