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The Vantage Titan system is 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 K150427. 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.

The provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or a formal study proving the device meets acceptance criteria in the way a clinical trial report would.

The document is a 510(k) summary for a software update to an MRI system (Vantage Titan 1.5T, MRT-1510, V3.6 Software). It asserts substantial equivalence to predicate devices based on safety and effectiveness, and highlights software changes and various testing activities.

Here's a breakdown of the available information in response to your questions:

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

The document does not provide a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative reported device performance values. Instead, it states that:

• Safety Parameters: The device's safety parameters (Static field strength, Operational Modes, SAR dB/dt display, Operating mode access requirements, Maximum SAR, Maximum dB/dt, Potential emergency condition and means provided for shutdown) are "Same" as the predicate device (Vantage Titan 1.5T, V3.1 (K150427)).
• Imaging Performance Parameters: There is "No change from the previous predicate submission, K150427."
• Conclusion: "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."

This indicates that the acceptance criteria for these aspects were likely the maintenance of equivalence to the predicate device's established performance and safety profiles. However, the exact quantitative criteria are not disclosed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing, phantom imaging, volunteer clinical imaging" but does not specify the sample size for human subjects (volunteers) or the data provenance (country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. It speaks generally about "Images ... when interpreted by a trained physician," but no details on experts for ground truth establishment.

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

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study or any AI assistance for human readers. The software updates primarily concern new pulse sequences and automatic positioning assistance (NeuroLine+, CardioLine+, SureVOI), which enhance image acquisition and planning, not necessarily image interpretation by a human reader in an AI-assisted workflow.

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

This document describes an MRI system's software update, which is a diagnostic imaging modality. It does not refer to a standalone algorithm for diagnosis without human-in-the-loop performance. The indications state that images "yield information that can be useful in diagnosis" when "interpreted by a trained physician."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for specific performance evaluations. Given the nature of MRI systems, it would typically involve clinical assessments, expert review of images, and potentially correlation with other diagnostic modalities or pathology where applicable, but this is not detailed here.

8. The sample size for the training set

The document does not specify a training set size. The software changes involve new pulse sequences and automatic positioning assistance, which would be developed and validated through a combination of engineering testing, phantom studies, and "volunteer clinical imaging," but a distinct "training set" per machine learning terminology is not mentioned.

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

Since a training set with explicitly established ground truth (in the machine learning sense) is not described, this information is not provided.

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