(613 days)
The MAGLIFE® is a device for monitoring the vital signs of patients who are undergoing a Magnetic Resonance Imaging examination. This device is designed for this special environment where ordinary patient monitoring equipment cannot be used for the following reasons : - * The magnetic and electric fields present in the vicinity of the MRI can interfere with the proper operation of ordinary monitors. - ★ The presence of ferromagnetic materials in an ordinary monitor may influence the homogeneity of the magnetic field and thereby degrade the quality of the image acquired. - * Some magnetic materials can become dangerous projectiles in the presence of large magnetic fields. The indications for use are identical to the indications for vital signs monitoring of patients not undergoing MRI examinations.
The MAGLIFE® MRI-Compatible Vital Signs Monitor is a complete patient monitoring system designed to be installed inside the Faraday Cage. It monitors ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2 (etCO2), N2O concentration (%N2O), minimum inspired CO2, respiration rate, noninvasive blood pressure, and invasive blood pressure. The system consists of three enclosures ; a power supply which is permanently anchored to the floor, an operator console which includes a display and control keypad, and a connection box which is placed near the magnet opening and accepts the patient connections. Output of information includes real-time display of waveforms, digital display of calculated parameters, and audible and visual alarm indicators. Accessories include nonmagnetic patient connections for all parameters. Safety of the operator and patient is ensured by compliance to IEC 601-1.
The provided text describes a 510(k) premarket notification for the MAGLIFE® MRI-Compatible Vital Signs Monitor. The submission focuses on establishing substantial equivalence to a predicate device and includes information on nonclinical and clinical testing. However, it does not explicitly state acceptance criteria in a quantitative, measurable format or present a table of acceptance criteria versus reported device performance.
Instead, the document generally describes the device's function and the outcomes of its testing. Based on the provided information, I can infer the "acceptance criteria" are related to maintaining accuracy and usability in an MRI environment compared to traditional monitoring and showing no significant interference with MRI images.
Here's an attempt to structure the information based on your request, inferring criteria where necessary due to the lack of explicit statements in the original document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Maintain accuracy of vital signs measurements in MRI environment. | Non-clinical testing showed that all parameters (ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2, N2O concentration, minimum inspired CO2, respiration rate, non-invasive blood pressure, invasive blood pressure) "can be monitored in the MRI environment with no significant loss of accuracy." (Specific metrics for "no significant loss of accuracy" are not provided). |
| Compliance with medical device safety standards. | Certified (by GLEM Laboratory) for: NFC 74-010 (CEI 601-1), NFC 74-380, NFC 74-381, NFC 74-382, NFC 74-388. Obtained French approval and GS Label from DEKRA (Germany). |
| Clinical: | |
| Ability to monitor desired parameters in most patients. | "Clinical studies showed that, with experience and operator training, the MAGLIFE® can monitor all desired parameters in most patients." |
| No detectable image distortions or artifacts. | "Clinical studies showed that... [the device] does not produce any detectable image distortions or artifacts." |
| Acceptable signal integrity (e.g., for ECG). | For ECG, "in the majority of cases there are less than 10 % signal artifacts during the scan." However, the ECG was "not usable" in a few cases due to factors like electrode positioning, coil, MR-sequence, and patient. |
| Acceptable performance of optical SaO2 sensor. | Acknowledged to be "more sensitive to motion artifact than the electrical one especially in the case of babies." (No explicit threshold for "acceptable" is given). The SaO2 parameter was one of the most used. |
2. Sample size used for the test set and the data provenance
- Sample Size: More than 200 patients.
- Patient Demographics: 80% babies, 5% adults under anesthesia. Approximately 25% of the babies were premature with a weight less than 2 kg.
- Data Provenance: The study was conducted over a two-year period. The country of origin is not explicitly stated, but the submitter's address is in France, making it highly probable the clinical study was conducted there. The study appears to be prospective as it describes monitoring patients over a period.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on monitoring performance rather than a diagnostic accuracy study where expert adjudication is typical.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any formal adjudication method. This is expected as the study is about vital signs monitoring performance and interference, not diagnostic classification.
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 was no MRMC comparative effectiveness study done. The device is a vital signs 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 entire product, the MAGLIFE® monitor, is a standalone device in the sense that it performs monitoring and displays data independently. The "clinical studies" section describes the performance of this device in a clinical setting, which inherently includes its standalone capabilities in capturing and processing data, with human operators overseeing and interpreting the displayed information. There is no specific "algorithm-only" study separated from the integrated device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the vital signs measurements would be derived from the inherent accuracy of the measurement techniques employed by the device itself, likely validated against established reference standards for physiological parameters (e.g., known ECG characteristics, SpO2 calibration, CO2 standards). The "non-clinical testing" section mentions validation against "Performance of each module" according to NFC standards (NFC 74-381, NFC 74-382, NFC 74-388), implying calibration and accuracy checks. For the clinical observations about "signal artifacts" or "ECG not usable," the ground truth is likely clinical observation and judgment by the medical staff using the device.
8. The sample size for the training set
This information is not provided. The document describes clinical studies used to demonstrate performance and safety, but it does not mention a distinct "training set" of patients in the context of machine learning or AI model development. The device is a vital signs monitor, not explicitly described as employing AI that would require a separate training dataset.
9. How the ground truth for the training set was established
As no training set is described for an AI component, this information is not applicable.
§ 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.