(195 days)
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 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 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 4-Slot Module rack FMX-4 is intended to connect up to four particular plug-in physiological measurement modules to the dedicated host patient monitors.
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 and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, 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. Whilst MX750 has a 19" flat panel display, MX850 has a 22" display.
The hardware of the new 4-Slot Module Rack FMX-4 is very similar to that of its 8 years old predicate 4-Slot Module Rack FMS-4. The new FMX-4 has the same housing, which is made of the same material as FMS-4 but has a slightly different shade of color (same shade of color as the new MX750 and MX850 monitors). The FMX-4 has a new Printed Circuit Assembly with standard hardware components like CPU and memory being replaced by state of the art electronic components.
The software modifications comprise the following changes:
- Support of the new state-of-the-art electronic components.
- Modified elements of the Graphical User Interface.
- Implementation of a feature called Electronic Strip Recording. This feature allows electronic strips that can be reviewed on the monitor and printed out as a report on the printer.
- Modification of the existing feature Remote Applications to support HTML5 and PDF format.
This document is a 510(k) summary for the Philips IntelliVue Patient Monitors MX750 and MX850 and the IntelliVue 4-Slot Module Rack FMX-4. It states that these devices are substantially equivalent to previously cleared predicate devices (Philips IntelliVue Patient Monitor MX800 and Philips IntelliVue 4-Slot Module Rack FMS-4). The submission primarily focuses on hardware and software modifications to existing devices.
The information provided does not detail specific acceptance criteria and device performance in the format of a table with numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device study. Instead, it describes compliance with recognized consensus standards and general V&V activities. This is likely because the device is a patient monitor, and the modifications are primarily hardware updates and minor software changes to support the new hardware and improve existing functionalities, not a new AI/ML algorithm requiring extensive clinical performance validation against a pre-defined ground truth for diagnostic accuracy.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance) are not explicitly addressed in the provided text as they pertain more to novel diagnostic or AI algorithms rather than general patient monitoring device updates.
I can, however, extract information about the types of tests conducted and general statements about meeting requirements.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific numerical acceptance criteria and corresponding device performance metrics (e.g., sensitivity, specificity, AUC) for the various physiological parameters monitored by the device. Instead, it states that "Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence with respect to safety and effectiveness."
The V&V activities focused on compliance with various international standards:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Electrical Safety) | All applicable requirements have been met. |
| IEC 60601-1-2:2014 (Ed. 4) (EMC) | All applicable requirements have been met. |
| IEC 60601-2-23:2011 (Ed.3) (Non-invasive sphygmomanometers) | All applicable requirements have been met. |
| IEC 60601-2-25:2011 (Ed. 2) (Electrocardiographs) | All applicable requirements have been met. |
| IEC 60601-2-27:2011(Ed. 3) (Electrocardiographic monitoring equipment) | All applicable requirements have been met. |
| IEC 80601-2-30:2009 (Ed. 1.1) and A1:2013 (Automated non-invasive sphygmomanometers) | All applicable requirements have been met. |
| IEC 60601-2-34:2011(Ed.3) (Invasive blood pressure monitoring equipment) | All applicable requirements have been met. |
| ISO 80601-2-55:2018 (Ed. 2) (Respiratory gas monitors) | All applicable requirements have been met. |
| ISO 80601-2-56:2017 (Ed. 2) and A1:2018 (Clinical thermometers) | All applicable requirements have been met. |
| ISO 80601-2-61:2017 (Ed. 2) and Corr1:2018 (Pulse oximetry equipment) | All applicable requirements have been met. |
| IEC 60601-1-8:2006 (Ed. 2.1) and A1:2012 (Alarm systems) | All applicable requirements have been met. |
| IEC 62304:2006 (Ed. 1.1) and A1:2015 (Software lifecycle processes) | All applicable requirements have been met. |
| IEC 60601-1-6:2010 (Ed.3.1) and A1:2013 (Usability) | All applicable requirements have been met. |
| Environmental Testing (Mechanical: Shock, vibration, free fall; Climatic: Temp, humidity) | Specified test requirements have been met. |
| Human Factors Engineering Testing (GUI evaluation) | All specified test requirements have been met and no new hazards have been identified. User feedback led to iterative UI improvements. |
| WLAN Coexistence Testing | The specified pass/fail criteria has been met. |
| Software tests (Safety risk, Software specifications, Security risk) | All tests have been passed. |
| Overall Conclusion | The results demonstrate that the Philips IntelliVue Patient Monitors MX750, MX850 and the IntelliVue 4-Slot Module Rack FMX-4 meet all defined reliability requirements and performance claims. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of subject count or data record count for performance evaluation in the context of, for example, diagnostic algorithm accuracy. The studies described are primarily engineering validation and verification tests against established standards. Therefore, information regarding data provenance (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there is no "test set" described for a diagnostic algorithm, this information is not applicable and not provided in the document. The human factors engineering testing involved "focus groups" and "expert reviews," but the number and qualifications of these experts are not specified, nor were they establishing ground truth for a diagnostic outcome.
4. Adjudication method for the test set
Not applicable, as no dedicated "test set" requiring adjudication for ground truth of a diagnostic outcome is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No MRMC comparative effectiveness study is mentioned. The device is a patient monitor, and the submission concerns updates to an existing monitoring platform, not a new AI diagnostic aid that would typically warrant such a study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is less applicable to a patient monitoring device update. The performance evaluation focuses on the device's ability to accurately measure and display physiological parameters and generate alarms in compliance with safety and performance standards, rather than an autonomous diagnostic algorithm. The document states the monitors are "for use by trained healthcare professionals."
7. The type of ground truth used
For the various measurement parameters (ECG, SpO2, etc.), the "ground truth" implicitly aligns with the accuracy and performance specifications outlined in the referenced standards (e.g., AAMI EC11 for ECG, ISO 80601-2-61 for pulse oximetry). These standards define acceptable deviations from known physical or simulated physiological signals. The document does not describe the establishment of ground truth in the context of expert consensus, pathology, or outcomes data, as would be relevant for a diagnostic AI algorithm.
8. The sample size for the training set
This information is not provided. The document primarily describes hardware and software updates to an existing system, rather than the development and training of a new AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable, as the document does not describe the development or training of a new AI/ML algorithm.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.