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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
• Fluid Visualization
• 2D / 3D Imaging
• MR Angiography / MR Vascular Imaging
• Blood Oxygenation Level Dependent (BOLD) imaging
• Perfusion / Diffusion Imaging
• Proton Spectroscopy

The Vantage Titan (Model MRT 1504/S3) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses the same magnet as the other Vantage MRJ Systems. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology), and has a 1.4 m short magnet. The design of the gradient coil and the WB coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm.

The Vantage Titan MRI System is comparable to the current EXCELART Vantage Atlas-X MRI System (K063361), cleared November 21, 2006 with the following modifications.

• Gantry bore diameter has been increased from 600mm to 690mm at bore center.
• Maximum power of RF amplifier has been increased from 20KW to 35KW.
• RF amplifier cabinet has been added.
• Gradient power supply has been modified to increase the output current from 300A to 550A.
• Transformer cabinet has been modified to cover the system power requirement.

The provided 510(k) Premarket Notification for the Toshiba Vantage Titan MR system (K080038) does not describe acceptance criteria or a study proving that the device meets those criteria in the context of device performance regarding image quality or clinical efficacy.

Instead, this submission is centered around demonstrating substantial equivalence to a previously cleared predicate device (EXCELART Vantage Atlas-X, K063361), following modifications to hardware and software. The primary focus is on ensuring that the modifications do not alter the system's safety parameters or intended use, and that imaging performance remains equivalent to the predicate.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

Important Note: The document explicitly states "IMAGING PERFORMANCE PARAMETERS: No changes from the previous submission, K063361." This means that detailed performance metrics (like signal-to-noise ratio, resolution, contrast, etc.) are not provided nor are specific acceptance criteria for these listed in this document. The submission relies on the predicate device (K063361) having already met such imaging performance criteria, and the modifications in K080038 are deemed not to negatively impact them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As this is a 510(k) submission focused on substantial equivalence through hardware and software modifications, rather than a de novo device or a system with new clinical indications, a specific clinical "test set" study for image quality or diagnostic accuracy is not discussed. The evaluation likely involved engineering tests and comparisons between the modified system and the predicate, but these details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. No "test set" in the context of expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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 MRMC comparative effectiveness study was done as described in this document. This submission is for a general-purpose MRI system, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for an MRI system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided. Given the nature of the submission (demonstrating equivalence for an MRI system), "ground truth" would likely relate to objective physical measurements of image quality, system performance (e.g., field homogeneity, gradient linearity), and safety parameters, compared against the predicate and established standards (like IEC 60601-2-33). These details are not elaborated upon in this summary document.

8. The sample size for the training set

This information is not provided. MRI system design and engineering do not typically involve "training sets" in the sense of machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm is discussed.

In summary:

This 510(k) document is a declaration of substantial equivalence for a modified MRI system. It focuses on ensuring that changes to hardware and software do not negatively impact the device's safety or imaging performance, which is implicitly assumed to be equivalent to the predicate device (K063361). Therefore, it does not contain the detailed clinical study information typically seen for novel diagnostic devices or AI-driven systems. The "proof" relies on the assertion that the modifications are minor and that safety and performance equivalence to the predicate (which was previously cleared) has been maintained.

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