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The intended use of the Philips Emergin Event Management software provides healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all or 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 Philips Emergin Event Management product is a software only event management product.

The provided documentation for K102974 P1/2, Philips Emergin Event Management, does not contain specific acceptance criteria or detailed study results with performance metrics that can be extracted to populate the requested table directly. The submission states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the device. Testing involved system level and regression tests as well as testing from the hazard analysis. The results demonstrate that the Philips meets all reliability requirements and performance claims." However, it does not quantitatively describe these requirements or claims, nor does it provide a table of observed performance values against them.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for the test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a software for routing alarms, not for diagnostic interpretation requiring expert ground truth for image/signal analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing described appears to be software and system functionality testing, not a clinical study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is an event management system, not an AI-assisted diagnostic tool that aids human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The term "standalone" is not used in the context of diagnostic algorithms here. The device is a software application. The testing performed ("system level and regression tests as well as testing from the hazard analysis") evaluates the algorithm/software functionality directly, without a human-in-the-loop performance evaluation in a clinical setting for diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for an alarm routing system would relate to whether alarms are correctly processed and routed according to specifications, not clinical diagnoses. This would typically be assessed through functional testing against predefined system requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm in the context of requiring a "training set" for model development. It is an event management software.

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

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