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Vantage Elan 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 Elan (Model MRT-2020) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Elan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™Σ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Elan provides the maximum field of view of 55 x 50 cm. The Model MRT-2020/A1 is without secondary cooling system and the Model MRT-2020/A2 is with secondary cooling system. The Vantage Elan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.

This document is a 510(k) premarket notification for the Vantage Elan (Model MRT-2020) Magnetic Resonance Imaging (MRI) System. The focus of the submission is to demonstrate substantial equivalence to a predicate device (EXCELART Vantage Titan MRI System, K120638) despite hardware and software changes.

The document does not describe a study to prove acceptance criteria for a device with machine learning or AI components. Instead, it outlines the regulatory review process for a conventional medical imaging device. The "acceptance criteria" and "device performance" in this context refer to the device's conformance to established safety regulations, technical standards, and its ability to produce diagnostic-quality images.

Therefore, for your request, I will interpret "acceptance criteria" as the performance and safety standards the device must meet, and "device performance" as how the Vantage Elan compared to these standards or to its predicate device. Since it's a traditional medical device submission, many of your requested items (like sample sizes for test sets, data provenance, ground truth establishment for AI models, MRMC studies, or standalone algorithm performance) are not applicable or explicitly mentioned in the context you've provided.

Here is an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary "study" mentioned is comparison to the predicate device and conformance to recognized standards, rather than a clinical trial with specific performance metrics for novel AI features.

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

• Sample Size for Test Set: The document mentions "clinical image validation was conducted using volunteers." However, it does not specify the number of volunteers or images used in this validation.
• Data Provenance: Not explicitly stated, but based on Toshiba Medical Systems Corporation being in Japan, and no mention of multi-center international data collection, the data provenance is likely prospective clinical data collected in Japan from volunteers.

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

• The document states, "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." It does not specify the number or qualifications of experts involved in the "clinical image validation." This is a standard regulatory statement for diagnostic imaging.

4. Adjudication method for the test set

• Not specified. The document does not describe adjudication methods for the clinical image validation.

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. This is not an AI/ML device. The document describes a conventional MRI system. Therefore, an MRMC comparative effectiveness study regarding human readers improving with AI assistance is not applicable and was not conducted.

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

• No. This is not an AI/ML device. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

7. The type of ground truth used

• For the "clinical image validation," the ground truth implicitly would be the diagnostic assessment by trained physicians based on the generated MRI images, likely correlated with other clinical information to confirm the accuracy of anatomical representation and diagnostic utility. There is no mention of pathology or outcomes data as direct ground truth for this device's specific validation.

8. The sample size for the training set

• Not applicable. This device is a conventional MRI system, not an AI/ML device, so there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no training set for an AI/ML model for this device.

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