(25 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 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:
| Criterion Type | Details |
|---|---|
| Acceptance Criteria | "Pass/Fail criteria were based on the specifications cleared for the predicate device." |
| Device Performance | "Test results showed substantial equivalence. The results demonstrate that the Philips IntelliVue MP5 Patient Monitor meets all reliability requirements and performance claims." |
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.
§ 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.