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Vantage 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 Orian (Model MRT-1550) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Orian uses 1.4 m short and 4.1 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 50 cm. The Model MRT-1550/A3, A4, A7, A8 includes the standard 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. The Vantage Orian MRI System is comparable to the current 1.5T Vantage Orian MRI System (K193021), cleared June 3, 2020 with the following modifications.

The provided document is a 510(k) summary for the Vantage Orian 1.5T, MRT-1550, V6.0 MRI System. This submission is for modifications to an already cleared device (K193021) and primarily focuses on safety and performance parameters typical for an MRI system, rather than AI/algorithm-driven diagnostic performance.

The document states:

• "No change from the previous predicate submission, K193021." regarding "IMAGING PERFORMANCE PARAMETERS".
• "image quality testing was completed which demonstrated that the subject device meets predetermined acceptance criteria. Image quality metrics were performed to assess signal-to-noise ratio, two-dimensional geometric distortion, image uniformity, and slice thickness."

Therefore, the acceptance criteria and study detailed below relate to physical device performance and image quality, not an AI algorithm's diagnostic accuracy or effectiveness in clinical interpretation. Since this is an MRI system and not an AI-powered diagnostic device, many of the requested elements for AI/algorithm studies (like sample size for test sets and training sets, AI effect size on human readers, adjudication methods, number of experts for ground truth, etc.) are not applicable in the context of this 510(k) submission.

Here is the information directly applicable from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The tests described are "bench testing" and "image quality testing." These likely refer to tests conducted on phantoms or test objects, not human patient data. Therefore, details like data provenance or sample size of patient cases are not provided as they are not relevant to the type of testing performed for this device modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" here would relate to physical image quality measurements from phantoms or engineering specifications, not expert diagnostic consensus on patient images.

4. Adjudication Method

Not applicable. No expert adjudication process is described for the image quality testing details provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed/Not applicable. This is a 510(k) for an MRI system modification, not an AI diagnostic algorithm. The document makes no mention of studies involving human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device (MRI system), not an AI algorithm. The performance evaluation is for the system's ability to acquire images, not interpret them.

7. Type of Ground Truth Used

The ground truth for the image quality testing would be based on physical phantom measurements and engineering specifications for parameters like SNR, geometric distortion, uniformity, and slice thickness.

8. Sample Size for the Training Set

Not applicable. This is a hardware modification submission for an MRI system, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no AI algorithm training set, there's no ground truth established for it.

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Vantage Titan 3T 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-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K152371. This system is based upon the technology, software and materials of previously marketed Toshiba 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.

The provided document does not contain information about specific acceptance criteria, a study proving device conformance to those criteria, or details regarding the performance of the device against such criteria. The document is a 510(k) premarket notification for a Magnetic Resonance Imaging (MRI) system (Vantage Titan 3T, MRT-3010/A7, M-Power GX).

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices by outlining:

• Device Description and Changes: The submission describes the MRI system and lists software functionalities being migrated from existing cleared devices (sequence enhancements, post-processing enhancements, R-wave detection improvement).
• Safety Parameters: It compares safety parameters (static field strength, operational modes, SAR, dB/dt, emergency shutdown) of the subject device with the primary predicate device, noting they are the "Same."
• Imaging Performance Parameters: It explicitly states "No change from the previous predicate submission, K152371," indicating that the imaging performance is considered equivalent to the cleared predicate and not re-evaluated with new acceptance criteria or studies.
• Indications for Use: No changes to the previously cleared indications for use.
• Design Control Activities: Mentions risk management activities for new software functionalities and pulse sequences, confirming the test methods are the same as those in previously cleared submissions and indicating conformity with design controls.
• Safety and Standards Conformance: States the device is designed and manufactured under Quality System Regulations and ISO 13485, and conforms to applicable IEC and NEMA standards.
• Software Documentation: References FDA guidance for software documentation for a moderate level of concern.
• Conclusion: Concludes that "Based upon bench testing, phantom imaging, volunteer clinical imaging, successful completion of software validation and application of risk management and design controls, it is concluded that the subject device is safe and effective for its intended use."

Therefore, I cannot provide the requested table or detailed information on specific studies, sample sizes, expert qualifications, or adjudication methods related to specific acceptance criteria and device performance as this document addresses substantial equivalence rather than a new standalone performance evaluation against defined acceptance criteria. The "testing" mentioned is implicitly related to software validation and risk management applied to changes, assuming the underlying hardware and core imaging performance already met acceptance criteria in prior submissions.

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