(98 days)
The intended use of the CareEvent solution is to provide healthcare professionals with supplemental information about patient alarms, technical alarms and system information messages (events). The product can route all of subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
The CareEvent mobile application software provides healthcare professionals with supplemental information about patient alarms, technical alarms and system information messages (events). Receipt of alarm messages or events by the external mobile device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
The CareEvent solution is designed to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events).
I am sorry, but the provided text does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification letter and a summary for the Philips CareEvent device, which is a system for routing patient alarms and system information.
While it mentions "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate," it does not provide details on:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance. The text only states "Testing involved system level tests, performance tests, and safety testing from hazard analysis."
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study. The device is described as providing "supplemental information" and "not a replacement for alarming devices," which suggests it's not a diagnostic AI.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth was established for the training set.
The document primarily focuses on establishing substantial equivalence to a predicate device (IntelliSphere Event Management K102974) based on similar indications for use, intended use, and technological characteristics, as well as satisfactory performance in general system and safety testing. The pass/fail criteria are explicitly stated as being "based on the specifications cleared for the predicate device," but those specifications are not detailed here.
§ 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).