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 EC11). 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. 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 subject devices Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The specific models differ in the size of their flat panel displays and in the number of supported external measurement modules.
MX400 has a 9" display, MX450 and MX500 have a 12" display and MX550 has a 15" display. In addition to the MX400 and MX450, the MX500 and MX550 models have three integrated slots for use with the dedicated external plug-in modules.
The monitors do not have any built-in measurements. They are intended to be connected to any one of the external IntelliVue family physiological multi-measurement modules and/or (MX500/MX550 only) to the IntelliVue plug-in measurement modules.
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, C.O., CCO, intravascular SO2, spirometry, EEG, gas measurements, and NMT. The interaction with the patient depends on the monitored physiological parameter(s).
The monitors 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 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. The monitors can also be used mobile, during patient transport in a hospital setting.
The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure.
The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port.
The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.
The modification, which is subject of this Premarket Notification, enables the IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 via software update to support two additional features: Remote Display application and Remote Applications, The Remote Display application feature provides the possibility to view an independent monitor screen on an external display and to operate patient monitor from the external display.
The Remote Applications feature allows the user of the patient monitor to access remotely hosted, pre-configured applications made available by the hospital.
The added functionalities are the same as those already provided by other legally marketed Philips IntelliVue Patient Monitors, such as predicate model MX800. For access to the Remote Applications, the predicate Intelli Vue Patient Monitor MX800 supports commercial application server technology, whereas the modified IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 support commercial application server technology as well as the HTML5 protocol for compatibility with standard web application servers
Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors MX400, MX450, MX500, and MX550, based on the provided 510(k) summary:
This submission describes a software update to existing patient monitors, adding "Remote Display application" and "Remote Applications" features. Therefore, the V&V activities primarily focus on confirming the correct functioning of these new software features and ensuring that previously cleared functionalities are not negatively impacted.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission is a software update for existing devices, the "acceptance criteria" are primarily related to the successful implementation and verification of the new features and the continued performance of existing features. The document highlights the meeting of existing specifications and "pass/fail criteria" from previous clearances.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| New Features Functionality | Remote Display Application: |
- Correct presentation of parameter data on the Remote Display.
- Correct presentation of alarm and/or INOP information on the Remote Display.
- Correct presentation of operating windows on the Remote Display.
- Ability to operate patient monitors from the Remote Display.
Remote Applications: - Correct display of remote applications on the monitor screen.
- Operability of remote applications with user input devices. | Remote Display Application:
"The conducted tests demonstrate that parameter data, alarm and/ or INOP information and operating windows provided by the modified patient monitors are correctly presented on the Remote Display and that the patient monitors can be operated from the Remote Display."
Remote Applications:
"The conducted tests demonstrate that the remote applications are correctly shown on the display of the modified patient monitors and can be operated with user input devices." |
| Safety & Risk Mitigation | - All specified pass/fail criteria from Hazard Analysis met. - Effectiveness of implemented design risk mitigation measures. | "All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures." |
| Regression/Non-Interference | Unchanged and unaffected functions from the previous software (Rev. K.10) continue to work correctly with the new software (Rev. K.20). - Safe, effective, and correct operation according to all specifications and labeling claims of the predicate devices. | "The regression tests demonstrate that the modified patient monitors work safely, effectively, and correctly in accordance with all specifications and labeling claims."
"Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." |
| General Reliability & Performance | Meeting all defined reliability requirements and performance claims. | "The results demonstrate that the Philips Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 meet all defined reliability requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of number of patients or cases for clinical data. Instead, the testing is described as functional and regression testing on the physical devices (monitors).
- Sample Size: Not applicable in the context of clinical patient data. The "sample" would be the specific hardware models (MX400, MX450, MX500, MX550) with the updated software (Rev. K.20). The tests were conducted on these devices.
- Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing was an internal validation and verification (V&V) activity.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for this type of V&V (functional and regression testing of software features on a patient monitor) is the expected behavior and output of the device as defined by its specifications and design documents. It does not involve expert clinical assessment of patient data.
4. Adjudication Method for the Test Set
Not applicable. This was internal engineering and software testing against predefined functional and non-functional requirements and previous device specifications. It does not involve adjudication of clinical findings.
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
Not applicable. This submission is for a software update to a patient monitor, adding features for remote display and remote application access. It does not involve an AI component for interpretation or diagnosis, nor does it involve human readers assessing cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a patient monitor, which continuously collects and displays physiological parameters. The new features (Remote Display and Remote Applications) are functionalities that enhance how users interact with and access data from the monitor. There isn't a standalone "algorithm" in the diagnostic or interpretative sense tested separately.
7. The Type of Ground Truth Used
The ground truth used for this V&V was based on:
- Device Specifications: The pre-defined expected outputs and behaviors of the patient monitor and its new features.
- Predicate Device Performance: The established performance and specifications of the previously cleared IntelliVue Patient Monitors (Rev. K.10 and MX800 models).
- Hazard Analysis Requirements: Safety criteria and risk mitigation effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for the software involves its development, coding, and internal debugging processes, not a dataset in a machine learning context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the machine learning sense.
§ 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.