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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

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:

• 1. 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.

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.

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Intended Use:

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

Indication for Use:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is only for use on one patient at a time. The monitor is not a therapeutic device. Caution: The monitor is 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 Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only.

Warning: 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 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 monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside the hospital environment. It is not intended for home use.

Warning: The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).

Contraindications: There are no known contraindications for the IntelliVue MX100/X3 Patient Monitor/Multi-Measurement Module.

The Multi-Measurement Module X3 and the IntelliVue Patient Monitor MX10
0, 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 devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The X3 and MX100 can interact with the Central Station via LAN or wireless link.

The Multi-Measurement Module X3 and IntelliVue Patient Monitor MX100 are compact, rugged, lightweight monitors with built-in invasive and non-invasive measurements, namely ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2. It can further extend the measurement capabilities when connecting to the legally marketed IntelliVue Multi-Measurement Extensions

The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.

The provided document, an FDA 510(k) summary for the Philips IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3, describes a device that has undergone technical modifications, primarily software updates, rather than being a novel AI-powered diagnostic or assistive tool.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered diagnostic device, a study proving it meets those criteria, sample sizes for test and training sets, expert usage for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device, as per FDA 510(k) requirements. This typically involves showing that the device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.

Here's why the requested information is absent and what is discussed:

1. Acceptance Criteria for AI Performance and Reported Performance: Not applicable as this is not an AI diagnostic device. The acceptance criteria mentioned are related to compliance with general medical device safety and performance standards (e.g., electrical safety, EMC, software lifecycle, usability, alarm systems).
2. Sample Sizes and Data Provenance: Not applicable for AI model testing. The document states "No new issues of safety or effectiveness as compared to the predicate are introduced because of using this device," indicating that the focus was on validating the software changes within the existing framework of a patient monitor, not on an AI algorithm's diagnostic performance on a specific dataset. There is no mention of a "test set" in the context of AI performance.
3. Number of Experts and Qualifications: Not applicable. Ground truth establishment for AI models is not relevant to this submission.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool that would improve human reader performance.
6. Standalone Algorithm Performance: Not applicable. There is no standalone AI algorithm being assessed.
7. Type of Ground Truth: Not applicable in the context of AI. The "ground truth" for this device would be the accurate measurement of physiological parameters (e.g., ECG, SpO2, NBP), which is assessed through bench testing and compliance with recognized standards, not "expert consensus" or "pathology" in the AI sense.
8. Sample Size for Training Set: Not applicable. There is no AI model training described.
9. How Ground Truth for Training Set Was Established: Not applicable.

What the document does demonstrate (in lieu of AI performance data):

The document primarily focuses on software changes and the continued compliance with established medical device standards to prove substantial equivalence:

• Software Changes: The key difference from the predicate device is a new software version (P.01) introducing new alarm sounds, configurable alarm management, enhancing Early Warning Score Validation, additional SpO2 fallback configuration, additional Lead Diagram presentation for ECG, and enhancement of the global "alarm off" state.
• Non-Clinical Bench Tests and Harmonized Standards: The device has passed safety tests demonstrating compliance with recognized standards like ANSI AAMI ES60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 60601-1-8 (Alarm Systems), and IEC 62304 (Medical device software lifecycle).
• No Clinical Studies: The submission explicitly states, "The subject devices, like the primary predicate devices, did not require clinical trials." This further indicates that the changes were not considered to introduce new safety or effectiveness concerns requiring human subject data for validation.
• Substantial Equivalence: The conclusion is that the modified devices "do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices."

Ask a specific question about this device

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 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 Intelli Vue 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

The IntelliVue Patient Monitors MX400, MX450, 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, 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 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.

This document is a 510(k) Summary for the Philips IntelliVue Patient Monitor MX400, MX450, MX500, and MX550. It does not describe a study involving an AI/algorithm that requires detailed acceptance criteria, ground truth establishment, or specific human reader studies as typically seen for AI-enabled medical devices. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to software and hardware modifications allowing integration with external measurement devices like the Masimo SedLine Sedation Monitor.

