(146 days)
The indications for use of the BeneVision Central Monitoring System include:
- Real time viewing of patient clinical data and alarms .
- . Storage and Historical review of patient clinical data and alarms
- Printing of real time and historical patient data
- Configuration of local settings as well as synchronizing settings across the network to a remote device
- Transfer of patient clinical data and settings between several CentralStations
- Provides a Resting 12 Lead interpretation of previously stored data
The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors.
The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80 and TM70.
The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, . SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
. The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG. SpO2. NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.
The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.
The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.
The provided text is a 510(k) premarket notification summary for the BeneVision Central Monitoring System. It details the device, its intended use, comparison to predicate devices, and various testing performed to demonstrate substantial equivalence.
However, the document does not contain information about an AI/algorithm where acceptance criteria and specific performance metrics (like sensitivity, specificity, or AUC) or information related to multi-reader multi-case (MRMC) comparative effectiveness studies would typically be found. The changes describe modifications to the software for an existing central monitoring system, primarily related to operating system compatibility, supported monitors, and the addition of a "Resting 12 Lead interpretation of previously stored data" feature.
The document discusses "Software Verification and Validation Testing" and "Bench Testing" to ensure the device meets its specifications, but these tests are for the overall system's functionality and accuracy, not for an AI component that would require the level of detail requested in the prompt.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance for an AI model, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device, as this information is not present in the provided text.
The information that is available in the document regarding testing is general:
- Software Verification and Validation Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This ensures the product "works as designed" and validates its "design and performance."
- Bench Testing: Conducted "functional and system level testing to validate the performance of the devices." The results "show that the subject device meets its accuracy specification, and is substantially equivalent to the predicate device."
- Consensus Standards: The device meets relevant consensus standards, specifically mentioning IEC 60601-2-25:2011 for electrocardiographs.
The document explicitly states:
- Animal Testing: "Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."
- Clinical Data: "Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device."
Without an AI/ML component described with specific performance criteria and a study demonstrating its meeting those criteria, the detailed information requested in the prompt cannot be extracted from this document.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).