(108 days)
Vantage Elan systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
- · Proton density (PD) (also called hydrogen density)
- · Spin-lattice relaxation time (T1)
- · Spin-spin relaxation time (T2)
- Flow dynamics
- · Chemical Shift
Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
The Vantage Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.
This document is a 510(k) premarket notification for the Vantage Elan (Model MRT-2020) Magnetic Resonance Imaging (MRI) System. The focus of the submission is to demonstrate substantial equivalence to a predicate device (EXCELART Vantage Titan MRI System, K120638) despite hardware and software changes.
The document does not describe a study to prove acceptance criteria for a device with machine learning or AI components. Instead, it outlines the regulatory review process for a conventional medical imaging device. The "acceptance criteria" and "device performance" in this context refer to the device's conformance to established safety regulations, technical standards, and its ability to produce diagnostic-quality images.
Therefore, for your request, I will interpret "acceptance criteria" as the performance and safety standards the device must meet, and "device performance" as how the Vantage Elan compared to these standards or to its predicate device. Since it's a traditional medical device submission, many of your requested items (like sample sizes for test sets, data provenance, ground truth establishment for AI models, MRMC studies, or standalone algorithm performance) are not applicable or explicitly mentioned in the context you've provided.
Here is an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Regulatory Standards & Predicate Comparison) | Reported Device Performance (Vantage Elan vs. Predicate) |
|---|---|
| Safety Parameters: | |
| - Whole body Maximum SAR (Specific Absorption Rate) conforming to IEC 60601-2-33 (2010), ≤ 4W/kg (1st operating mode) | - 4W/kg for whole body (1st operating mode specified in IEC 60601-2-33 (2010)) |
| - Maximum dB/dt conforming to IEC 60601-2-33 (2010) (1st operating mode) | - |
§ 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.