Therefore, many of the requested points, particularly those related to AI/algorithm performance studies (e.g., sample size for test set/training set, expert adjudication, MRMC studies, standalone performance, specific effect sizes), are not applicable to this type of 510(k) submission.

However, I can extract information related to the overall device performance and testing as described in the document.

Here's an analysis of the provided text in relation to your request, with an emphasis on what is and is not present:

Device: IntelliVue Patient Monitor MX400, MX450, MX500, MX550

Study Type: This is a 510(k) premarket notification primarily demonstrating substantial equivalence (predicate pathway) for modifications to an existing patient monitor, specifically related to software updates and integration of an external monitoring module (Masimo SedLine Sedation Monitor). It is not a de novo submission for a new AI/algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria for an AI/algorithm's performance (e.g., accuracy, sensitivity, specificity metrics) nor does it provide a "reported device performance" table in that context.

Instead, the "acceptance criteria" can be inferred from the non-clinical tests performed to demonstrate compliance with recognized standards for medical electrical equipment. The "reported device performance" is that the device "passed all safety tests" and "perform as intended."

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable/not specified for an AI/algorithm test set. The testing described is primarily for system-level safety, performance, and software validation.
• Data Provenance: Not applicable in the context of an AI/algorithm dataset. The document discusses compliance with various electrical, safety, software, and usability standards for the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment by experts is typically for diagnostic AI/imaging algorithms. This submission is for a patient monitor system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for expert review of images or clinical data for AI algorithm validation.

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 device is a patient monitor, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm in the sense of a diagnostic or predictive model being evaluated in standalone mode. It's a medical device system. While it has "software," the performance evaluation is centered on its functionality as a patient monitor and its compliance with relevant standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's performance validation is its ability to correctly acquire, display, and alert on physiological parameters according to established benchmarks and safety standards (e.g., AAMI EC11 for ECG, IEC standards for electrical safety). It's not a diagnostic AI's ground truth based on clinical diagnoses or pathological findings.

8. The sample size for the training set

Not applicable. This is not an AI/ML model generated from a training set in the typical sense of deep learning or machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary of what the document does discuss regarding validation and performance:

The document emphasizes non-clinical bench tests and compliance with harmonized standards (e.g., IEC 62304 for software, ANSI AAMI ES60601-1 for basic safety, IEC 60601-1-8 for alarms, IEC 60601-1-6 for usability). The "performance data" section primarily lists these standards and states that the devices "passed all safety tests."

Key statements from the document regarding performance:

• "The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below." (See table in section 1.8 Performance Data)
• "No new issues of substantial equivalence are introduced because of using this device." (Section "Non-clinical Bench Tests")
• "The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo SedLine parameter are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor." (Section "Clinical Studies")
• "Compliance to the FDA Quality System Regulations, FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the subject devices." (Section "Clinical Studies")
• "The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, human factors, usability and interoperability testing, demonstrate that the modified devices do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices." (Section 1.9 CONCLUSIONS)

In conclusion, this 510(k) submission for the Philips IntelliVue Patient Monitor MX series primarily relies on demonstrating compliance with recognized electrical safety, performance, and software development standards, along with a comparison to predicate devices, rather than an AI/algorithm performance study with specific metrics, expert adjudication, or MRMC studies.

Ask a specific question about this device

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

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

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:

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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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 MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

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 Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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 (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 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 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 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 MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 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, heart rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, 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 in the patient vicinity at the bedside. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support further local input devices such as specialized remote control, keyboard, and 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.

