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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

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 Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K143008. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

Here's an analysis of the provided text regarding acceptance criteria and study details:

Overall Assessment: The provided document is a 510(k) summary for a software modification to an existing MRI system (Vantage Titan 3T, MRT-3010/A5, V2.50). It focuses primarily on demonstrating substantial equivalence to the previously cleared version, with the addition of "mART" and "mART+" functionalities (Metal Artifact Reduction Technique and mART with View Angle Tilting).

Crucially, this document does not contain explicit, quantitative acceptance criteria for device performance in the context of metal artifact reduction, nor does it detail a clinical study with a specified sample size, expert readers, or ground truth establishment in the manner typically expected for a new diagnostic claim. Instead, it relies on demonstrating that the new functionalities do not alter the existing indications for use and that they are safe and effective through bench and volunteer imaging.

Below is a breakdown based on your requested information, highlighting what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria with corresponding reported performance values are not provided in this 510(k) summary. The document states: "Bench testing utilizing both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images." This is a qualitative statement of capability rather than a measurable acceptance criterion.

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

• Sample Size: Not specified. The document mentions "phantom and representative clinical images" and "volunteer clinical imaging" but does not quantify the number of images or volunteers.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the "representative clinical images" or "volunteer clinical imaging."
  • Retrospective or Prospective: Not explicitly stated. "Volunteer clinical imaging" would imply prospective acquisition for the purpose of the test, but the "representative clinical images" source is unclear.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: If experts were involved in assessing the "reduction of metal related artifacts," their role and qualifications are not detailed. The document only mentions that the images, "when interpreted by a trained physician," yield useful diagnostic information in general, not specifically for the evaluation of the mART features.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the lack of specified experts, a formal adjudication process is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described.
• Effect Size of Human Reader Improvement: Therefore, no effect size is reported. This submission focuses on a new imaging sequence feature (mART/mART+) rather than an AI-assisted diagnostic tool designed to directly improve human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable in the typical sense of a standalone algorithm for diagnostic interpretation. The mART and mART+ functionalities are image acquisition and reconstruction techniques integrated into the MRI system. Their "performance" is assessed by the quality of the resulting image, which is then interpreted by a human. The bench and phantom testing could be considered a form of standalone technical evaluation of the image quality improvement.

7. The Type of Ground Truth Used

• Ground Truth: For the "reduction of metal related artifacts," the implied ground truth seems to be visual qualitative assessment of image quality improvements in regions affected by metal. For phantom studies, the ground truth would be the known properties of the phantom and the presence/absence of metal. For "volunteer clinical imaging," a definitive "ground truth" to quantitatively measure artifact reduction is not explicitly described (e.g., an independent reference standard for quantifying artifact severity). The focus is on demonstrating the capability of the feature to reduce artifacts.

8. The Sample Size for the Training Set

• This information is not provided. As these are image acquisition/reconstruction techniques rather than a machine learning model for diagnosis, a "training set" in the conventional AI sense may not be directly applicable or explicitly detailed in this type of submission. If any machine learning components are involved in the mART/mART+ algorithms, the details of their training are not disclosed here.

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

• This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this 510(k) submission.

Summary of Missing Information:

This 510(k) summary for a modified MRI device primarily relies on demonstrating that new image acquisition/reconstruction features (mART and mART+) do not alter the existing indications for use, maintain safety parameters, and are qualitatively effective at reducing metal artifacts through bench and volunteer imaging. It does not provide detailed information on quantitative acceptance criteria, large-scale clinical studies with specific sample sizes, expert ground truth establishment, or human-in-the-loop performance improvements, which are more common requirements for submissions involving new diagnostic AI algorithms.

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