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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, MP5, MP5T, MP5SC, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models MP2, X2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 Patient Monitors which consist of display units IntelliVue including build-in or separate flat panel displays and central processing units as well as physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each. The Patient Monitor family is a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions to the IntelliVue family plug-in measurement modules. The and monitors can also be connected to the IntelliVue anesthetic gas modules and to the IntelliVue TcG10 Measurement Module.

The subject modification is the introduction of the Integrated Pulmonary Index (IPI) software module as an extension to the legally marketed Microstream CO2 measurement module as integrated or interfaced to the Patient Monitor family.

The IPI is a numerical integer value ranging from 1 to 10. It is calculated based on the four major parameters from the monitoring of the physiological parameters CO2 and SpO2 in order to provide a simple and clear single parameter indication of the patient's ventilation status. These four major parameters are etCO2 and Respiration Rate (RR) which are received from the Microstream CO2 measurement module, as well as SpO2 and Pulse Rate (PR) which are received from the pulse oximetry module of the host system.

The Philips MP2, X2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700, and MX800 IntelliVue Patient Monitors, with the Integrated Pulmonary Index (IPI) software module, underwent verification and validation testing to establish their safety, performance, functionality, and reliability.

1. Acceptance Criteria and Reported Device Performance:

The provided document states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices." However, the specific quantitative acceptance criteria for the IPI software module or the overall patient monitor performance are not explicitly detailed in the provided text. The document concludes: "The results demonstrate that the modified Philips MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 IntelliVue Patient Monitors are as safe and as effective and perform as the predicate devices."

Therefore, based on the provided text, the table is as follows:

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

This information is not provided in the document. The text mentions "Verification and validation testing activities were conducted," but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts and their Qualifications for Ground Truth of the Test Set:

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study is not mentioned in the document. The study described focuses on the comparison of the modified device to predicate devices in terms of safety and effectiveness, rather than evaluating human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study of the IPI algorithm without human-in-the-loop is not explicitly detailed as a separate study. The IPI is described as a software module that provides a simple indication of ventilation status based on physiological parameters. The V&V testing would inherently involve evaluating the IPI's calculations and output, which could be considered a form of standalone evaluation of its functionality. However, a dedicated 'standalone performance study' with specific metrics for the IPI algorithm's accuracy in isolation is not described.

7. Type of Ground Truth Used:

The document states that the IPI calculation is based on "four major parameters from the monitoring of the physiological parameters CO2 and SpO2," specifically "etCO2 and Respiration Rate (RR) which are received from the Microstream CO2 measurement module, as well as SpO2 and Pulse Rate (PR) which are received from the pulse oximetry module of the host system." This suggests that the ground truth for evaluating the IPI's calculation would be derived from the measurements of these established physiological parameters from the integrated modules. It does not mention expert consensus, pathology, or outcomes data as direct ground truth for the IPI itself, but rather the accurate processing of existing physiological data.

8. Sample Size for the Training Set:

This information is not provided in the document. The document refers to the IPI as a "software module" and its calculation, but does not describe it as a machine learning or AI model that requires a distinct training set in the conventional sense.

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

As the document does not describe a distinct training set, this information is not applicable/provided. The IPI appears to be a deterministic calculation based on established physiological parameters rather than a learned model.

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