With the current software Rev. N.0 the following modifications have been introduced:

• Implementation of the existing feature Alarm Advisor into the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Alarm Advisor provides feedback on recurring and continuous alarm limit violations based on configured criteria. The information provided by the Alarm Advisor supports device operator in adapting alarm limits more specifically. This is the same functionality as that in other IntelliVue Patient Monitors: MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, and MX800 (cleared with K161531).
• Modification of a few specific elements of the Graphical User Interface (GUI) of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, and the Intelli Vue Multi-Measurement Module X3:
  • The key 'Silence' has been renamed to 'Acknowledge',
  • A new default configuration for the Pause/Switch off of alarms via 'Acknowledge' key combined with a specific pop-up window has been added to all monitor models,
  • New default configurations of visual alarm indicators with other colors and flashing behavior of the alarm numerics and limits have been added.

The provided document is a 510(k) premarket notification from Philips Medizin Systeme Boeblingen GmbH to the FDA for their IntelliVue Patient Monitors. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing minor software modifications, specifically the implementation of an "Alarm Advisor" feature and GUI changes related to alarm management.

The document does not contain the specific details required to answer all parts of your request, particularly regarding clinical performance studies with specific acceptance criteria, sample sizes for test and training sets, expert consensus, or MRMC studies for an AI device. This is because the submission is for a patient monitor and its software updates, not an AI-powered diagnostic device in the sense that would require such extensive clinical validation to demonstrate improved human reader performance or standalone algorithm performance.

However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, based on the scope of this type of submission.

Here's an analysis based on the provided text, while acknowledging the limitations for a full AI device performance study:

Acceptance Criteria and Device Performance (as evident from this 510(k) submission):

For this type of device (patient monitors with software updates), the "acceptance criteria" and "device performance" are primarily demonstrated through compliance with recognized standards, hazard analysis, and functional/regression testing rather than a clinical trial with a defined performance metric like sensitivity/specificity for a diagnostic AI.

Study Details (based on the provided document):

Given that this is a 510(k) for patient monitors with minor software updates, the "study" is primarily a series of verification and validation (V&V) activities focused on engineering and software aspects, rather than a clinical trial for an AI diagnostic.

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

   • The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to V&V activities that include:
     • Hazard Analysis Testing: "All specified pass/fail criteria have been met." (No specific sample size of incidents/scenarios mentioned, typically an engineering analysis).
     • Functional System Level Tests: Performed on a variety of monitor models (MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, Multi-Measurement Module X3) for the new features (Alarm Advisor, blinking numerics, Alarm Acknowledge, Pause/Switch off Alarms). No specific number of test cases or "patients" is provided.
     • Regression Tests: Performed on the same range of monitor models to ensure unchanged functions still work.
   • Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The tests are performed on the device itself and its software.

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

   • Not described as "ground truth" establishment in this context. For usability testing, it mentions "expert reviews" as part of formative evaluations, but the specific number and qualifications of these experts are not detailed. These would typically be human factors engineers, clinical specialists, or design experts.

3. Adjudication Method for the Test Set:

   • Not applicable as there is no "test set" of clinical cases requiring adjudication. The V&V activities are based on engineering specifications and standard compliance.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission is for patient monitors and their alarm management and GUI features, which do not involve diagnostic interpretation in that manner. The "Alarm Advisor" provides feedback on alarm limit violations, which is a clinical decision support tool related to device settings, not an image interpretation aid.

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

   • Yes, to an extent, in the sense that the new software features were functionally tested independently of human interaction (e.g., "Functional tests... All tests have been passed"). The "Alarm Advisor" functionality and GUI changes needed to perform as specified by the algorithm/software design. However, this is not a "standalone performance study" in the context of an AI diagnostic that might output a diagnosis or risk score. It's more about verifying software logic and output.

6. The Type of Ground Truth Used:

   • Engineering Specifications and Standards Compliance. For the new features and existing functionalities, the "ground truth" is whether the software performs according to its design specifications, established industry standards (e.g., IEC 60601-1-8 for alarms), and internal quality requirements. For usability, "user feedback" (from focus groups, usability tests) serves as the basis for improvement.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI model that undergoes a "training phase" from a clinical dataset in the traditional machine learning sense. The software development process involves design, coding, and V&V activities.

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

   • Not applicable for the same reason as above.

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The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 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 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 derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and which are mainly free from cardiac arrhythmia.

