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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.

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