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Vantage Galan 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 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 Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K181593. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

The provided text is a 510(k) summary for the Canon Medical Systems Corporation's Vantage Galan 3T, MRT-3020, V6.0 MRI System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the requested information elements (1, 2, 3, 4, 5, 7, 8, 9) regarding acceptance criteria, sample sizes, expert qualifications, ground truth establishment, and MRMC effectiveness studies cannot be fully extracted from this document as it is not a study report for an AI device.

However, based on the information provided regarding the "Compressed SPEEDER" feature, which is a new software functionality, I can deduce some aspects related to its evaluation.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

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

• Sample Size:
  • For technical image quality metrics (SNR, unfolding error, phase encode performance): Phantoms and volunteer images were used. The exact number of phantoms or volunteers is not specified.
  • For clinical image quality assessment by radiologists: Representative images were obtained using the subject device. The exact number of images or cases is not specified.
• Data Provenance: Not explicitly stated, but given it's a medical device submission by a Japanese company with a U.S. agent, the volunteer imaging likely occurred either in Japan or the US. This was a prospective evaluation of the new software feature.

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

• Number of experts: Not explicitly stated, but referred to as "American Board Certified Radiologists" (plural), indicating at least two.
• Qualifications of experts: "American Board Certified Radiologists." No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication method for the test set

• The document states that reviewers (radiologists) "provided detailed assessments." It does not specify an adjudication method (e.g., 2+1, 3+1, none) for reaching a consensus on the diagnostic quality or other assessments if multiple radiologists were involved. It simply says "reviewed by American Board Certified Radiologists."

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, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human reader improvement with AI assistance. The evaluation focused on the diagnostic quality of images produced by the device's new "Compressed SPEEDER" and "T2 Map" features, reviewed by radiologists, rather than comparing human reader performance with and without AI assistance from these features. The device's features (Compressed SPEEDER) are about image acceleration and quality, not necessarily AI for diagnostic assistance to humans.

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

• Yes, a standalone evaluation of the "Compressed SPEEDER" algorithm's technical performance was done using phantoms and volunteer images to assess SNR, unfolding error artifacts, and performance in all phase encode directions. The algorithm's output (images) was then assessed for diagnostic quality by radiologists. This refers to the algorithm generating the images, which are then interpreted.

7. The type of ground truth used

• For the technical image quality metrics (SNR, unfolding error, phase encode performance), the ground truth was based on known phantom dimensions and electromagnetic properties, along with expected image characteristics from volunteer scans.
• For the clinical assessment by radiologists, the ground truth was expert consensus (implied, as radiologists reviewed and confirmed diagnostic quality). No mention of pathology or outcomes data as ground truth is made.

8. The sample size for the training set

• The document does not specify a training set size or methodology. It is a 510(k) summary for a software update to an MRI system, not a detailed algorithm development report. It is likely that the Compressed SPEEDER algorithm was developed and trained internally by Canon Medical Systems, but details are not provided here.

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

• As the training set itself is not mentioned, the method for establishing its ground truth is not provided in this document.

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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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Vantage Titan 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-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K160632. This system is based upon the technology 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.

This document is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system, model MRT-1510, with V4.0 software. It details the modifications to a previously cleared device and asserts substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document does not explicitly state specific acceptance criteria (performance targets/thresholds) for the new software functionalities. Instead, it focuses on demonstrating that the modified device remains safe and effective for its intended use, which is to produce diagnostic MRI images. The testing outlined aims to show that the new functionalities perform as expected and do not compromise the device's safety or the quality of the diagnostic images compared to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria are not provided, this table will reflect the types of tests performed and the general conclusions rather than specific numerical targets.

Study Details

The document describes the testing performed to support the substantial equivalence claim, primarily focusing on general types of testing rather than a specific clinical study with detailed methodology as one might expect for a novel diagnostic algorithm.

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "volunteer clinical imaging" but does not specify the number of volunteers or cases.
   • Data Provenance: The document implies testing was conducted by Toshiba Medical Systems Corporation (TMSC) in Japan and/or Toshiba America Medical Systems (TAMS) in the USA, as these are the manufacturing and applicant/US agent locations. The data would likely be prospective as it involves "volunteer clinical imaging" and phantom/bench testing of the new V4.0 software.

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

   • Not specified. The document states "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." However, it does not detail the number or qualifications of physicians involved specifically in establishing ground truth for the testing described in this submission.

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

   • Not specified.

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, an MRMC comparative effectiveness study is not mentioned in this document. The submission is for a modification to an MRI system's software adding new pulse sequences and functionalities, not for an AI diagnostic algorithm that assists human readers.

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

   • The term "standalone performance" isn't directly applicable in the context of an MRI system's pulse sequences. The performances described (bench testing, phantom imaging, volunteer clinical imaging) are for the imaging capabilities of the device itself, which generates images for human interpretation. The algorithms are part of the image generation process, not a separate diagnostic tool. The document focuses on the system's performance rather than a specific AI algorithm's diagnostic accuracy in isolation.

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

   • Not explicitly stated. Given the nature of MRI system validation, ground truth would typically be established by expert radiologists interpreting the images from "volunteer clinical imaging" and comparing them to expected anatomical structures or known pathological conditions (if applicable to the volunteers). For phantom imaging, the 'ground truth' is the known physical properties and configurations of the phantom.

7. The sample size for the training set:

   • Not applicable / Not specified. This submission is for an MRI system's software update, introducing new pulse sequences and image processing enhancements. It does not describe a machine learning algorithm that requires a "training set" in the conventional sense for a diagnostic AI. The software development and validation process would involve iterative testing and refinement, but not a distinct "training set" for an AI model as typically understood in AI/ML submissions.

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

   • Not applicable / Not specified. As there is no mention of a "training set" for an AI model, this question does not apply.

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