(55 days)
Indicated for use by health care professionals whenever there is a need for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in a hospital environment and during transport situations within and outside of hospital environment.
The modified Philips MP5 IntelliVue Patient Monitor is substantially equivalent to previously cleared Philips MP5 IntelliVue Patient Monitor marketed pursuant to K062392, the M3/M3046A Compact Portable Patient Monitor marketed pursuant to K971910, K992273, K030973, and the Welch Allyn SureTemp® Plus thermometer module marketed pursuant to K031740. The modification adds the capability to the MP5 patient monitor to interface to the legally marketed Welch Allyn SureTemp® Plus thermometer module. The modification also adds the capability to the MP5 patient monitor to function in a transport environment outside of hospitals, such as a road ambulance, airplane or helicopter.
The provided document is a 510(k) summary for the Philips MP5 IntelliVue Patient Monitor. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the specific details about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications that you requested for a detailed study description.
The document broadly 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, EMC, safety and environmental testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims."
This statement is very general and does not provide the specific quantitative information you are looking for. It confirms that testing was done and performance claims were met, but it lacks the detailed breakdown of the acceptance criteria and results.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document is a regulatory submission summary, not a detailed technical study report.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Performance | "Pass/Fail criteria were based on the specifications cleared for the predicate devices" | "Test results showed substantial equivalence. The results demonstrate that the modified Philips MP5 IntelliVue Patient Monitor meets all reliability requirements and performance claims." |
| Specific Parameters | (Not provided in this summary) | (Not provided in this summary) |
| Reliability | (Implied by "reliability requirements") | "meets all reliability requirements" |
| Functionality | (Implied by "functionality characteristics") | (Not specified quantitatively) |
| EMC | (Implied requirements) | Tested, assumed to pass given overall conclusion |
| Safety | (Implied requirements) | Tested, assumed to pass given overall conclusion |
| Environmental | (Implied requirements) | Tested, assumed to pass given overall conclusion |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. The device manufacturer is in Germany, but the testing details are not provided.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This document pertains to a patient monitor, which would likely be evaluated against reference standards (e.g., highly accurate sensors, calibrated equipment) rather than expert human interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. (See point 3)
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
- Not applicable/Not specified. This is a patient monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The testing described, "system level tests, performance tests, EMC, safety and environmental testing," generally refers to standalone device performance against specifications. There's no mention of a human-in-the-loop study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly defined, but for patient monitors, the "ground truth" for physiological parameters (like ECG, blood pressure, temperature) would typically be established by highly accurate and calibrated reference measurement devices.
8. The sample size for the training set
- Not applicable/Not specified. This device is not described as having a "training set" in the context of machine learning or AI. Its core technology would be signal processing and hardware integration, not learned algorithms from a dataset.
9. How the ground truth for the training set was established
- Not applicable/Not specified. (See 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.