(11 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 1. Basic Incubator Performance | The basic incubator performance of the LMT nomag IC 3.0 is defined by the IEC particular standard. The design changes over the nomag IC 1.5. do not affect these performance figures. |
| (Implicit) 2. Compatibility with MR Scanners (No Adverse Effects on Incubator) | During testing, the incubator has shown no adverse effects in its behavior due to the MR scanner. |
| (Implicit) 3. Compatibility with MR Scanners (No Significant Artifacts in Imaging) | Imaging has not shown significant artifacts caused by the incubator. |
| (Implicit) 4. Compatibility with MR Scanners (No Influence on Other Scanner Functions) | Other functions of the scanner were also not influenced by the incubator. |
| 5. Compatibility with MR Scanners up to 3T Field Strength | The compatibility to MR scanners with 3T field strength has been proven. |
| 6. Compliance with Harmonized Standards | The LMT Nomag IC 3.0 incubator is compliant with international harmonized standards for incubators by the IEC, specifically IEC 60601-2-20: 1996 and IEC 60601-1 (Ed.2): 1995. |
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.
§ 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).