(182 days)
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The OS System serves as a decision support tool as well as an electronic medical record.
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The OS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware.
This document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.
Instead, the provided text is a 510(k) summary for the Quantitative Sentinel System 7.0, describing its intended use, comparison to predicate devices, and asserting that no clinical testing was necessary to demonstrate conformity to performance requirements.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment.
§ 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).