The PPV measurement is validated for use with adult patients only.

The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature, invasive blood pressure and cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.

The measurement extension can only function when it is connected to a dedicated host device.

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 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 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 devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals.

The measurement sensors are applied at diverse body locations, depending on the actual physiological parameters monitored.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The modification that is subject of this Premarket Notification adds the derived measurement PPV (pulse pressure variation), which is calculated from beat-to-beat arterial pressure values.

The Microstream Extension 867041 adds to the dedicated host device (IntelliVue Patient Monitor or Multi-Measurement Module) physiological measurements: Microstream CO2, and optionally dual invasive pressure and temperature.

The measurement extension is not a stand-alone device; it can only function when it is connected to a dedicated host device.

The modified Microstream Extension now provides the additional optional measurement cardiac output to the host devices.

The provided text contains information about the Philips IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, and IntelliVue Microstream Extension 867041. However, it does not contain specific acceptance criteria values or the results of a study designed to prove the device meets those specific criteria in the format requested, especially for performance metrics like sensitivity, specificity, or reader improvement.

The document focuses on explaining changes made to the devices (addition of PPV measurement and cardiac output measurement), demonstrating substantial equivalence to predicate devices, and listing various verification and validation (V&V) activities performed. These V&V activities generally ensure the device functions as intended and meets safety standards, rather than providing specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy.

Therefore, I cannot populate the table and answer all questions in the requested format based on the provided text.

Here's what can be extracted and what information is missing:

Missing Information (Crucial for the Request):

• Specific Acceptance Criteria Values: The document mentions that "All applicable requirements have been met" and "All specified pass/fail criteria have been met," but it does not specify what those numerical criteria are for the derived measurements (PPV, Cardiac Output accuracy, etc.). For instance, it doesn't say "PPV accuracy must be within X%" or "Cardiac Output repeatability must be less than Y%."
• Reported Device Performance: Due to the absence of specific acceptance criteria, corresponding reported device performance values are also not explicitly stated in a quantifiable manner for diagnostic type performance. It states "The modified devices perform according to the specified criteria," but the numerical results are not provided.
• Sample Size for Test Set: Not mentioned for any performance-related tests involving patient data.
• Data Provenance (Country, Retrospective/Prospective): Not mentioned.
• Number of Experts for Ground Truth: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Adjudication Method: Not mentioned.
• Multi-Reader Multi-Case (MRMC) Study: No mention of an MRMC study or AI assistance. The devices are patient monitors, not AI diagnostic tools that typically involve human readers interpreting images with or without AI assistance.
• Standalone Performance: The performance testing mentioned ("Verification of PPV calculation by comparison to predicate device", "Verification of accuracy and repeatability for right heart measurement" etc.) relates to the device's accuracy in measuring physiological parameters, which is inherently standalone measurement performance. However, specific quantifiable results are not provided.
• Type of Ground Truth: For the "Performance testing of derived measurement PPV" and "Performance testing of Cardiac Output (C.O.)", the ground truth seems to be established against the predicate device's performance or standard measurement techniques. For example, "Verification of PPV calculation by comparison to predicate device."
• Sample Size for Training Set: Not applicable as this is a patient monitor, not an AI or machine learning model that would typically have a separate "training set" in the diagnostic sense.
• How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text for any performance-related tests.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The ground truth for performance was primarily established by comparison to predicate devices or specified criteria derived from standard measurement techniques, rather than expert consensus on patient data.

4. Adjudication method for the test set:

• Not applicable/Not specified. The testing described largely involves verification against technical specifications and predicate device performance, not independent adjudication of clinical interpretations.

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:

• No. The devices are patient monitors that acquire and display physiological parameters, and calculate derived measurements (PPV, Cardiac Output). They are not described as AI-assisted diagnostic tools requiring MRMC studies for human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, implicitly. The performance verification of PPV calculation and Cardiac Output accuracy (e.g., "Verification of accuracy and repeatability") are tests of the device's standalone measurement capabilities. However, specific numerical results of these tests (e.g., actual accuracy percentages or repeatability values) are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Primarily comparison to predicate device performance and compliance with recognized consensus standards and internal specifications. For example, "Verification of PPV calculation by comparison to predicate device" and "All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices."

