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The MRI 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. In addition, this system supports non-contrast 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 with Helios gradient (Model MRT-1504/U5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan with Helios gradient uses the same magnet as the Vantage Titan (K120638). The gradient performance was modified using. the same gradient amplifier and gradient coil as Vantage Titan HSR (K112003).

The provided text describes a 510(k) premarket notification for a modified MRI device (Vantage Titan with Helios gradient, model MRT-1504/U5). However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria for device performance studies and the specifics of those studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

The submission focuses on establishing substantial equivalence to previously cleared predicate devices (K120638: Vantage Titan, K112003: Vantage Titan HSR) by highlighting hardware and software modifications and confirming safety parameters and imaging performance are maintained.

Here's a breakdown of what can be answered based on the provided text:

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

The document does not explicitly state "acceptance criteria" for imaging performance in a quantifiable way beyond affirming "Imaging Quality metrics utilizing phantoms are provided in this submission." Instead, it compares safety parameters to the predicate devices and states "No change from the previous predicate submission (K120638)." regarding imaging performance parameters.

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 states "Image Quality metrics utilizing phantoms are provided in this submission" and mentions "testing of the modified system was conducted in accordance with the applicable standards." However, it does not provide details on:

• The specific sample size of phantoms used.
• Whether any human subject data (test set) was used, and if so, its size or provenance (country of origin, retrospective/prospective). The studies appear to be primarily engineering validation based on standards and phantom imaging.

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. The focus is on technical performance specifications and substantial equivalence, not diagnostic accuracy studies involving expert interpretation of images for ground truth.

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

This information is not provided in the document, as no human-read test set requiring adjudication is described.

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

An MRMC study is not mentioned in the document. The device is an MRI system, not an AI-powered diagnostic tool, so such a study would not be expected or relevant to this submission.

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

This refers to AI algorithm performance. The device is an MRI system, not an AI diagnostic algorithm, so this is not applicable and not mentioned.

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

For the "Image Quality metrics utilizing phantoms," the ground truth would likely be established metrologically or by predefined physical properties of the phantoms.
For safety parameters, the ground truth would be the measurement against established safety standards (e.g., IEC 60601-2-33). No clinical ground truth (expert consensus, pathology, outcomes) is described.

8. The sample size for the training set

This is not applicable as the device is an MRI hardware system, not an AI model that requires a training set.

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

This is not applicable as the device is an MRI hardware system, not an AI model that requires a training set.

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