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Vantage Titan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional 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 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 us restricted to the approved drug indications. When interpreted by a trained physician, these images vield information that can be useful in diagnosis.

Device Description

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is added to Vantage Titan 3T.

AI/ML Overview

The provided document is a 510(k) summary and FDA clearance letter for a Magnetic Resonance Diagnostic Device, the Toshiba Vantage Titan 3T (MRT-3010/A5). It primarily focuses on demonstrating substantial equivalence to a predicate device and safety parameters, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI-related metrics like standalone performance, MRMC studies, sample sizes for test/training sets, and expert-established ground truth, is not present in the provided text. The submission is for an MRI system and its software packages, not an AI/CADe device that typically undergoes such performance evaluations.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document does not specify performance-based acceptance criteria in the way one would for a diagnostic accuracy study. Instead, it details safety parameters to show equivalence to a predicate device.

Item	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Static field strength	3T	3T
Operational Modes	1st Operating Mode	1st Operating Mode
Safety parameter display	SAR dB/dt	SAR dB/dt
Operating mode access requirements	Allows screen access to 1st level operating mode	Allows screen access to 1st level operating mode
Maximum SAR	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33(2002))	4W/kg for whole body (1st operating mode specified in IEC 60601-2-33(2002))
Maximum dB/dt	<1st operating mode specified in IEC 60601-2-33 (2002)	<1st operating mode specified in IEC 60601-2-33 (2002)
Potential emergency condition and means provided for shutdown	Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects	Shut down by Emergency Ramp Down Unit for collision hazard for ferromagnetic objects
Imaging Performance Parameters	No change from previous predicate submission (K102489)	No change from previous predicate submission (K102489)

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 it's not a clinical performance study in the context of diagnostic accuracy. The testing mentioned refers to design control activities and conformity with standards, not performance on patient data.

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. The submission does not detail a study involving expert establishment of ground truth for a test set.

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

An MRMC study was not mentioned or performed for this submission. The device is an MRI system, not an AI or CADe product designed to assist human readers.

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

A standalone performance study of an algorithm was not mentioned or performed. The submission is for the MRI system itself.

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

This information is not provided. As an MRI system, its "truth" is typically its ability to generate images reflecting the a priori known physics of MRI and depicting anatomical structures. The document states, "When interpreted by a trained physician, these images yield information that can be useful in diagnosis," implying that the final diagnostic "truth" comes from physician interpretation of the images, not from an algorithm.

8. The sample size for the training set

This information is not applicable and not provided. The device is an MRI machine with software packages, not a machine learning model that requires a training set of patient data in the typical sense.

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

This information is not applicable and not provided.

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