(117 days)
Vantage Titan 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 Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K160632. 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 is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system, model MRT-1510, with V4.0 software. It details the modifications to a previously cleared device and asserts substantial equivalence to predicate devices.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
Acceptance Criteria and Device Performance
The document does not explicitly state specific acceptance criteria (performance targets/thresholds) for the new software functionalities. Instead, it focuses on demonstrating that the modified device remains safe and effective for its intended use, which is to produce diagnostic MRI images. The testing outlined aims to show that the new functionalities perform as expected and do not compromise the device's safety or the quality of the diagnostic images compared to the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
Since explicit quantitative acceptance criteria are not provided, this table will reflect the types of tests performed and the general conclusions rather than specific numerical targets.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Maintenance of imaging performance parameters (e.g., image quality, resolution, contrast) | "No change from the previous predicate submission, K160632" regarding Imaging Performance Parameters. (This implies performance is maintained at the level of the predicate device). |
| Proper functioning of new software functionalities (FFE3D, mUTE, mUTE 4D-MRA, 2D-RMC, MP2RAGE, FSE2D mEcho, FFE2D mEcho, mASTAR, FASE DWI, PSIR, MOLLI, V-TISP, enhanced SPEEDER, improved surfECG R-wave detection) | Demonstrated through:Bench testingPhantom imagingVolunteer clinical imagingSuccessful completion of software validationConclusion: "It is concluded that the subject device is safe and effective for its intended use" and "does not change the indications for use or the intended use of the device." |
| Continued compliance with safety parameters (SAR, dB/dt, operational modes, emergency shutdown) | "No change from the previous predicate submission, K160632" and "hardware and related safety considerations remain unchanged." Tabulated safety parameters (Static field strength, Operational Modes, Safety parameter display, Operating mode access, Maximum SAR, Maximum dB/dt, Potential emergency condition) are identical to the predicate. |
| Conformity to applicable consensus standards (IEC 60601-1, IEC 60601-2-33, IEC 60601-1-2, IEC 60601-1-8, IEC 60825-1, IEC 62304, IEC 62366) | "This device is in conformance with the applicable parts of the following consensus standards..." |
| Software documentation for moderate level of concern | "Software Documentation for a Moderate Level of Concern... is also included as part of this submission." |
Study Details
The document describes the testing performed to support the substantial equivalence claim, primarily focusing on general types of testing rather than a specific clinical study with detailed methodology as one might expect for a novel diagnostic algorithm.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "volunteer clinical imaging" but does not specify the number of volunteers or cases.
- Data Provenance: The document implies testing was conducted by Toshiba Medical Systems Corporation (TMSC) in Japan and/or Toshiba America Medical Systems (TAMS) in the USA, as these are the manufacturing and applicant/US agent locations. The data would likely be prospective as it involves "volunteer clinical imaging" and phantom/bench testing of the new V4.0 software.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document states "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." However, it does not detail the number or qualifications of physicians involved specifically in establishing ground truth for the testing described in this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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:
- No, an MRMC comparative effectiveness study is not mentioned in this document. The submission is for a modification to an MRI system's software adding new pulse sequences and functionalities, not for an AI diagnostic algorithm that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone performance" isn't directly applicable in the context of an MRI system's pulse sequences. The performances described (bench testing, phantom imaging, volunteer clinical imaging) are for the imaging capabilities of the device itself, which generates images for human interpretation. The algorithms are part of the image generation process, not a separate diagnostic tool. The document focuses on the system's performance rather than a specific AI algorithm's diagnostic accuracy in isolation.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not explicitly stated. Given the nature of MRI system validation, ground truth would typically be established by expert radiologists interpreting the images from "volunteer clinical imaging" and comparing them to expected anatomical structures or known pathological conditions (if applicable to the volunteers). For phantom imaging, the 'ground truth' is the known physical properties and configurations of the phantom.
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The sample size for the training set:
- Not applicable / Not specified. This submission is for an MRI system's software update, introducing new pulse sequences and image processing enhancements. It does not describe a machine learning algorithm that requires a "training set" in the conventional sense for a diagnostic AI. The software development and validation process would involve iterative testing and refinement, but not a distinct "training set" for an AI model as typically understood in AI/ML submissions.
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How the ground truth for the training set was established:
- Not applicable / Not specified. As there is no mention of a "training set" for an AI model, this question does not apply.
§ 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.