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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 and outside of 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 Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. 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 transcutaneous gas measurement (tcGas) 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 Philips IntelliVue Patient Monitors family comprises the multiparameter patient monitor series: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, and MX800. Each monitor consists of a display unit including built-in or separate central processing unit (CPU) and physiological measurement modules. All monitors share the same architecture of CPU units and exactly the same software is executed on each monitor. The monitors measure physiological parameters such as: Sp02, pulse, ECG, arrhythmia, ST, QT, respiration, invasive and noninvasive blood pressure, temperature, CO2, spirometry, C.O., CCO, tcp02/ tcpCO2, S02, Sv02, Scv02, EEG, and BIS. They generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to the central station. IntelliVue series MP2, X2, MP5, MP5T, MP5SC, MP20, and MP30 are robust, portable, lightweight, compact in size and modular in design patient monitors with interfaces to dedicated external measurement devices. Models MP2, X2, MP5, MP5T, and MP5SC also incorporate multiple built-in physiological measurements. IntelliVue series MP40, MP50, MP60, MP70, MX600, MX700, and MX800 are patient monitors with built-in central processing unit, flat panel display and interfaces to dedicated external measurement devices. Models MX600, MX700, and MX800 have widescreen displays. IntelliVue series MP80 and MP90 are patient monitors with flat panel display and central processing unit as separate components. They have interfaces to dedicated external measurement devices.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured as requested:

Acceptance Criteria and Device Performance Study for Philips IntelliVue Patient Monitors (Software Revision J.04)

Overview:
The submission describes a software modification to existing Philips IntelliVue Patient Monitors (MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700, and MX800) to introduce a new SpO2 intelligent alarm delay feature called 'Smart Alarm Delay'. The study aims to demonstrate that this modified device is as safe and effective as the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a quantitative table of acceptance criteria with corresponding performance metrics for the 'Smart Alarm Delay' feature in the format often seen for diagnostic devices (e.g., sensitivity, specificity, accuracy). However, the "Summary of V&V activities" section outlines the general performance goals and outcomes.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify the exact number of individuals (test persons) involved in the clinical evaluation. It refers to "two user groups - one consisting of physicians and one consisting of nurses" and later "the vast majority of test persons." This suggests a qualitative assessment rather than a statistically powered performance study.
• Data Provenance: Not explicitly stated, but clinical evaluation of user understanding implies prospective testing with healthcare professionals. The country of origin for this specific clinical evaluation is not mentioned.

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

• The "clinical evaluation" appears to focus on user comprehension and acceptance, not on establishing a traditional clinical "ground truth" for diagnostic accuracy.
• Number of Experts: Two user groups were formed: "one consisting of physicians and one consisting of nurses." The exact number of individuals within each group is not provided.
• Qualifications of Experts:
  • Physicians
  • Nurses
  • No specific years of experience or subspecialty are mentioned.

4. Adjudication Method for the Test Set

Not applicable. The clinical evaluation described is a qualitative assessment of user understanding and perception, not a diagnostic accuracy study requiring adjudication of results.

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

No. The document describes a software modification to an existing patient monitor to add an intelligent alarm delay feature. The "clinical evaluation" focused on user understanding and acceptance of this feature, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, not in the traditional sense of a standalone diagnostic algorithm performance study. The modification is an alarm delay feature within an existing monitoring system. The document states:

• "The new 'Smart Alarm Delay' feature is isolated from the SpO2 measurement algorithm, i.e. signal acquisition and numeric processing."
• "The devices hardware and all accessories including, but not limited to the SpO2 sensors remain completely unchanged."
• "The modification does not affect device performance in general and device accuracy in particular."
• Performance aspects covered by ISO 9919 from prior V&V are considered still valid.

This indicates that the fundamental SpO2 measurement accuracy itself was not re-evaluated as a standalone algorithm performance, as the algorithm for SpO2 measurement remained unchanged. The focus was on the alarm delay logic and its user-facing implications.

7. Type of Ground Truth Used

For the "clinical evaluation" regarding the 'Smart Alarm Delay' feature, the "ground truth" appears to be user understanding and subjective opinion as gathered directly from physicians and nurses. For the core SpO2 measurement, the ground truth and performance validation are based on prior verification and validation activities conducted according to ISO 9919 for the predicate device, which are deemed still valid.

8. Sample Size for the Training Set

Not applicable. This submission is for a software modification adding an alarm delay feature, not a machine learning or AI algorithm that requires a dedicated training set for model development. The 'Smart Alarm Delay' is described as being "based on the same fundamental principle" as the predicate's 'SatSeconds' alarm management technique, implying a rule-based or empirically derived logic rather than a learned model.

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

Not applicable, as no training set for a machine learning model was described or used.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP5 is also intended for use during patient transport outside of a hospital environment.

The Philips MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 IntelliVue Patient Monitors. The modification is the introduction of the models MP2 and X2 IntelliVue Patient Monitors and the introduction of software release F.00 for the entire IntelliVue Patient Monitors family, models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90.

The Philips IntelliVue Patient Monitors (models MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90, with software release F.00) are intended for monitoring and recording multiple physiological parameters and generating alarms for adults, pediatrics, and neonates in hospital environments. Some models (MP2, X2, MP20, MP30, MP40, MP50) are also for hospital transport, and the MP5 is for transport outside the hospital. They are intended for use by healthcare professionals.

