(89 days)
I. Fetal Surveillance
The Corometrics® Model 171/172 Series Monitors are used for monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). The device also has an optional monitoring mode to detect fetal body movements.
II. Maternal NBP Recording
Blood Pressure. The monitor has an interface to select external NBP monitors. The Monitor does not process any NBP data but only prints the NBP data , from the external monitor, to its chart recorder.
The Model 171/172 Series Fetal Monitor is intended for monitoring fetal and maternal vital signs: fetal heart rate and maternal uterine activity, fetal movement detection, and an interface for select maternal NIBP monitors. The device is intended for use in a hospital/clinical environment.
The provided text is a 510(k) summary for the Corometrics® Model 171/172 Fetal Monitor. It describes the device, its intended use, and comparison to predicate devices. However, it does not contain any information about acceptance criteria, a study proving the device meets acceptance criteria, or any of the specific details requested in your prompt related to the performance study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set, etc.).
The document explicitly states:
- "To date, no performance standards relating to devices of this type have been promulgated by the Food and Drug Administration." This indicates that there are no FDA-mandated performance "acceptance criteria" for this device type.
- "The Model 171/172 Series Fetal Monitor has been extensively tested to meet its requirements and design." While it mentions "extensively tested," it does not provide details of what those requirements were, the results of the tests, or a study demonstrating performance against specific criteria.
Therefore, I cannot populate the table or answer the specific questions about a performance study, as the necessary information is not present in the provided text.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).