(9 days)
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:
| Acceptance Criteria (Imaging Quality) | Reported Device Performance (LMT nomag IC 1,5) |
|---|---|
| Decrease in Signal to Noise Ratio (SNR) | 0 to 2% for most sequences |
| Image Artefacts (geometric distortion, ghosting, uniformity) | "no significant artefacts caused by the incubator" |
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.
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).