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The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional's end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use.

Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips CareEvent provides confirmed delivery features when it is used with the Philips CareEvent mobile application on Philips-approved devices. The Philips CareEvent mobile application either communicates alarm information that is sent from the Philips CareEvent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.

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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).

The provided document is a 510(k) summary for the Philips CareEvent device, which is a software application intended to deliver supplemental medical device data. The key points regarding acceptance criteria and the study are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table of acceptance criteria with numerical targets and reported device performance. Instead, it states that:

"Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The Philips CareEvent software application Release B.01 meets all defined reliability requirements and performance claims."

This indicates that the acceptance criteria were implicitly the specifications of the predicate device (CareEvent, K142935) and that the new device met those criteria, thereby demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a numerical sample size for any test set. It broadly refers to "system level tests, performance tests, and safety testing from hazard analysis."
• Data Provenance: Not specified. There is no mention of country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The ground truth for this type of software device (a communication system for physiological alarms) is typically established through functional verification and validation against specified requirements, rather than expert judgment on clinical data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the validation focuses on functional and performance specifications rather than clinical interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No. This type of study is not relevant for the Philips CareEvent device, which is a communication system and not an AI-powered diagnostic or interpretive tool that assists human readers in making clinical decisions on medical images or signals.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "performance data" described are non-clinical testing results, which are essentially standalone evaluations of the software's functionality, reliability, and safety against its specifications. The document states:

"The Philips CareEvent software Release B.01 was tested in accordance with Philips verification and validation processes."

7. The Type of Ground Truth Used:

The "ground truth" for this device's validation is based on:

• Predicate Device Specifications: The "Pass/Fail criteria were based on the specifications cleared for the predicate device."
• System Specifications and Requirements: Implicitly, the design and functional requirements of the CareEvent software itself, which incorporate aspects like alarm delivery, notification types, and communication protocols.

8. The Sample Size for the Training Set:

Not applicable. This device is described as a "software application" for a communication system, not a machine learning or AI model that requires a training set of data. Its functionality is based on predefined logic and protocols.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of software device.

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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.

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