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.

Device Description

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.

AI/ML Overview

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.

Summary

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Date this summary was prepared : 1.
December 18, 1995

Submitter's Name and Address 2.

O.D.A.M. 19, Avenue de la Gare B.P. 50 67162 Wissembourg Cedex FRANCE

Contact Person : Jean-Pierre MABIRE

Telephone	: 33.88.63.36.00
Telefax	: 33.88.54.36.32

3. Device Name

Trade / Proprietary Name	:	MAGLIFE®
Common Name	:	MRI-Compatible Vital Signs Monitor
Classification Name	:	Patient Monitor

・・

4. Predicate Device

The legally marketed device to which equivalence is being claimed :

ォ OMNI TRAK 3100 MRI In vivo Research Inc 12601 Research Parkway ORLANDO FL 32826 USA
510(k) numbers : K864889 - K935020

5. Device Description

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.

のあるのではないと思いませんではないでする

Accessories include nonmagnetic patient connections for all parameters.

Safety of the operator and patient is ensured by compliance to IEC 601-1.

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6. Intended Use

- 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.

7. Comparison of Technological Characteristics

Both the OMNI TRAK 3100 MRI and the MAGLIFE® are multi-parameter vital signs monitors that can be installed inside the Faraday cag for monitoring patient undergoing MRI examinations. Both designs use well accepted measurement techniques that have been modified to optimize performance in the magnetic and electric fields found in the vicinity of the MRI and to prevent interference with the quality of the images. Both monitor ECG, arterial blood oxygen saturation, pulse rate, expired end tidal CO2 (etCO2), N20 concentration (%N20), minimum inspired CO2, respiration rate, non-invasive blood pressure.

The two systems differ in the following respects :

Only the MAGLIFE® offers Invasive Blood pressure. -
Only the MAGLIFE® offers a pulse oximetry sensor for use on the ear. -
MAGLIFE® is intended to be permanently installed in a fixed location within the Faraday ုး cage, while the OMNI TRAK 3100 MRI is a portable outside outside of the shielding room. .

8. Nonclinical Tests Used in Determination of Substantial Equivalence

MAGLIFE is certified (by GLEM Laboraty) about :

്ഥാന്ത്രി വിശ്വീപരിക്കുന്നത് കോട്ടിക്കുന്നു. അവലംബം കാലക്കുന്ന കാലക്കുന്നു. കാലാക്കുന്നും കാലാക്കുന്നു. കാലക്കുന്നും കാലക്കുന്നു. കാലക്കുന്നു കാലക്കുന്നു. കാലക്കുന്നു കാലക്ക

Security of medical devices : NFC 74-010 (CEI 601-1) NFC 74-380 ।
Performance of each module : NFC 74-381 NFC 74-382 NFC 74-388 ।

MAGLIFE obtained French approval by the French health ministery. MAGLIFE obtained GS Label from DEKRA in Germany (Stuttgart)

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Clinical Tests Used in Determination of Substantial Equivalence ഗ്

More than 200 patients (80 % babies, 5 % adults under anaesthesia) were monitored over a two year period. About 25 % of the babies were premature with a weight less than 2 kg. The parameters used most were the SaO2 and the ECG. The optical SaO2 sensor is more sensitive to motion artifact than the electrical one especially in the case of babies.

For the ECG, in the majority of cases there are less than 10 % signal artifacts during the scan. Because of the lead used, the increased motion artifacts, and the extra deviation of the ST segment due to the BO, the ECG is useful mainly for monitoring rhythm. The signal depends on the electrode positioning, the coil, the MR-sequence, and the patient. In a few cases the ECG was not usable.

10. Conclusions from Nonclinical and Clinical Testing

A Children Comments of Children Children

The non-clinical testing showed that all parameters can be monitored in the MRI environment with no significant loss of accuracy.

The clinical studies showed that, with experience and operator training, the MAGLIFE® can monitor all desired parameters in most patients and does not produce any detectable image distortions or artifacts.

The combination ECG-SaO2-Capnography was useful essentially for premature babies. Invasive and noninvasive blood pressure are important in adults.

11. Other Information Deemed Necessary by FDA

ಿನ ನಿಗ್ರಿ ಸಾಮಿರಿಕೆಯ ಕ್ರಮ ಸಾಹಿತ್ಯ ಸಂಸ್ಕಾರ ವಿರುದು ಮಾಡಿ ಮಾಡಿಸುವ ಒಂದು ಪ್ರಾಮದಲ್ಲಿ ಸ

The 510(k) Summary is used by FDA when a member of the public requests information about your 510(k). FDA will send out a copy of only the summary to anyone who requests information. it should be brief, but should mention all the points listed above.

- The summary includes only information that is also covered in the body of the 510(k).
★ The summary does not contain any puffery or unsubstantiated claims.
な The summary does not contain any raw data, i.e., contains only summary data.
★ The summary does not contain any trade secret or confidential commercial information.
★ The summary does not contain any patient identification information.

Regulation Number and Section

§ 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.