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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 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.

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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 EC11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The subject devices Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The specific models differ in the size of their flat panel displays and in the number of supported external measurement modules.

MX400 has a 9" display, MX450 and MX500 have a 12" display and MX550 has a 15" display. In addition to the MX400 and MX450, the MX500 and MX550 models have three integrated slots for use with the dedicated external plug-in modules.

The monitors do not have any built-in measurements. They are intended to be connected to any one of the external IntelliVue family physiological multi-measurement modules and/or (MX500/MX550 only) to the IntelliVue plug-in measurement modules.

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, C.O., CCO, intravascular SO2, spirometry, EEG, gas measurements, and NMT. The interaction with the patient depends on the monitored physiological parameter(s).

The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. The monitors can also be used mobile, during patient transport in a hospital setting.

The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure.

The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port.

The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The modification, which is subject of this Premarket Notification, enables the IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 via software update to support two additional features: Remote Display application and Remote Applications, The Remote Display application feature provides the possibility to view an independent monitor screen on an external display and to operate patient monitor from the external display.

The Remote Applications feature allows the user of the patient monitor to access remotely hosted, pre-configured applications made available by the hospital.

The added functionalities are the same as those already provided by other legally marketed Philips IntelliVue Patient Monitors, such as predicate model MX800. For access to the Remote Applications, the predicate Intelli Vue Patient Monitor MX800 supports commercial application server technology, whereas the modified IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 support commercial application server technology as well as the HTML5 protocol for compatibility with standard web application servers

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors MX400, MX450, MX500, and MX550, based on the provided 510(k) summary:

This submission describes a software update to existing patient monitors, adding "Remote Display application" and "Remote Applications" features. Therefore, the V&V activities primarily focus on confirming the correct functioning of these new software features and ensuring that previously cleared functionalities are not negatively impacted.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is a software update for existing devices, the "acceptance criteria" are primarily related to the successful implementation and verification of the new features and the continued performance of existing features. The document highlights the meeting of existing specifications and "pass/fail criteria" from previous clearances.

• Correct presentation of parameter data on the Remote Display.
• Correct presentation of alarm and/or INOP information on the Remote Display.
• Correct presentation of operating windows on the Remote Display.
• Ability to operate patient monitors from the Remote Display.
  Remote Applications:
• Correct display of remote applications on the monitor screen.
• Operability of remote applications with user input devices. | Remote Display Application:
  "The conducted tests demonstrate that parameter data, alarm and/ or INOP information and operating windows provided by the modified patient monitors are correctly presented on the Remote Display and that the patient monitors can be operated from the Remote Display."
  Remote Applications:
  "The conducted tests demonstrate that the remote applications are correctly shown on the display of the modified patient monitors and can be operated with user input devices." |
  | Safety & Risk Mitigation | - All specified pass/fail criteria from Hazard Analysis met.
• Effectiveness of implemented design risk mitigation measures. | "All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures." |
  | Regression/Non-Interference | Unchanged and unaffected functions from the previous software (Rev. K.10) continue to work correctly with the new software (Rev. K.20).
• Safe, effective, and correct operation according to all specifications and labeling claims of the predicate devices. | "The regression tests demonstrate that the modified patient monitors work safely, effectively, and correctly in accordance with all specifications and labeling claims."
  "Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." |
  | General Reliability & Performance | Meeting all defined reliability requirements and performance claims. | "The results demonstrate that the Philips Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 meet all defined reliability requirements and performance claims." |

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

The document does not explicitly state the "sample size" in terms of number of patients or cases for clinical data. Instead, the testing is described as functional and regression testing on the physical devices (monitors).

• Sample Size: Not applicable in the context of clinical patient data. The "sample" would be the specific hardware models (MX400, MX450, MX500, MX550) with the updated software (Rev. K.20). The tests were conducted on these devices.
• Data Provenance: Not applicable as it's not a clinical study involving patient data. The testing was an internal validation and verification (V&V) activity.

