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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. The Vantage Titan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the whole body 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 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.

The provided text is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a detailed study proving the device meets specific performance criteria through clinical trials or statistical analysis of diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to diagnostic accuracy, human-AI collaboration, or detailed ground truth establishment) are not available in this document.

However, based on the information provided, here's what can be extracted:

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

The document doesn't explicitly list "acceptance criteria" in the traditional sense of diagnostic performance thresholds for an AI/CAD system. Instead, it focuses on demonstrating that the new Vantage Titan 1.5T MRI system maintains the safety and effectiveness of its predicate device, primarily through technical specifications and adherence to standards. The "performance" reported is related to maintaining safety and imaging capabilities without raising new safety or effectiveness concerns.

2. Sample sized used for the test set and the data provenance

The document mentions "archived clinical images, simulation testing and bench (phantom) testing" were used for testing (Section 13). However, it does not provide any specific sample sizes for these tests or information on the provenance (e.g., country of origin, retrospective/prospective nature) of the "archived clinical images."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a diagnostic imaging device like an MRI, the "ground truth" for its output (images) is generally understood to be the accurate representation of anatomical structures and their properties, which is then interpreted by a "trained physician" as stated in the Indications for Use (Section 2 and 10). The document does not describe a study involving expert readers establishing ground truth for a test set in the context of diagnostic accuracy assessment for the device as a whole.

4. Adjudication method for the test set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not done or at least not described in this document. This submission is for an MRI system itself, not an AI/CAD system that assists human readers.

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

This is not applicable as the device is an MRI scanner, a diagnostic imaging modality, not an algorithm for standalone diagnosis. Its output (images) requires interpretation by a trained physician.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic AI systems (e.g., expert consensus, pathology) is not directly applicable in the context presented. For an MRI system, the "ground truth" that it aims to capture is the physical reality of the internal anatomical structures and their NMR properties. The device's performance is gauged by its ability to produce clear, accurate, and consistent images that, when interpreted by a trained physician, yield useful diagnostic information. The testing mentioned (archived clinical images, simulation, bench/phantom testing) would implicitly rely on established methods to verify the accuracy and quality of the generated images against physical or known standards.

8. The sample size for the training set

This information is not provided. The document describes testing of modifications to an existing MRI system, not the training of a new AI model with a specific training set.

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

This information is not provided and is not applicable in the context of this 510(k) submission for an MRI machine where "training set" doesn't refer to an AI model's learning data.

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