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This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby's heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple "button holes" for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing.

The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one blue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.

I am sorry, but the provided text does not contain the information required to answer your request. The documents are a FDA 510(k) clearance letter and an Indications For Use statement for "Securline® Umbilical Disposable Fetal Monitoring Abdominal Straps". These documents confirm that the device is substantially equivalent to a predicate device and describe its intended use, but they do not disclose any detailed study information such as acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications, which would be typical for a clinical study report.

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