(22 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 alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The 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) is restricted to neonatal patients only.
The Philips MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release D.00 software for the IntelliVue patient monitor devices, MP40, MP50, MP60, MP70, MP80, and MP90.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips IntelliVue Patient Monitors, Release D.00:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of numerical acceptance criteria or detailed performance metrics. Instead, it offers a general statement about meeting "specifications cleared for the predicate device." Therefore, the table below reflects this general statement.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Performance, Functionality, and Reliability | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." | This statement indicates that all the specified performance, functionality, and reliability requirements for the predicate device were met. Specific numerical criteria (e.g., accuracy ranges for physiological parameters, alarm response times) are not explicitly detailed in this summary but were likely part of the underlying documentation. |
| Safety Testing | "Safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." | This indicates that the device underwent safety testing based on a hazard analysis, and it met the safety specifications of the predicate device. |
| System Level Tests | "Testing involved system level tests... Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." | The device's overall system functionality was tested and found to be substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the testing. The testing described appears to be internal validation by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts used, nor their qualifications, for establishing ground truth. Given the nature of a patient monitor (measuring physiological parameters rather than diagnostic interpretation of images), the "ground truth" would likely be derived from established reference measurement devices rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is a patient monitor, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context. There is no mention of AI assistance in the context of human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone patient monitor, designed to measure and display physiological parameters directly. The testing described (system level tests, performance tests, safety testing) directly relates to the standalone performance of the monitor. The document describes a standalone performance evaluation of the device's functionality.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, for a patient monitor measuring physiological parameters, the ground truth would most typically be established through:
- Reference Measurement Devices: Using highly accurate and calibrated reference instruments (e.g., dedicated ECG machines for cardiac signals, precise pressure transducers for blood pressure, gas analyzers for gas measurements) to establish the true physiological values against which the monitor's readings are compared.
- Physical Simulators/Phantoms: Using controlled simulators that generate known physiological signals or conditions to test the monitor's accuracy and response.
It is highly unlikely that "expert consensus," "pathology," or "outcomes data" would be the primary ground truth for validating the fundamental performance of a patient monitor in the way it is for diagnostic imaging or clinical decision support AI.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set." The device is a patient monitor with software (Release D.00) that likely incorporates established signal processing algorithms and control logic, rather than a machine learning model that requires a distinct training set in the modern sense. The text refers to "specifications cleared for the predicate device" as the basis for evaluation, implying a comparison to known benchmarks rather than an iterative learning process from a large data set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for a machine learning context, this question is not applicable based on the provided document. The "ground truth" for the device's development and validation would be the physical and physiological accuracy standards it must meet, as defined by its intended use and regulatory requirements.
§ 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.