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Intended Use:

The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are only for use on one patient at a time.

The monitors are not therapeutic devices.

The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help quide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

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 IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics >5 kg and

All features and technological characteristics of the primary predicate IntelliVue Patient Monitors MX750 (866471), MX850 (866470) and IntelliVue 4-Slot Module Rack FMX-4 (866468) remain unchanged and are still applicable to the IntelliVue Patient Monitors, subject of this submission.

The proposed modifications for the IntelliVue Patient Monitors MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4 include:

• 1. A new software version, designated as IntelliVue Software P.01. The new software version introduces following new features:
  • . New alarm sounds designated as "Philips 2021" sounds, based on a joint development of Philips and Sen Sound researchers who focus on transforming the experience of sound in healthcare.
  • . New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics.
  • . configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel.

It further enhances following existing features

• Manual Selection of QRS /Pulse Tone
• Introduction of Lead Diagram for ECG
• . Enhancement of Visual Presentation for "Global Alarm Off" State

This document describes the Philips IntelliVue Patient Monitor MX750/MX850 and IntelliVue 4-Slot Module Rack FMX-4. The submission references a prior clearance (K221348) as the primary predicate device, indicating that the current submission is for modifications to an existing device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for performance in a table format with numerical values. Instead, it details that the device passed various tests related to electrical safety, EMC, wireless coexistence, software integration, software functionality within the system, essential performance, and human factors. The acceptance criterion for each of these tests is implied to be "PASSED" against recognized consensus standards and internal requirements.

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

The document does not specify the sample sizes used for any of the tests mentioned (e.g., how many devices were tested for electrical safety, or how many users were involved in human factors testing). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of these non-clinical tests.

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

This information is not provided in the document. The tests described are primarily engineering and software validation tests rather than clinical studies requiring expert ground truth for interpretation. For "Human Factors," it would involve users, but their qualifications and numbers are not detailed.

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

This information is not provided. The nature of the tests (compliance with standards, software functionality) suggests that a formal adjudication method like 2+1 or 3+1 for ground truth establishment, typical in clinical studies, would not be applicable here.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a patient monitor with software enhancements, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

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

The document indicates "Software Testing" was performed, which would involve testing the algorithms and functionalities of the software in a standalone manner. However, it's not a standalone diagnostic algorithm in the typical sense; it's the core operating software of the patient monitor. The new features like "new alarm sounds," "Visual Patient feature," and "configurable alarm management" were tested for their functionality and integration.

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

The "ground truth" for the tests described is primarily based on:

• Recognized consensus standards: For electrical safety (IEC 60601-1, IEC 60601-1-8, IEC 62304), EMC (IEC 60601-1-2).
• System requirements/specifications: For software integration, software functionality, and essential performance.
• Usability principles: For Human Factors testing.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth, as these are non-clinical hardware and software validation tests.

8. The sample size for the training set:

This information is not applicable as this document does not describe an AI or machine learning model that requires a training set. The changes described are software updates for existing functionalities and introduction of new display/alarm features, not the development of a predictive algorithm from data.

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

This information is not applicable for the same reason as point 8.

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The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. 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 derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and

The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.

The monitors support multiple non-invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.

The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.

This K221348 510(k) summary document describes the Philips IntelliVue Patient Monitor MX750 and MX850. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of compatibility with external Masimo measurement devices.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., accuracy, precision thresholds) for each physiological parameter measured by the IntelliVue Patient Monitors MX750 and MX850, nor does it provide detailed reported performance values for these criteria in the context of this specific 510(k) submission.

Instead, the document states:

• "Performance specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged" from the predicate devices.
• "performance specifications of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine remain unchanged."

This implies that the acceptance criteria and reported device performance for the core functionalities of the IntelliVue Patient Monitor MX750 and MX850 (excluding the newly added external measurements) are inherently covered by the predicate devices they are compared against. For the newly integrated Masimo modules, their performance criteria and data are derived from their own prior clearances (K162603, K123043, K171121, K172890).

Therefore, a table cannot be directly constructed from this document as it doesn't provide new, specific performance data for the current submission's acceptance criteria beyond referencing existing performance.

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

The document states:

• "Non-clinical Bench Tests: There were no new questions of safety or effectiveness introduced as a result of using this device."
• "Clinical Studies: The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo O3, IRMA CO2, ISA CO2 and SedLine parameters are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor."

This indicates that no new test set (clinical or otherwise) with a specific sample size was used for this 510(k) submission to evaluate the primary IntelliVue devices' performance beyond what was established for their predicates. The assessment relies on the existing validation of the predicate IntelliVue device and the individual Masimo modules.

Therefore, sample sizes for a new test set are not applicable here. The provenance of existing data would refer to the previous submissions for the predicate IntelliVue devices and the Masimo modules, which are not detailed in this document.

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

As no new clinical studies or test sets were conducted for this 510(k) submission to establish new performance data, there is no information provided regarding a number of experts used to establish ground truth or their qualifications. The submission asserts that the performance characteristics (and thus, the ground truth establishment) of the individual components (IntelliVue monitor and Masimo modules) remain unchanged from their prior clearances.

4. Adjudication Method for the Test Set

Since no new test set was generated for this 510(k) submission (as per point 2), no adjudication method specific to this submission's test set is detailed.

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

The document states that "The subject devices, like the primary predicate devices, did not require clinical trials." This implies that no MRMC comparative effectiveness study was performed for this submission. The device is a patient monitor, not typically evaluated with MRMC studies in the way imaging AI algorithms are.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

The document focuses on the integration of external modules into an existing patient monitor. While the individual Masimo modules (O3, IRMA CO2, ISA CO2, SedLine) likely had standalone performance studies as part of their original clearances, this 510(k) document does not report new standalone performance studies for the integrated system or its individual components in this context. The core assertion is that the measurements are not modified, only the host monitor connection.

7. Type of Ground Truth Used

Given that no new studies were conducted, the document implicitly relies on the ground truth established during the previous clearances of the predicate IntelliVue monitors and the Masimo modules. The specific types of ground truth for these physiological parameters would typically involve:

• Reference standard measurements: Comparison against highly accurate and precise clinical instruments for parameters like ECG, SpO2, blood pressure, CO2.
• Clinical observation and expert interpretation: For conditions like arrhythmia detection (ECG) or state of brain monitoring (EEG/BIS/SedLine), ground truth might involve expert review of physiological waveforms and patient state.
• Pathology/Outcomes data: Not explicitly mentioned or typically applicable for patient monitoring as a primary ground truth.

However, this document does not detail the specific ground truth methodologies used in those prior studies.

8. Sample Size for the Training Set

The document describes a 510(k) submission for a patient monitor and the integration of external modules. This type of device relies on established algorithms for physiological parameter measurement, rather than a machine learning model that requires a distinct "training set" in the common sense of AI/ML software. Therefore, the concept of a "training set sample size" as typically used for AI/ML does not directly apply or is not detailed here. The algorithms used in the Masimo modules and the Philips monitor were developed and validated, but this process doesn't align with a "training set" in the AI/ML context.

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

As explained in point 8, the concept of a "training set" in the AI/ML sense is not applicable or detailed in this document for these types of patient monitoring algorithms. Therefore, information on how ground truth for a training set was established is not present. The algorithms' foundational accuracy would have been established through a combination of engineering, physiological principles, and validation against clinical reference standards, as mentioned above for "Type of Ground Truth."

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