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Vantage Titan 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

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 3T (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K143008. This submission will include the following software functionalities: UTE (Ultra Short TE), MP-RAGE, T2:mEcho, T2*:mEcho, Improvements to MRS, Multi b-value DWI, SpineLine+, SureVOI, 2D Real-time Motion Correction (2D-RMC) and eFSBB.

Here's a breakdown of the acceptance criteria and study information for the Vantage Titan 3T (MRT-3010) MRI system, based on the provided document.

It's important to note that this document is a 510(k) summary for a software update to an existing MRI system. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating that the new software functionalities do not introduce new safety or effectiveness concerns and that the system continues to perform as specified, maintaining substantial equivalence to its predicate device. This is often validated through technical performance parameters rather than clinical diagnostic accuracy per se in these types of submissions.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for a "test set" in the context of clinical images used for evaluation. It mentions "sample clinical images" were used, but no quantity or specific details on patients.

• Data Provenance: Not explicitly stated for specific images, but the testing was done by Toshiba Medical Systems Corporation (TMSC) in Japan. The nature of the submission (software update for an existing device) suggests a mix of internal testing data. It does not state if data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth for any "clinical images" in the test set. Given the nature of a 510(k) for a software update to an MRI, the primary focus is on technical performance and maintaining equivalence, not necessarily a new clinical trial for diagnostic accuracy. Interpretation of "sample clinical images" would typically be done by radiologists, but no specifics are given here.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating the safety and effectiveness of new software functionalities against established standards and the predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not a software device in the AI/CAD context. The device is an MRI system. The performance evaluated here relates to the technical capabilities of the MRI system itself and its software. The testing mentioned ("bench testing, phantom image studies") points to standalone technical performance evaluation of the system components and software, rather than an "algorithm only" in the sense of a diagnostic aid. The device is a diagnostic imaging modality intended to be interpreted by a trained physician (human-in-the-loop).

7. Type of Ground Truth Used

The ground truth or reference standard for this submission is primarily tied to:

• Technical Specifications: Conformance to safety and performance parameters outlined in recognized consensus standards like IEC 60601-2-33 (2010).
• Predicate Device Performance: The cleared performance of the predicate device (Vantage Titan 3T, V2.50 K143008) serves as the benchmark for "substantial equivalence."
• Expected Image Quality: For "phantom image studies" and "sample clinical images," the ground truth would be what is considered normal or acceptable image quality and diagnostic information for an MRI of that class. For specific new functionalities (e.g., UTE, MP-RAGE), the 'truth' is whether the sequences generate the expected image characteristics and capabilities for which they were designed.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. The functionalities described (e.g., pulse sequences, automatic positioning assistance, motion correction, filters) are typically developed and refined through engineering expertise, physics principles, and iterative testing rather than statistical training on a large dataset in the way a deep learning model would be.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is identified, the concept of establishing ground truth for it does not directly apply. The development of these MRI software features would involve:

• Engineering Specifications: Designed to meet specific technical requirements.
• Physics Principles: Based on the underlying physics of MRI.
• Expert Knowledge: Input from MRI physicists, engineers, and potentially experienced radiologists on desired image characteristics and workflow improvements.
• Internal Testing and Iteration: Continuous refinement based on bench testing and phantom images.

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