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The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

The 3150M Fiber-Optic Temperature option enables the measurement of a patient's surface temperature both safely and accurately during all MRI procedures. This option utilizes a fiber-optic cable for interface between the temperature sensor at the patient application site and the measuring device. With this scheme, light channeled through a fiber-optic cable is the medium of temperature measurement rather than electrical conductor based components. The fiber-optic cable is impervious to the RF energy present during MRI procedures, thus eliminating the possibility of heating.

The Fiber-Optic Temperature option contains four items: 1) Re-usable fiber optic surface temperature sensor. 2) Disposable surface temperature sensor applicator for use on patients ranging from Neonatal (5 kilograms) to Adult. 3) Fiber optic connector on the outside of the 3150M. 4) Signal conditioner inside 3150M patient monitor.

The provided text describes the Invivo Research Inc. Magnitude™ 3150M MRI Monitor, which monitors various parameters, including temperature. The focus of the performance testing summary in the document is on the specifications for the temperature option of the device.

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document includes a table of specifications that serve as acceptance criteria for the temperature monitoring function of the device. The reported device performance is stated as conforming to these specifications.

Note: The "Storage Temperature," "Operating Temperature," "Relative Humidity," "Battery Condition," and "Cleaning test" listed in the document are environmental, operational, or durability specifications rather than direct performance metrics of temperature measurement. However, for "Battery Condition," it specifies "± 0.3°C," implying that battery condition does not negatively impact temperature accuracy beyond this tolerance. For clarity, only direct temperature performance criteria are included in the table above.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "This device was verified to function per the following specifications." However, it does not provide details on the sample size for the test set used to verify these specifications for the temperature option.

It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts or any ground truth establishment method involving experts for validating the temperature performance. The specifications are objective measurements (e.g., accuracy, resolution) that would typically be validated against a calibrated reference standard, not expert consensus.

4. Adjudication Method for the Test Set

Given that the performance criteria are objective technical specifications (accuracy, resolution, time to steady state), an adjudication method like 2+1 or 3+1 is not applicable and therefore not mentioned. The device's measurements would be compared against a known standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is typically performed for AI-assisted diagnostic tools where human interpretation of medical images or data is involved. The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is a patient monitoring device that provides direct measurements. Therefore, an MRMC comparative effectiveness study was not performed or described in the provided text, as it's not relevant to this type of device.

6. Standalone Performance Study (Algorithm Only)

The device is a hardware monitoring system that incorporates a fiber-optic temperature option. The performance specifications refer to the direct output of the device itself. Therefore, the "Summary of Performance Testing" implicitly describes the standalone performance of the device's temperature monitoring capability, as it's an algorithm/hardware-only measurement without a "human-in-the-loop" component for interpretation of the raw temperature data.

7. Type of Ground Truth Used

For the temperature monitoring function, the ground truth would typically be established by comparison to a highly accurate and calibrated reference thermometer or temperature standard. The document doesn't explicitly state "ground truth" but implies that the device's measurements were verified against what are considered established standards for temperature measurement to ensure it meets the listed accuracy and resolution specifications.

8. Sample Size for the Training Set

The document describes performance testing for a finished device, not the development of a machine learning algorithm that requires a training set. Therefore, a "training set" in the context of AI/ML is not applicable and no sample size is provided.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm involved, the establishment of ground truth for a training set is not applicable. The device's performance is verified against established metrology standards.

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