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

Not applicable. The ground truth for this type of V&V (functional and regression testing of software features on a patient monitor) is the expected behavior and output of the device as defined by its specifications and design documents. It does not involve expert clinical assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable. This was internal engineering and software testing against predefined functional and non-functional requirements and previous device specifications. It does not involve adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a software update to a patient monitor, adding features for remote display and remote application access. It does not involve an AI component for interpretation or diagnosis, nor does it involve human readers assessing cases.

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

Not applicable. The device is a patient monitor, which continuously collects and displays physiological parameters. The new features (Remote Display and Remote Applications) are functionalities that enhance how users interact with and access data from the monitor. There isn't a standalone "algorithm" in the diagnostic or interpretative sense tested separately.

7. The Type of Ground Truth Used

The ground truth used for this V&V was based on:

• Device Specifications: The pre-defined expected outputs and behaviors of the patient monitor and its new features.
• Predicate Device Performance: The established performance and specifications of the previously cleared IntelliVue Patient Monitors (Rev. K.10 and MX800 models).
• Hazard Analysis Requirements: Safety criteria and risk mitigation effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for the software involves its development, coding, and internal debugging processes, not a dataset in a machine learning context.

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

Not applicable, as there is no training set in the machine learning sense.

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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 ECI1).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

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 Patient Monitor MX400 and MX450 is a modification of the legally marketed IntelliVue Patient Monitor MP30.

The MX400 and MX450 are display units with a TFT LCD flat panel display and built-in CPU. The models MX400 and MX450 differ only in the size of their flat panel displays: MX400 has a 9" and MX450 has a 12" display.

The MX400 and MX450 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module and any one of the M3012A, M3014A, M3015A/B or M3016A Measurement Server Extensions, as well as to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO.

The MX400 and MX450 acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The MX400 and MX450 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital.

The MX400 and MX450 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse.

The MX400 and MX450 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN.

This is a description of the acceptance criteria and study for the Philips IntelliVue Patient Monitor MX400 and MX450.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical performance metrics against predefined acceptance criteria for novel functionalities. The acceptance criteria described are broad and relate to safety, effectiveness, and adherence to established standards.

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

The provided summary does not specify a "test set" in the context of patient data or clinical trials. The testing described primarily involves engineering and system-level verification and validation (V&V) activities. Therefore, there is no sample size for a test set of patient data, nor is there information on data provenance (e.g., country of origin, retrospective/prospective). The validation focuses on the device's adherence to technical standards and its functional performance when connected to existing, already cleared measurement modules.

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

This information is not applicable. The validation described is not a clinical study requiring expert interpretation of medical data to establish ground truth. It is a technical V&V process ensuring the device's proper functioning and adherence to standards.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons mentioned in point 3.

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

No MRMC comparative effectiveness study was done. The submission is for a modification of an existing patient monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance

The concept of "standalone performance" (algorithm only without human-in-the-loop) is not directly applicable in the context of this traditional patient monitor device. The device itself is a monitor that displays physiological parameters measured by external modules. Its "performance" is evaluated based on its ability to accurately acquire, display, and manage data from these modules, and adhere to safety and functional standards. The summary details regression testing which essentially verifies the standalone functioning of the device's internal components, software, and interfaces according to its specifications.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation activities described in the 510(k) summary are primarily:

• Recognized consensus standards: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-8, IEC 62304.
• Specifications cleared for the predicate device: The MX400 and MX450's performance was compared against the established specifications and performance of the legally marketed IntelliVue Patient Monitor MP30.
• Internal design specifications: The device's own defined specifications for its functions, such as battery operating time, display functionality, and interface performance.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's V&V.

8. Sample Size for the Training Set

This information is not applicable. The IntelliVue Patient Monitor MX400 and MX450 are hardware devices with software, not a machine learning or AI algorithm that requires a "training set" of data.

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

This information is not applicable for the reasons mentioned in point 8.

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