(44 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alparming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50. are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.
The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release E.01 software for the IntelliVue patient monitor devices.
Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitors, Release E.01, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the device's functions. Instead, it makes a general statement about meeting predetermined specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Specifications cleared for the predicate device were met. | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." |
It's important to note that for a medical device such as a patient monitor, "specifications cleared for the predicate device" would typically encompass a wide range of performance parameters for each physiological measurement (e.g., ECG accuracy, NIBP accuracy, SpO2 accuracy, arrhythmia detection performance). However, these specific numerical criteria are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only 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, and safety testing from hazard analysis."
Without further details, we cannot infer the nature or origin of the test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary does not provide information on the number or qualifications of experts used to establish ground truth for any test set. Given the nature of a patient monitor, ground truth for physiological parameters would likely come from validated reference devices or established clinical methods, rather than expert interpretation of raw data.
4. Adjudication Method for the Test Set
The 510(k) summary does not specify any adjudication method for a test set. This type of method (e.g., 2+1, 3+1 consensus) is typically used for subjective assessment tasks, such as image interpretation, which are not directly applicable to the functional testing of a patient monitor.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not discussed or indicated in the provided 510(k) summary. MRMC studies are primarily relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance, to assess changes in diagnostic performance. This device is a patient monitor, not an AI-assisted diagnostic imaging tool in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The testing described is inherently standalone for the monitoring functionalities. A patient monitor's algorithms continuously process physiological signals without direct human intervention in the data processing itself. The summary implies "system level tests, performance tests, and safety testing," which would evaluate the device's algorithms and hardware independently of a human operator, while acknowledging that a human uses the displayed information.
7. The Type of Ground Truth Used
While not explicitly stated for each parameter, the ground truth for a patient monitor's performance tests would typically involve:
- Reference Devices: Using highly accurate and calibrated reference devices for each physiological parameter (e.g., an invasive blood pressure catheter for NIBP accuracy, a calibrated ECG simulator for arrhythmia detection, a gas analyzer for capnography).
- Clinical Measurements: Comparing monitor readings to gold-standard clinical measurements performed by trained professionals.
- Simulated Data: For certain performance aspects like arrhythmia detection, using validated physiological waveforms that contain known arrhythmias.
8. The Sample Size for the Training Set
The 510(k) summary does not mention a training set or its sample size. This is because the device, the Philips IntelliVue Patient Monitor, is a traditional physiological monitoring device, not an AI/machine learning device that requires a distinct "training set" to develop its algorithms. Its algorithms are based on established physiological principles and signal processing techniques.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for this type of device, the concept of establishing ground truth for a training set is not applicable here. The algorithms for a patient monitor are developed based on scientific and medical principles, and then validated (tested) against known reference standards.
§ 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.