(11 days)
Indicated for use by health care professionals whenever there is a need for monitoring and recording of, and to whenever enore 15 c, multiple physiological parameters of adults, gencrates and neonates in a hospital environment and during patient transport inside and outside of hospitals.
The Philips MP2 and X2 IntelliVue Patient Monitors are devices for monitoring and recording of, and to generate alarms for, multiple physiological parameters. The modification adds the capability to function in transport environments outside of hospitals.
The provided text describes the Philips MP2 and X2 IntelliVue Patient Monitors, specifically focusing on a modification that extends their use to transport environments outside of hospitals. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K062392, K063725, K071426) for the new intended use.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. A table of acceptance criteria and the reported device performance
The document states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates. Testing involved environmental, EMC, safety and performance tests. 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 MP2 and X2 IntelliVue Patient Monitors meet all reliability requirements and performance claims."
This statement indicates that acceptance criteria existed and were met, but the specific criteria and corresponding performance metrics are not provided in a table within this summary. It refers to "specifications cleared for the predicate devices" as the basis for pass/fail criteria, but these specifications are not detailed.
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, nor does it provide details on the data provenance (country of origin, retrospective or prospective). It broadly mentions "testing involved environmental, EMC, safety and performance tests."
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. The type of testing described (environmental, EMC, safety, performance) suggests engineering and validation testing, not clinical studies requiring expert ground truth establishment for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As mentioned above, the testing appears to be technical performance validation rather than clinical adjudication.
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
There is no indication of an MRMC comparative effectiveness study being performed. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers. The document focuses on the device's ability to maintain its functionality and reliability in new environments.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "performance, functionality, and reliability characteristics of the modified devices." This implies that the device's standalone performance was evaluated against the predicate device's specifications. However, specific details of such a standalone study (e.g., specific metrics, quantitative results) are not provided. The monitors themselves are designed to operate standalone in terms of data acquisition and alarm generation, though they are used by healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the environmental, EMC, safety, and performance tests, the "ground truth" would likely be the established engineering specifications and regulatory standards relevant to patient monitors. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate devices." It does not involve medical ground truth types like pathology or outcomes data.
8. The sample size for the training set
This information is not applicable/provided. The device is an updated version of existing patient monitors, not an AI algorithm that requires a "training set" in the machine learning sense. The testing focuses on hardware and software performance in new environments.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified patient monitor to its predicates for an expanded intended use (transport environments). While it asserts that testing was done and acceptance criteria based on predicate specifications were met, it does not provide the specific details of these criteria, performance results, test methodologies, sample sizes, or any clinical study information (like expert ground truth or MRMC studies) as would be expected for a diagnostic or AI-driven device. The evaluation appears to be based on engineering, safety, EMC, and environmental performance testing.
§ 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.