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Imaging of:

• The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), 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 .

This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K983110). All other technology used for the EXCELART system is the same as that of the cleared VISART™/Hyper system.

The provided text is a 510(k) Premarket Notification for the EXCELART Magnetic Resonance Diagnostic Device Accessory (MRI System). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent clinical study results with detailed acceptance criteria and performance metrics for a new, non-inferiority claim.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudications are not explicitly stated or applicable in the context of this 510(k) submission.

Here's an analysis of the provided information relative to your request:

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

The submission does not outline specific, quantitative acceptance criteria for image quality or diagnostic accuracy in the way a clinical study for a new AI device would. Instead, it demonstrates that the EXCELART system's safety and imaging performance parameters are comparable to its predicate device, the VISART™/Hyper system.

Study to prove device meets acceptance criteria:

The "study" presented is less a formal clinical trial and more a comparison of technical specifications and design similarities to a previously cleared device. The core argument for meeting acceptance criteria (i.e., being safe and effective) is substantial equivalence to the VISART™/Hyper MRI system (K965068). The modifications (short bore magnet and gantry design) are stated to "not raise new questions of safety or efficacy."

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

• Sample Size: Not applicable/not provided. This is a technical comparison for substantial equivalence, not a clinical study on a test set of patient data.
• Data Provenance: Not applicable. The data primarily consists of engineering specifications and design details of the device itself, compared to a predicate device.

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

• Number of experts & Qualifications: Not applicable. Ground truth as typically defined for clinical performance (e.g., diagnostic accuracy studies) is not established in this document. The "ground truth" for this submission is the established safety and efficacy of the predicate device (VISART™/Hyper) and the technical measurements of the EXCELART system itself.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There is no test set in the sense of patient cases requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• MRMC study: No. This document is a 510(k) submission for substantial equivalence based on technical specifications and design, not an MRMC comparative effectiveness study involving human readers or AI assistance.

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

• Standalone performance: Not applicable. The EXCELART is an MRI system, not an AI algorithm.

7. The type of ground truth used

• Type of ground truth: The "ground truth" for this submission is the established safety and effectiveness of the predicate device (VISART™/Hyper), as determined by previous FDA clearance, and the technical specifications and performance measurements of the EXCELART system demonstrating comparability. The software (V4, K983110) is also previously cleared.

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/machine learning device that would have a training set.

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

• Ground truth for training set: Not applicable. (As above, not an AI/ML device).

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