8. The sample size for the training set:

• Not applicable. These are patient monitoring devices with specified measurement algorithms, not machine learning models that undergo training on a "training set" in the typical sense.

9. How the ground truth for the training set was established:

• Not applicable, as there is no mention of a "training set" for AI/ML algorithms.

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Indications for Use statement for the MX100 and X3:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is 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 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 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.

Indications for Use statement for the Hemodynamic Extension 867039:

The measurement extension adds physiological measurements to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device.

The new IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, and Hemodynamic Extension 867039 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 devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The measurement sensors are applied at diverse bodily locations, depending on the actual physiological parameters monitored.

The new devices have the same range of functions as the legally marketed predicate devices. They use the same measurement parameters as the predicates.

Whereas the predicate devices optionally provide one invasive pressure, the new devices optionally provide two invasive pressures (dual pressure) that can be measured with one pressure connector.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The Hemodynamic Extension 867039 adds optional measurements: dual invasive pressure, temperature, and cardiac output /continuous cardiac output to the host device. The measurement extension can only function when it is connected to a dedicated host device.

Specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications and measurement alarm specifications, are the same as those in the predicate devices. The new devices reuse unchanged existing accessories of the predicates.

The new IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 are compact, rugged, lightweight monitors with built-in measurements. The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.

The MX100 and X3 have a 6.1' TFT flat panel color display with a multi-finger touchscreen as input device.

The MX100 and X3 can interact with the Central Station via LAN or wireless link.

The new Transpac IV Dual IBP Cable 453564588501 is a reusable cable intended to connect two ICU Transpac pressure transducers with one of the new Philips measuring devices (Patient Monitor MX100, Multi-Measurement Module X3, or Hemodynamic Extension 867039). The cable transmits analog voltage signals from the pressure transducers to the Philips device and provides electrical power from the Philips device to the transducers.

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, and IntelliVue Hemodynamic Extension 867039, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in a concise format. Instead, it refers to fulfilling requirements of various recognized consensus standards and device-specific guidance documents. The general statement is:

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

The document does not explicitly state the sample sizes used for various test sets in terms of patient numbers or data records.

• NIBP testing: "minimum of three devices" were compared for intra-device variability.
• Data Provenance: Not specified. The document describes a series of engineering tests and compliance to standards, rather than clinical trials with patient data.

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

This information is not provided in the document. The studies described are primarily engineering verification and validation against established standards and predicate device specifications, rather than relying on expert ground truth for patient data in the typical sense of a diagnostic AI product.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described is against defined technical specifications and standards, not a diagnostic task requiring adjudication of expert interpretations.

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 explicitly mentioned or performed. This device is a patient monitor, not an AI-assisted diagnostic tool that aids human readers in interpreting medical images or data. The focus is on the device's accuracy and reliability in measuring and displaying physiological parameters.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is inherently a "standalone" system in terms of its algorithmic performance for measuring physiological parameters. The studies described (e.g., NIBP accuracy, SpO2 accuracy, respiration rate accuracy) directly assess the device's algorithms and hardware without requiring human intervention in the measurement process itself, though it is intended for use by healthcare professionals.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance testing appears to be based on:

• Reference Standards: For parameters like NIBP, a "comparison to the intra-arterial reference standard for mean blood pressure" was used.
• Predicate Device Specifications: The "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
• Consensus Standards: Performance was evaluated against recognized consensus standards (e.g., IEC, AAMI, ISO) which define acceptable limits for accuracy and performance.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The document describes a medical device, not a machine learning or AI model that requires a "training set" in the conventional sense. The device's algorithms are likely based on established physiological principles and engineering design, not data-driven machine learning models that are "trained."

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

This information is not applicable and not provided, as there is no mention of a "training set" for a machine learning algorithm.

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