(116 days)
The NIDO Baby Magnetic Resonance Imaging System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal or infant head. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The NIDO Baby Magnetic Resonance Imaging System is applicable to neonatal or infant head with circumference of up to 50 cm and weight up to 15Kg.
The NIDO Baby Magnetic Resonance Imaging System, model LCM-MRI-3500-01A, is a specialized open-type MRI system designed for neonatal and infant head imaging. The system utilized a 0.35 Tesla (T) permanent magnet to acquire 2D single-slice, multi-slice, and 3D volume images of the brain.
Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses strong magnetic fields, radio waves, and a computer to produce detailed images of the internal structures of the body. Unlike X-rays or CT scans, MRI does not use ionizing radiation. Instead, it relies on the magnetic properties of atoms in the body, particularly hydrogen atoms, which are abundant in water and fat. When a patient is placed inside the MRI machine, the powerful magnets that create a strong magnetic field around the patient causes hydrogen atoms in the body to align with the field. Once the hydrogen atoms are aligned, radio waves are sent into the body. These waves temporarily disrupt the alignment of the hydrogen atoms. When the radio waves are turned off, the hydrogen atoms return to their original alignment, emitting signals in the process. These signals are detected by the MRI machine and converted into detailed images of the body's internal structures.
The NIDO Baby Magnetic Resonance Imaging System features a 0.35T permanent magnet with an open U-shaped structure, optimized for MR head imaging of neonatal and infant patients. Key components include the magnet system, gradient system, radio frequency (RF) system, spectrometer system, temperature control system and clinical imaging software. The system's gradient field strength is ≤32 mT/m with a slew rate of ≤107 T/m/s. Integrated transceive RF head coil also functions as a patient table, operating within a resonance frequency range of 14.6 MHz to 14.9 MHz is used to acquired MR images and to provide patient safety and comfort during scanning. The high-performance computer console is installed with clinical imaging software, which includes a variety of pulse sequences, such as Spin Echo, Fast Spin Echo, Fast Low Angle Shot Gradient Echo, Fluid-Attenuated Inversion Recovery and Diffusion-Weighted Imaging for Proton Density, T1 weighted, T2 weighted and Diffusion imaging.
The provided FDA 510(k) summary for the NIDO Baby Magnetic Resonance Imaging System focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an Artificial Intelligence/Machine Learning (AI/ML) enabled device.
The document details the device description, indications for use, and a comparison table with two predicate devices (Embrace Neonatal MRI System and Lucy Point-of-Care Magnetic Resonance Imaging Device). It also lists non-clinical tests performed, including software verification, image performance, and software validation. These tests primarily relate to the safety and basic functional performance of the MRI system itself, not specifically to an AI/ML component's diagnostic accuracy or interpretive capabilities.
Therefore, the requested information regarding AI/ML acceptance criteria and study details (such as sample size for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from this document, as it does not describe an AI/ML component or its validation.
The document implicitly states that the "images provide information that can be useful in determining a diagnosis" when "interpreted by a trained physician" (Page 3, 6). This phrasing indicates that the device is an imaging tool requiring human interpretation, not an AI-powered diagnostic aide.
In summary, this document does not contain the information needed to answer your questions about AI/ML acceptance criteria and study proof because the device described is a standard Magnetic Resonance Imaging System, not an AI/ML-enabled diagnostic device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.