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The intended use of the Philips Patient Information Center iX software application is to:

• Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than ● at the patient, for multiple patients.
• . Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
  • Algorithms present in the software are limited to the ST/AR ECG (for arthythmia, ST Segment and QT Segment — Monitoring) and SpO2.
• Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
• Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
• Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
• Provide connection to other systems not associated with active patient monitoring, such as information systems. The software ● performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.

The Information Center Software is intended for use in professional healthcare professionals. The Information Center Software is not intended for home use.

Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.

Rx only.

The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database.

Additionally, the M3290B Patient Information Center iX software Release C.03 provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Compatible Accessories include: Mobile Caregiver - a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate device.

The provided text describes the Philips M3290B Patient Information Center iX Release C.03 and its substantial equivalence to a predicate device. However, it explicitly states that no clinical performance testing was performed for the new device. Therefore, the specific information requested regarding acceptance criteria, reported device performance metrics, sample sizes, expert qualifications, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document primarily focuses on non-clinical performance and a comparison of technical characteristics with the predicate device to argue for substantial equivalence.

Here's the breakdown based on the information provided and not provided in the document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated with quantifiable metrics for clinical performance. The document mentions "Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed." This suggests internal performance and functionality goals were met, but specific clinical acceptance criteria are not detailed.
• Reported Device Performance: Not reported as no clinical performance testing was done.

2. Sample sized used for the test set and the data provenance:

• Not provided. No clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. No clinical test set requiring expert ground truth was used.

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

• Not provided. No clinical test set requiring adjudication was used.

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:

• No, an MRMC study was NOT done. The document states: "Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."

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

• While the device includes algorithms (ST/AR ECG for arrhythmia, ST Segment and QT Segment Monitoring, and SpO2), the document does not detail any standalone performance studies for these algorithms. Its focus is on the overall "Patient Information Center iX software application" and its substantial equivalence to the predicate. The changes primarily relate to a user-adjustable QRS detection threshold, which was a feature already cleared on another Philips product (K014261).

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

• Not provided for clinical performance. For internal verification and validation, the ground truth would typically be based on product specifications and risk analysis, but this is not clinical ground truth.

8. The sample size for the training set:

• Not applicable/Not provided. As no new clinical performance testing was performed, details about training sets for algorithms are not discussed in this document.

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

• Not applicable/Not provided.

Summary of Device Changes and Justification for No Clinical Study:

The primary change in the M3290B Patient Information Center iX Release C.03 compared to its predicate (Release C.01) is the addition of a user-adjustable minimum QRS detection threshold. This feature was previously cleared on Philips ST/AR, ST and Arrhythmia Algorithm Software (K014261). The manufacturer argues that this, along with other non-significant changes (such as system scalability increases, cybersecurity improvements, and OS updates), does not introduce new clinical features or risks that would necessitate new clinical performance testing. Therefore, "Clinical Performance testing... was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."

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