Search Results

The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N₂O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO-), nitrous oxide concentration (%N2O), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) and temperature tracking.

The monitor consists of line-powered console (with optional back-up battery) which is placed outside the magnet boren, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.

The provided text describes the 510(k) summary for the MAGLIFE C/MAGLIFE C Plus patient monitor. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

The device is evaluated based on its ability to function without degradation in performance within an MRI environment and to not interfere with the MRI unit. The reported performance suggests it meets these criteria.

Since this is a 510(k) submission for a patient monitor and the studies are non-clinical tests, much of the requested information regarding clinical studies, ground truth, and expert evaluation is not applicable or explicitly stated in this document.

Here's an attempt to answer the remaining questions based on the provided text, indicating "Not Applicable" or "Not Stated" where the information is missing:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable as these were non-clinical engineering and bench tests, not patient data tests. The "sample" would be the device itself.
• Data Provenance: Not applicable. The tests were presumably conducted internally by SCHILLER MEDICAL or a contracted testing facility.

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)

• Number of Experts: Not applicable. Ground truth for these non-clinical tests would have been established by engineering standards and direct physical measurements/observations by testing personnel, not medical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This refers to expert review of clinical cases. For non-clinical tests, compliance is typically determined by meeting predefined technical specifications or standards.

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, an MRMC study was not done. This type of study involves human readers interpreting cases, often with AI assistance, which is not relevant for a patient monitor's non-clinical validation.
• Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: While the "device" itself functions standalone in terms of its monitoring capabilities, the testing described is primarily about its physical and electromagnetic compatibility within an MRI environment, not an AI algorithm's standalone diagnostic performance. No "algorithm only" performance study in the context of AI is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the non-clinical tests described, the "ground truth" was established by engineering standards, physical laws, and direct measurement (e.g., whether the device moved, whether images showed visible differences, ability to function at a certain field strength). This is not equivalent to clinical ground truth derived from pathology or expert consensus.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a patient monitor, and there is no mention of an AI/machine learning component that would require a "training set" in the context of the 510(k) summary provided.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set.

Ask a specific question about this device

The Maglife C is a multi-parameter patient monitor which is indicated for monitoring electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N Q), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO2) in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations.

MAGLIFE C is a multi-parameter patient monitor which has been designed for use in the immediate vicinity of a Magnetic Resonance Imagers for the surveillance of patients undergoing MRI examinations. The parameters that can be monitored are electrocardiogram (ECG), pulse oximetry (SpO2), pulse rate, partial carbon dioxide pressure at the end of expiration (EtCO2), nitrous oxide concentration (%N D), partial pressure of inspired carbon dioxide (min inspired CO2), respiratory rate (RR), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), concentration of gas inspired and expired (isoflurane, halothane, enflurane, desflurane, sevoflurane), and fraction of inspired oxygen (FiO).

The monitor consists of a line-powered console (with optional back-up battery) which is placed outside the magnet bore, and appropriate electrodes, transducers, cables and tubes to allow the patient to be monitored during the examination. The console enclosure is a Faraday cage for the protection of sensitive electronic circuits.

The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the Maglife C patient monitor, primarily focusing on demonstrating substantial equivalence to predicate devices based on non-clinical testing and compliance with various standards.

Therefore, I cannot provide the requested information in the format specified.

However, I can extract the available information regarding testing:

Key Takeaways from the document:

• Non-clinical tests were conducted to demonstrate compliance with a list of standards (ANSI/AAMI EC13-1992, EC12-1991, SP10, SP9, BP22-1994, BP23-1986, ES21-1993, and IEC 601-1).
• The device was evaluated for electrical testing based on the November 1993 Reviewer Guidance for Premarket Notification Submissions (Anesthesiology and Respiratory Devices Branch).
• Tests in an MRI unit were performed to:
  • Determine the maximum field strength the Maglife C can withstand without performance degradation.
  • Verify sufficiently small ferrous material content to prevent movement due to magnetic attraction.
  • Assess the effect of Maglife C on the homogeneity of the magnetic field (with a 1.5 Tesla MR unit, showing it could be placed as close as 60 cm from the magnet without visible image differences).
• Conclusion from non-clinical testing: "The testing of the Maglife C demonstrates that the performance is substantially equivalent to predicate devices cited above."

Since the document focuses on non-clinical testing and substantial equivalence, and does not describe clinical studies or specific quantitative acceptance criteria for device performance with corresponding results, it's impossible to fill out the table and answer most of the questions as requested.

Ask a specific question about this device

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

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.

Ask a specific question about this device