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The LMT nomag IC 3.0 MR-incubator is an infant incubator system for temporary use during MR-imaging in clinical environments provided with a suitable trolley for intra hospital transport.

The LMT nomag IC 3.0 MR-incubator provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4.5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).

The LMT nomag IC 3.0 is suitable for use with MR scanners of field strengths up to 3.0T.

The LMT Nomag IC 3.0 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapy. It provides a microclimate of air temperature and humidity suiting the infants needs. The incubator has a trolley for intra clinical transport providing power.

The incubator runs in air control mode and has closed loop control for both air temperature and humidity. Humidification works hygienically via vaporizing of distilled water.

The acceptance criteria for the LMT nomag IC 3.0 neonatal transport incubator and the study that proves its performance are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The text does not explicitly state a specific sample size for the test set in terms of individual incubators or the number of tests performed. However, it mentions:

• "extensive bench testing"
• "testing under MR influence"
• "compatibility with MR scanners of different manufacturers (Siemens, Philips, GE 1.5T and 3T) have been tested according to an established protocol using phantoms."

The data provenance is prospective bench testing conducted in, or on behalf of, LMT Lammers Medical Technology GmbH in Germany, based on the applicant's address.

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

The text does not provide information regarding the number of experts used or their qualifications for establishing ground truth. The evaluation appears to be based on objective measurements and established protocols for MR compatibility and incubator performance.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. The testing appears to rely on direct measurement and observation of incubator function and MR image quality against established protocols and standards ("extensive bench testing," "established protocol using phantoms").

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The LMT nomag IC 3.0 is a medical device (neonatal transport incubator) and not an AI-powered diagnostic or assistive tool for human readers.

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

A "standalone" performance study in the context of an algorithm or AI was not done, nor is it applicable. This device is a physical medical incubator, not a software algorithm. The "standalone" performance here refers to the device's inherent function, which was evaluated through bench testing.

7. The Type of Ground Truth Used

The ground truth used for evaluating the LMT nomag IC 3.0's performance was based on:

• Compliance with International Standards: Specifically, IEC 60601-2-20: 1996 and IEC 60601-1 (Ed.2): 1995.
• Established Test Protocols: "established protocol using phantoms" for MR compatibility.
• Comparison to a Legally Marketed Predicate Device: The LMT nomag IC 3.0 was evaluated against the legally marketed LMT nomag IC 1.5 device to demonstrate substantial equivalence, particularly for factors not affected by design changes and for image evaluation performed "to the same standards."

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device as it is a physical medical device and not a machine learning or AI algorithm.

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

As the concept of a training set is not applicable, the method of establishing its ground truth is also not relevant for this device.

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LMT nomag IC 1,5 is an infant incubator system for temporary use during MR-imaging in clinical environments and in combination with a suitable trolley for intra hospital transport.

LMT nomag IC 1,5 provides a controlled environment of warmth and humidity for premature babies and sick infants up to a body weight of 4,5 kg (10 lbs) and a maximum body length of 55 cm (21.7 inches).

LMT nomag IC 1,5 is suitable for MR scanner of field strengths up to 1.5T.

The LMT Nomag IC 1,5 is an incubator for preterm and term-born infants who are scheduled for Magnetic Resonance (MR) Imaging and are dependant on warming therapv. It provides a microclimate of air temperature and humidity suiting the infants needs. The incubator has a trolley for intra clinical transport providing power.

The incubator runs in air control mode and has closed loop control for both air temperature and humiditication works hygienically via vaporizing of distilled water.

The acceptance criteria and study proving the device meets them can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a numerical count of patients or phantom images. The document mentions "patient and bench testing" and "tested according to an established protocol using phantoms." It also states compatibility was tested with "MR scanners of different manufacturers (Siemens, GE, Philips all 1.5T)." This implies a small, targeted test set to evaluate MR compatibility.
• Data Provenance: The testing appears to be conducted by the manufacturer, LMT Lammers Medical Technology GmbH, in Germany. The nature of "patient testing" isn't further elaborated, so it's unclear if this was retrospective or prospective. Phantom studies are inherently prospective.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The evaluation of imaging quality ("images were evaluated regarding Signal to Noise Ratio (SNR) and artefacts like geometric distortion, ghosting and uniformity") would typically be performed by trained radiologists or MR physicists, but this is not explicitly stated in the provided text.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

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

No, an MRMC comparative effectiveness study was not performed. The study focused on the impact of the incinerator on image quality, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

This device is a neonatal transport incubator, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The performance evaluated was the physical device's impact on MR imaging.

7. Type of Ground Truth Used:

The ground truth for the imaging quality assessment appears to be based on expert evaluation of image quality metrics (SNR, artefacts) relative to expected baseline MR image quality without the incubator. The document implicitly uses the concept of "acceptable" performance based on expert judgment in the context of the benefits of continuous warming therapy.

8. Sample Size for the Training Set:

Not applicable. This device is hardware, not a machine learning algorithm.

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

Not applicable.

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