(17 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.
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 MP60, MP70, and MP90 IntelliVue Patient Monitor. The modification is updated software of the Philips Medical System MP60, MP70 and MP90 IntelliVue patient monitor devices.
The provided text describes the Philips MP60, MP70, and MP90 IntelliVue Patient Monitors and their clearance as substantially equivalent to previously marketed devices. However, the document does not contain a detailed study report with specific acceptance criteria and device performance metrics in the format requested.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." It does not provide specific quantitative acceptance criteria (e.g., accuracy, precision) or numerical reported device performance values. It broadly states that the new device "meets all reliability requirements and performance claims."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in quantitative terms. Based on specifications cleared for the predicate device. | "Meets all reliability requirements and performance claims." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set. It does not mention the country of origin of the data or whether the data was retrospective or prospective.
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)
This information is not provided in the document. As this is a patient monitoring device, the ground truth would likely be established through direct physiological measurements or clinical observation, rather than expert interpretation of images. However, the exact methodology for ground truth establishment for testing is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typically relevant for interpretative diagnostic devices (like imaging AI), not for physiological monitors where the device itself measures and presents data. There is no mention of "human readers" or "AI assistance" in the context of improving human performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The entire study described is essentially a standalone performance assessment of the device. The "updated software" is an integral part of the patient monitor, and its performance is evaluated as a standalone system against the predicate device's specifications. The evaluation is focused on the device's ability to accurately monitor physiological parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. For physiological monitors, ground truth is typically established by using highly accurate reference measurement systems (e.g., a calibrated pressure transducer for blood pressure, a reference ECG machine for arrhythmia detection) or direct observation of physiological events.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is a common characteristic of device clearances that involve software updates for existing devices, where the focus is on verification and validation against established specifications, rather than development of new algorithms requiring extensive training data.
9. How the ground truth for the training set was established
Since no training set is mentioned, there is no information on how ground truth for a training set was established.
Summary of the Study:
The study described is a verification and validation effort to demonstrate that the updated software for the Philips MP60, MP70, and MP90 IntelliVue Patient Monitors maintains the same performance, functionality, and reliability as the legally marketed predicate devices. The methodology involved "system level tests, performance tests, and safety testing from hazard analysis." The "Pass/Fail criteria were based on the specifications cleared for the predicate device." The conclusion was that "test results showed substantial equivalence" and the device "meets all reliability requirements and performance claims." This type of submission falls under the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials with detailed statistical reporting of performance metrics.
§ 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.