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510(k) Data Aggregation
(161 days)
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.
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.
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 is intended to be used as an objective neuromuscular transmission monitor that measures the muscle response to 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 non-invasive Masimo O3 Regional Oximeter System and accessories are indicated 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 SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
The Edwards FloTrac solution offers continuous assessment of hemodynamic parameters. It is indicated to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is indicated for use in adult critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. The Edwards FloTrac solution is indicated to be used in the operating room, intensive care unit, and emergency room.
The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for home use. The monitors are additionally intended for use in transport situations within hospital environments.
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, 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.
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(194 days)
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 <40 kg in healthcare environments.
The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil. Desflurane. Fentanyl. Isoflurane. Nitrous Oxide. Propofol. Remifentanil. and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for use in transport situations.
They are not intended for home use.
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:
-
- 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.
| Test Name | Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Electrical Safety Testing | Tested to recognized consensus standards: IEC 60601-1, IEC 60601-1-8, IEC 62304 | PASSED | PASSED |
| EMC Testing | Tested to recognized consensus standard: IEC 60601-1-2; Tested against common EM emitters | PASSED | PASSED |
| Wireless Coexistence | Test sensitivity of patient monitors to common interferers | PASSED | PASSED |
| Software Integration Testing | Test of new functionality integration into existing software infrastructure | PASSED | PASSED |
| Software Testing | Test of new software functionality ("Test Report for System Requirements Testing," "Test Report for Safety Risk Assessment," "Test Report for Regression Testing," "Test Report for Security Risk Assessment," "Test Report for Compatibility Testing") | PASSED | PASSED |
| Essential Performance Testing | Tests verifying that essential performance requirements are met (for Patient Monitors) | PASSED | PASSED |
| Human Factors | Test of device usability | PASSED | PASSED |
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.
Ask a specific question about this device
(270 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 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 <40 kg, in healthcare environments.
The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentani, Desflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
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."
Ask a specific question about this device
(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.
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