(28 days)
The AlarmView™ Wireless Data Network System is for use in real-time monitoring of routine patient status and alarm events on medical devices. It serves as a parallel, redundant mechanism to inform the clinical staff of patient events. The AlarmView™ System provides a secondary means of annunciating and displaying patient alarm information to mobile healthcare professionals.
The AlarmView™ System is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use in hospital type environments and is not for home use.
The AlarmView™ System is to supplement and not replace any part of the current device monitoring procedure.
The AlarmView™ System is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care.
The modified AlarmView™ Wireless Data Network System is a low powered local area wireless paging system that provides secondary annunciation of primary medical device alarms via wireless communication devices carried by healthcare professionals.
The provided text (K013156) is a 510(k) summary for a device modification, and it describes a device that provides secondary annunciation of primary medical device alarms via wireless communication devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies to establish specific acceptance criteria for diagnostic accuracy or clinical outcomes.
Therefore, the provided document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor does it describe specific studies with sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC or standalone) in the context of diagnostic or clinical outcome performance.
The document states:
- "The safety and effectiveness of the modified AlarmView™ Wireless Data Network System described in this submission has been demonstrated through risk analysis and verification and validation testing."
- "Test results demonstrated that the modified AlarmView™ Wireless Data Network System, functionality and safety characteristics are substantially equivalent to the predicate device."
This indicates that the "study" for this submission was primarily focused on engineering verification and validation testing to ensure the modified device functions as intended and maintains the safety and effectiveness profile of its predicate. It's not a study designed to evaluate, for example, the diagnostic accuracy of an AI algorithm or the improvement in human clinical decision-making.
Given this, I cannot extract the information required for the requested table and study details from the provided text because it doesn't exist within the scope of this 510(k) summary.
§ 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).