(21 days)
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.