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Vantage Fortian/Orian 1.5T 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

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Fortian (Model MRT-1550/WK, WM, WO, WQ)/Vantage Orian (Model MRT-1550/U3, U4, U7, U8) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

The Vantage Fortian (Model MRT-1550/WS, WU)/Vantage Orian (Model MRT-1550/AV, AZ) with modified ASGC is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. These Vantage Fortian/Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo Σ and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Fortian/Orian models provide the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

The Vantage Orian (Model MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models use 1.4 m short and 4.1 tons light weight magnet. They include the Canon Pianissimo and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The MRT-1550/ UC, UD, UG, UH, UK, UL, UO, UP models include the XGO gradient system.

The Vantage Orian (Model MRT-1550/AK, AL, AO, AP, A3, A4, A7, A8, AC, AD, AG, AH (Upgrade only)) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian models MRT-1550/A3, A4, A7, A8 use 1.4 m short and 4.1 tons light weight magnet while the Vantage Orian models MRT-1550/AK, AL, AO, AP, AC, AD, AG, AH use 1.4 m short and 3.8 tons light weight magnet. All of the aforementioned models include the Canon Pianissimo and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole-body coil of these Vantage Orian models provide the maximum field of view of 55 x 55 x 50 cm. The Model MRT-1550/AK, AL, AO, AP includes the XGO gradient system. The MRT-1550/A3, A4, A7, A8, AC, AD, AG, AH models include the standard (STD) gradient system.

The Vantage Orian (Model MRT-1550/AS, AT, AW, AX (Upgrade only)) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.0 tons light weight magnet. It includes the Canon Pianissimo and Pianissimo Zen technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Orian provides the maximum field of view of 55 x 55 x 50 cm and include the standard (STD) gradient system.

This system is based upon the technology and materials of previously marketed Canon Medical Systems MRI systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

Based on the provided FDA 510(k) clearance letter and summary for the "Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR" (K253625), here's a description of the acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The submission K253625 is for a modification of a previously cleared device (K250901). Therefore, the acceptance criteria are primarily focused on demonstrating that the modified device remains as safe and effective as the predicate device. The performance parameters listed relate to safety and overall function rather than specific diagnostic accuracy metrics, as no image quality testing was conducted for this specific submission.

Important Note: The document explicitly states "No image quality testing was conducted" for this specific K253625 submission. This implies that the acceptance criteria and performance evaluation for image quality were established and met in the predicate device (K250901), and the current modifications do not impact those aspects, thus not requiring re-testing.

II. Study Details Pertaining to K253625 (Modification of a Cleared Device)

Since this submission is a modification of a cleared device, the "study" primarily consists of verification and validation testing related to the changes, rather than a full clinical efficacy study.

1. Sample Size used for the test set and the data provenance:

   • The document does not specify sample sizes for any test sets. The testing mentioned is "bench testing," "risk analysis and verification/validation testing," and "Software Documentation" testing. These typically do not involve patient data or conventional "test sets" in the clinical study sense.
   • Data Provenance: Not applicable as no explicit clinical test set data from patients is described. The testing refers to internal verification and validation activities.

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

   • Not applicable. The document does not describe a clinical test set requiring expert ground truth establishment for diagnostic performance.

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

   • Not applicable. No clinical test set with adjudicated ground truth is described.

4. 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. The document does not mention any MRMC comparative effectiveness study. The AiCE Reconstruction Processing Unit was already part of the predicate device (K250901) and previous versions (K240238, K191662). This submission focuses on system and software modifications, not a new evaluation of AI assistance.

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

   • Not explicitly stated for this particular submission. The device, being an MRI system with an AiCE (presumably AI-enhanced) reconstruction unit, inherently involves an algorithm. However, the performance assessment described in K253625 is about validating the modifications to the system itself, ensuring it meets safety and functional parameters, and that the software changes are correctly implemented. It does not provide data on the standalone performance of the AiCE algorithm in this context. Such data would have been part of the predicate device's clearance.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not applicable for this submission. The testing is described as "bench testing" and "verification/validation testing," which implies validation against design specifications, functional requirements, and safety standards, rather than diagnostic ground truth from patient studies.

7. The sample size for the training set:

   • Not applicable for this submission. This is a modification of an existing device; no new training of an AI model is described. The original AiCE training set (if applicable) would have been used for the predicate or earlier versions.

8. How the ground truth for the training set was established:

   • Not applicable for this submission as no new training set is mentioned.

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