(21 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 hospital environments and during transport within hospital environments.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
The Philips MP40 and MP50 patient monitors. The modification is the merging of existing battery operation functionality for the IntelliVue patient monitor models MP40 and MP50.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Philips IntelliVue MP40 and MP50 Patient Monitors:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) summary) does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on a qualitative statement of substantial equivalence to previously cleared predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (as implied) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Overall Performance | Substantial equivalence to predicate device performance. | "The results demonstrate that the Philips IntelliVue Patient Monitor meets all reliability requirements and performance claims." |
| Reliability | Meets reliability requirements of the predicate device. | "meets all reliability requirements" |
| Functionality | Maintains functionality of predicate device. | Established through "system level tests, performance tests, and safety testing." |
| Safety | Meets safety standards and maintains safety of predicate device. | Established through "safety testing from hazard analysis." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "system level tests, performance tests, and safety testing," but does not quantify the number of units or test cases involved.
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not explicitly detailed. The device submitter is located in Germany, but it doesn't specify if the testing data originated from there or elsewhere.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on engineering tests against established specifications.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on meeting technical specifications rather than subjective interpretation or diagnostic accuracy assessments that would typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a patient monitor, not an AI-assisted diagnostic tool, and the focus is on demonstrating equivalence to existing hardware rather than improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The concept of a "standalone algorithm" is not applicable here. This submission is for a hardware patient monitor with existing functionality, not a new algorithm or AI-driven feature. The testing described focuses on the overall performance of the integrated device.
7. The Type of Ground Truth Used
The ground truth used for testing appears to be based on the specifications and performance of the legally marketed predicate devices. The document states, "Pass/Fail criteria were based on the specifications cleared for the predicate device." This means the "ground truth" was the expected, documented performance of the equivalent earlier models.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Philips IntelliVue MP40 and MP50 are patient monitors, which are hardware devices, not AI/ML models that require training sets in the typical sense. The "modification is the merging of existing battery operation functionality."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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.