Acceptance Criteria and Device Performance:

The provided 510(k) summary states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices." However, it does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a table. It generally states that "test results showed substantial equivalence" and that the "results demonstrate that the Philips IntelliVue Patient Monitors meet all reliability requirements and performance claims."

Study Details:

1. Sample size for the test set and data provenance:
   The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "system level and regression tests, safety and performance tests, EMC and environmental tests, such as testing from the hazard analysis."

2. Number of experts used to establish the ground truth for the test set and qualifications:
   This information is not provided in the document.

3. Adjudication method for the test set:
   This information is not provided in the document.

4. Multi-reader multi-case (MRMC) comparative effectiveness study:
   No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to predicate devices through technical verification and validation, not comparative effectiveness with human readers.

5. Standalone (algorithm only without human-in-the-loop performance) study:
   The submission describes testing activities for the device itself ("Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices"). This implies standalone performance testing of the device's functions, but details on specific standalone performance metrics or a study explicitly labeled as such are not provided. The device is a patient monitor, implying continuous monitoring of physiological parameters by the device itself before human interpretation.

6. Type of ground truth used:
   The document does not explicitly state the type of ground truth used for performance evaluation, beyond stating that "Pass/Fail criteria were based on the specifications cleared for the predicate devices." For physiological monitoring, ground truth would typically come from calibrated reference measurements or expert clinical assessment for phenomena like arrhythmia detection.

7. Sample size for the training set:
   This information is not provided. The document describes verification and validation activities for the device, but does not mention "training sets," which implies that this device might not incorporate machine learning or AI that requires a distinct training phase in the way a diagnostic imaging AI would.

8. How the ground truth for the training set was established:
   As no training set is explicitly mentioned or implied to be relevant to the device's development as described, this information is not provided.

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Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP5 is also intended for use in transport situations within hospital environments.

The names of the device is the Philips MP5 IntelliVue Patient Monitor

The Philips MP5 IntelliVue Patient Monitor is a patient monitoring device. The provided text outlines the declaration of substantial equivalence for this device to previously cleared devices. It does not contain detailed information about specific acceptance criteria for performance metrics (like accuracy for heart rate, blood pressure, etc.) or a study that specifically proves the device meets those criteria with granular data and methodology.

However, based on the document, we can infer the approach taken:

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

The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This indicates that the acceptance criteria for the MP5 IntelliVue Patient Monitor were inherently tied to, and met, the established performance specifications of its predicate devices (Philips MP30 IntelliVue Patient Monitor and its modules).

Since specific numerical acceptance criteria and reported performance values for parameters like arrhythmia detection sensitivity/specificity, blood pressure accuracy, or oxygen saturation accuracy are not provided in this summary, a detailed table cannot be created from the given text. The general statement of "substantial equivalence" is the reported overall performance.

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

• Sample Size for Test Set: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not detail the number of patients, test cases, or data points used in these tests.
• Data Provenance: Not specified. There is no mention of the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not applicable/Not specified. This device is a physiological monitor, and its "ground truth" for parameters like heart rate, blood pressure, or oxygen saturation would typically be established by validated reference methods or other highly accurate medical equipment, not by human experts adjudicating diagnoses. The testing would compare the device's readings against these reference standards. If "safety testing from hazard analysis" involved expert review, it is not detailed.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable/Not specified. As mentioned above, "ground truth" for physiological parameters is typically established by reference instruments, not through expert adjudication in the same way as, for example, image interpretation.

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:

• MRMC Study: No. This device is a patient monitor, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this type of device and was not performed.
• Effect Size: Not applicable.

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

• Standalone Performance: The testing described ("system level tests, performance tests, and safety testing") would inherently evaluate the standalone performance of the device's algorithms and hardware in measuring and reporting physiological parameters. While human interaction is involved in setting up and monitoring, the core performance metrics (e.g., accuracy of readings, alarm thresholds) are assessed based on the device's output. However, the document does not break down the results into explicit "standalone algorithm performance" versus "human-in-the-loop performance."

7. The type of ground truth used:

• Type of Ground Truth: Inferred to be reference standard measurements. For physiological parameters measured by a patient monitor (e.g., ECG, blood pressure, SpO2, temperature, gas analysis), the "ground truth" would generally be established using highly accurate and calibrated reference devices or methodologies. For example, a "true" heart rate might be determined by a known ECG simulator, or blood pressure by an invasive catheter with a calibrated transducer.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/Not specified. This document describes a traditional medical device (patient monitor) and its declaration of substantial equivalence, not a machine learning or AI-based device that typically undergoes a distinct "training" phase with a specific dataset.

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

• Ground Truth Establishment for Training Set: Not applicable/Not specified. As above, a "training set" and its associated ground truth are primarily concepts in machine learning/AI development, which is not the focus of this 510(k) summary.

In summary, the 510(k) pertains to a traditional patient monitor. The testing performed focused on verifying that the modified device met the established specifications of its predicate devices, thereby demonstrating "substantial equivalence." The details typically requested for AI/ML-based devices (like MRMC studies, expert adjudication, training set specifics) are not applicable or provided for this type of submission.

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