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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 <40 kg, in healthcare environments.

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.

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

The document explicitly states: "The IntelliVue Patient Monitors MX500 and MX550, like the predicate device, did not require clinical trials."

Therefore, there is no "test set" in the traditional sense of a clinical study involving patients or human readers. The evaluation was based on non-clinical bench testing and compliance with harmonized standards.

• Sample Size for Test Set: Not applicable as no clinical test set was used.
• Data Provenance: Not applicable. The data is from in-house bench testing and compliance evaluations against recognized standards.

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

Not applicable. As no clinical trials or human-in-the-loop performance studies were conducted for this submission, there was no need for experts to establish ground truth in the context of a test set involving patient data or diagnostic interpretations. The ground truth for the functionality of the integrated Masimo modules is established by their prior clearance as standalone devices (reference devices K162603, K123043, K171121).

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission states, "The IntelliVue Patient Monitors MX500 and MX550, like the predicate device, did not require clinical trials." This indicates that there was no study involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

While there isn't an "algorithm only" study defined in the context of AI, the performance of the integrated components (Masimo O3, IRMA CO2, ISA CO2 modules) in receiving and forwarding physiological data was evaluated. This can be seen as a form of standalone testing of the integration without human interpretation. The original Masimo devices (reference devices) would have undergone their own standalone validation studies prior to their clearances (K162603, K123043, K171121), which are implicitly relied upon here. This submission focuses on the integration into the Philips monitor.

7. Type of Ground Truth Used

For the integrated measurement modules:

• Previous FDA clearances of reference devices: The performance and safety of the Masimo O3 Regional Oximeter System, Masimo Infrared Mainstream Gas Analyzer CO2, and Masimo Infrared Sidestream Gas Analyzer CO2 were established during their original 510(k) clearances (K162603, K123043, K171121). This forms the "ground truth" for their individual measurement capabilities.
• Compliance with harmonized standards: For the overall monitor and its specific functions (e.g., electrical safety, EMC, alarm systems), the ground truth is defined by meeting the requirements of internationally recognized standards (e.g., IEC 60601 series, ISO 80601-2-55).
• Bench testing results: In-house bench testing validated the system-level specifications, mechanical/electrical aspects, and software functionality according to pre-defined internal test protocols and specifications derived from design requirements.

8. Sample Size for the Training Set

Not applicable. This device is a patient monitor with physiological measurement capabilities, not an AI/machine learning device that requires a training set in the typical sense. Its functionality is based on established engineering principles and validated measurement technologies.

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

Not applicable, as there is no training set for this device.

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