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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 and outside of hospital environments.

The Philips IntelliVue MP5 Patient Monitor is a device for monitoring and recording of and to generate alarms for, multiple physiological parameters. The modification is the introduction of software release G.1.

Here's a summary of the acceptance criteria and study information based on the provided text for the Philips IntelliVue MP5 Patient Monitor:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing quantitative acceptance criteria and corresponding reported device performance metrics. Instead, it states:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "Verification, validation, and testing activities."

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

The document does not provide information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with or without AI assistance. The device is a patient monitor, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone (Algorithm Only) Performance Study

The document describes "system level and regression tests as well as testing from the hazard analysis" to establish performance, functionality, and reliability. This implies standalone testing of the software (algorithm only) as part of the system, but specific details or dedicated "standalone study" results are not provided beyond the general statement of meeting requirements.

7. Type of Ground Truth Used

The document implies that the ground truth for testing was based on "specifications cleared for the predicate device" and "reliability requirements and performance claims." This suggests internal engineering specifications and expected performance, rather than external expert consensus, pathology, or outcomes data in a clinical trial sense.

8. Sample Size for the Training Set

The document does not mention any training set or its sample size. This is a software update for a patient monitor, and the testing described focuses on verification and validation against established specifications, not on an AI model that requires a distinct training phase.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

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Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.

The modified Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740. The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.

The provided document is a 510(k) summary for the Philips MP5 IntelliVue Patient Monitor. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the specific details about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications that you requested for a detailed study description.

The document broadly states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, EMC, safety and environmental testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims."

This statement is very general and does not provide the specific quantitative information you are looking for. It confirms that testing was done and performance claims were met, but it lacks the detailed breakdown of the acceptance criteria and results.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document is a regulatory submission summary, not a detailed technical study report.

Here's what I can extract and what is missing:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. The device manufacturer is in Germany, but the testing details are not provided.
• Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. This document pertains to a patient monitor, which would likely be evaluated against reference standards (e.g., highly accurate sensors, calibrated equipment) rather than expert human interpretation for ground truth.

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

• Not applicable/Not specified. (See point 3)

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/Not specified. This is a patient monitor, not an AI-assisted diagnostic tool for human readers.

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

• The testing described, "system level tests, performance tests, EMC, safety and environmental testing," generally refers to standalone device performance against specifications. There's no mention of a human-in-the-loop study.

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

• Not explicitly defined, but for patient monitors, the "ground truth" for physiological parameters (like ECG, blood pressure, temperature) would typically be established by highly accurate and calibrated reference measurement devices.

8. The sample size for the training set

• Not applicable/Not specified. This device is not described as having a "training set" in the context of machine learning or AI. Its core technology would be signal processing and hardware integration, not learned algorithms from a dataset.

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

• Not applicable/Not specified. (See point 8)

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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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