(24 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 and pediatrics in hospital environments and during transport inside hospitals.
The name of this device is the MX40 patient monitor.
The provided text describes a 510(k) premarket notification for the Philips MX40 patient monitor. However, the information regarding specific acceptance criteria, detailed study design, sample sizes, expert qualifications, adjudication methods, or specific performance metrics is very limited.
Here's an analysis of what can be extracted and what is missing, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specifications cleared for the predicate device (TRx4841A, IntelliVue Telemetry System Transceiver) | "Test results showed substantial equivalence." |
| "The results demonstrate that MX40 patient monitor meets all defined reliability requirements and performance claims." | |
| Note: The specific "specifications" and "reliability requirements and performance claims" are not detailed in the provided text. The text only states that the new device has "the same technological characteristics as the legally marketed predicate devices." This implies that the performance targets were to match the predicate, but specific numerical targets or results are not given. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions "system level tests, performance tests, and safety testing," but does not indicate whether these involved clinical data, simulated data, or a combination, nor does it mention the country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Ground Truth Establishment: Not mentioned. Given the nature of a patient monitor, "ground truth" would likely involve comparison to established reference standards or expert clinical assessment, but this is not detailed.
4. Adjudication method for the test set
- Adjudication Method: Not mentioned.
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
- MRMC Study: No, this is not an MRMC comparative effectiveness study. The device is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a patient monitor, and its performance would inherently be "standalone" in terms of its physiological measurement and alarm functions. However, the text does not explicitly refer to 'algorithm-only' or 'human-in-the-loop' performance. The evaluations were focused on the device's ability to "monitor and record" and "generate alarms," which are intrinsic functions of the device itself.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. For a patient monitor, ground truth would typically refer to the true physiological state or precise measurements obtained from a gold standard reference device, or expert clinical assessment. The document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics," suggesting an engineering and performance testing approach rather than an explicit "ground truth" in the clinical evaluation sense, although clinical validity would be part of overall performance.
8. The sample size for the training set
- Sample Size for Training Set: This device is a physiological monitor, not a machine learning or AI-driven system that would typically have a "training set" in the common understanding of those terms. Therefore, this information is not applicable or provided.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable (as explained in point 8).
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document broadly states that "Verification, validation, and testing activities" were conducted. These activities involved:
- System level tests: Evaluation of the integrated system.
- Performance tests: Assessment of the device's functional capabilities (e.g., accuracy of physiological parameter measurement, alarm generation).
- Safety testing from hazard analysis: Ensuring the device meets safety requirements.
The acceptance criteria for these tests were based on the existing "specifications cleared for the predicate device" (TRx4841A, IntelliVue Telemetry System Transceiver). The study concluded that the new device, MX40 patient monitor, exhibited "substantial equivalence" to the predicate device and "meets all defined reliability requirements and performance claims."
In essence, the provided text describes a regulatory submission where the new device's equivalence to a cleared predicate device was established through a series of internal verification and validation tests, rather than a detailed clinical trial with extensive ground truth establishment and expert review. The focus was on demonstrating that the new device performs as reliably and effectively as its legally marketed predecessors according to their established specifications.
§ 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.