(88 days)
Vantage Galan 3T 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
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K162183. This system is based upon the technology and materials of previously marketed Toshiba MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
This document describes a 510(k) submission for the Vantage Galan 3T, MRT-3020, V4.6 Magnetic Resonance Imaging (MRI) System. This submission is for modifications to an already cleared device, including increased gradient strength and additional software functionalities (MultiBand SPEEDER, PSIR, MOLLI, V-TISP).
The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of the device's diagnostic performance against specific acceptance criteria for a new clinical indication. Therefore, some of the requested information regarding clinical study specifics (e.g., sample size for test set, number of experts for ground truth, MRMC study effect size) is not explicitly detailed in the provided text, as this type of submission typically relies on equivalence to a previously cleared device's performance.
Here's a summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for diagnostic performance or report specific performance metrics like sensitivity, specificity, or AUC as it would for a novel diagnostic algorithm. Instead, the "acceptance criteria" are related to safety, functionality, and demonstration of substantial equivalence to the predicate device.
| Item | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|
| Safety Parameters | Same safety parameters as predicate (Static field strength, Operational Modes, SAR, dB/dt, Emergency shutdown) | All safety parameters are "Same" as predicate (K162183) |
| Imaging Performance | No change in imaging performance from previous predicate submission (K162183) | "No change from the previous predicate submission, K162183." |
| New Software Functionality | Functionality of PSIR, MOLLI, V-TISP, MultiBand SPEEDER integrated and operating as intended, consistent with their function in the reference predicate (K172878). | Achieved through software validation and clinical imaging. |
| Intended Use/Indications | No change to previously cleared indication or intended use. | "No changes to the previously cleared indication, K162183." |
| Substantial Equivalence | The device is substantially equivalent to predicate devices. | Concluded based on bench testing, phantom imaging, volunteer clinical imaging, and software validation. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "volunteer clinical imaging" was performed. However, it does not specify the sample size for this clinical imaging, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature) for any test set specifically used to evaluate the new software functionalities. This type of information is often provided in a more detailed testing report, which is typically part of the full 510(k) submission but not fully included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As the submission focuses on modifications to an existing MRI system and demonstrating substantial equivalence, detailed diagnostic performance studies with adjudicated ground truth by experts are not typically the primary focus for this type of 510(k). The document states images are "interpreted by a trained physician," implying general clinical practice, not a specific expert panel for a study.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in this document. The device itself is an MRI scanner with enhanced sequences, not an AI-powered diagnostic aide designed to improve human reader performance directly.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes an MRI system with new pulse sequences and gradient capabilities. It is not an "algorithm only" device in the sense of a standalone diagnostic software that produces an output without human interaction. The system produces images that are then interpreted by a trained physician. Therefore, a standalone (algorithm only) performance assessment, as might be done for an AI diagnostic algorithm, is not applicable in this context and was not performed.
7. The Type of Ground Truth Used
For the "volunteer clinical imaging" and general assessment of the MRI system, the ground truth for image quality and diagnostic information is implicitly tied to clinical interpretation by a trained physician, as stated in the Indications for Use. For evaluating the technical performance and functionality of the new sequences (PSIR, MOLLI, V-TISP, MultiBand SPEEDER), the ground truth would be based on expected physical principles of MR imaging and technical image quality metrics. There is no mention of pathology or outcomes data as specific ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. The new software functionalities (PSIR, MOLLI, V-TISP, MultiBand SPEEDER) are described as "techniques" or "sequence enhancements." They are not presented as machine learning algorithms that require a distinct training set for model development in the typical sense. These are likely based on established MR physics principles and refined through engineering and technical validation.
9. How the Ground Truth for the Training Set was Established
As no distinct "training set" for a machine learning algorithm is discussed, the concept of establishing ground truth for a training set is not applicable in this context. The "ground truth" for the development and validation of these MR sequences would be based on principles of physics, signal processing, and expected image characteristics, verified through phantom and volunteer studies.
§ 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.