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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 and recording 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 additionally intended for use in transport situations within hospital environments.

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

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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 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 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

The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, 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 at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:

This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.

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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 and recording 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 additionally intended for use in transport situations within hospital environments.

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

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

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only.

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 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 Protocol Watch 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 (I 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 IntelliVue Patient Monitors MX500 and MX550 are modification of the legally marketed IntelliVue Patient Monitor MP50.

The MX500 and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The models MX500 and MX550 differ only in the size of their flat panel displays: MX500 has a 12" and MX550 has a 15" display.

The MX500 and MX550 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module, any one of the M3012A. M3015A/B or M3016A Measurement Server Extensions. plug-in measurement modules M1006B Invasive Blood Pressure, M1011A Intravascular SQ2, M1012A C.O. /CCO, M1014A Spirometry, M1020B SpQ2, M1027A EEG, M1029A Temperature, 865383 NMT, 865115 IntelliBridge EC10, to the 865298 (TcG10) Transcutaneous Gas Module and to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO, Intravascular SO2, Spirometry, EEG and NMT.

The MX500 and MX550 acquire multiple physiological patient signals (via connected external measurement modules). display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The MX500 and MX550 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.

The MX500 and MX550 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.

The MX500 and MX550 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or WLAN.

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the acceptance criteria not in terms of specific performance metrics or a numerical table, but rather as meeting established standards and specifications. The reported device performance is stated generally as having met all these criteria.

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

The document does not explicitly state a "test set" in the context of clinical data for performance evaluation in the typical sense (e.g., patient cases). Instead, the testing described is primarily focused on engineering verification and validation (V&V) of the hardware and software against technical standards and the predicate device's specifications.

• Sample Size: Not applicable in the context of clinical patient data. The "sample" here refers to the number of IntelliVue Patient Monitor MX500 and MX550 devices tested during V&V activities. The exact number of devices tested is not specified, but it implies multiple units to ensure robustness across manufacturing.
• Data Provenance: The testing was conducted internally by Philips, a German company (Philips Medizin Systeme Boeblingen GmbH). It is retrospective in the sense that it's testing the developed product against predefined engineering and safety standards, rather than a prospective clinical trial gathering new patient data. The document does not mention any data from specific countries of origin related to patient cases.

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

This information is not provided in the document. The "ground truth" in this context refers to engineering specifications and performance expectations, which would typically be established by product design and quality engineers, and regulatory specialists within Philips. There is no mention of external medical experts establishing ground truth for performance in a clinical validation study.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the V&V activities are primarily engineering and safety compliance tests, the "adjudication method" would likely involve internal review and sign-off processes by engineering and quality assurance teams, rather than a clinical adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not conducted or described in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (IntelliVue Patient Monitor MP50) through engineering and safety testing, not on improving human reader performance with AI assistance. The devices are patient monitors, not AI diagnostic tools.

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

The devices are patient monitors which are inherently "human-in-the-loop" as they provide data for healthcare professionals. There isn't a standalone "algorithm-only" performance described, as the core function is to display physiological parameters for human interpretation and action.

7. The Type of Ground Truth Used:

The ground truth used for these V&V activities is primarily engineering specifications, recognized consensus standards, and the performance characteristics of the predicate device (IntelliVue Patient Monitor MP50). These standards and specifications define what is considered "correct" or "safe" performance for the device. There is no mention of pathology, expert consensus on patient cases, or outcomes data as a ground truth for this submission, as it's a device safety and performance submission, not a clinical diagnostic algorithm submission.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. The IntelliVue Patient Monitors MX500 and MX550 are not AI/ML-based algorithms that require a "training set" in the computational sense. They are hardware devices with embedded software designed to acquire, process, and display physiological signals based on established medical science and engineering principles.

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

This information is not applicable as there is no "training set" for these patient monitors.

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