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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 vield information that can be useful in diagnosis

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System(K113093). Four software packages (Positioning Assist for Cardiac, Diffusion Tensor Tractography (DTT) , Cardiac Function Analysis, and Image filter EM AIDR are added to Vantage Titan 3T.

The provided text is a 510(k) summary for the Toshiba Vantage Titan 3T, v2.0 (MRT-3010/A5) MRI system. It describes the device and its intended use, focusing on software package additions to an already cleared predicate device (K113093). The document primarily addresses safety parameters and outlines the process of demonstrating substantial equivalence to the predicate device, especially regarding design control activities and adherence to recognized standards.

However, the document does not contain the specific information required to complete the table for acceptance criteria and device performance, nor does it provide details about a study designed to prove the device meets specific acceptance criteria in the way described in the prompt.

Here's why and what information can be extracted or inferred:

• Acceptance Criteria and Reported Device Performance: This section is not explicitly present. The document focuses on showing the new device is "substantially equivalent" to a predicate device by comparing safety parameters (which are identical) and outlining that the new software additions are consistent with the predicate's intended use. It doesn't define new performance-based acceptance criteria for the added software packages (Positioning Assist for Cardiac, DTT, Cardiac Function Analysis, Image filter EM AIDR) nor report specific performance metrics against such criteria.
• Study Design Information: The document states, "The test methods used are the same as those submitted in the previously cleared submissions (K113093). A declaration of conformity with design controls is included in this submission." This indicates that the validation relied on existing testing methodologies and design controls from the predicate device, rather than a new standalone study with a defined sample size, ground truth, experts, or adjudication methods for the specific software additions.

Therefore, the table and most of the detailed study questions cannot be answered from the provided text.

Inference/Extracted Information based on the provided text:

While a direct study with acceptance criteria is not detailed, the text implies that the "acceptance criteria" for the new software features were essentially demonstrating that they maintained the overall safety and imaging performance of the predicate device and performed their described functions as intended, within the framework of existing design controls. The study that "proves" this is the demonstration of substantial equivalence to the predicate device K113093, adhering to international standards for MR devices and software development.

Summary of what can be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated for the new software features. The document states: "The test methods used are the same as those submitted in the previously cleared submissions (K113093)." This implies reliance on the testing performed for the predicate device, but no specifics are given for the validation of the new software additions.

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):

• Not stated. The document does not detail specific expert-based evaluations for validating the new software features.

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

• Not stated.

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 is not mentioned. The document describes software additions (Positioning Assist, DTT, Cardiac Function Analysis, an image filter AIDR), which are enhancements to an existing MRI system, not AI-assisted diagnostic tools requiring a reader study of this nature. "Image filter EM AIDR" is mentioned, which is an "image filter which can reduce the ringing artifact especially in low resolution images," this is a technical image processing feature, not necessarily an AI for diagnostic interpretation.

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

• Not explicitly stated for the new software features in the context of performance metrics. The software changes are described as functional additions. The image filter would operate in a standalone manner on image data, but performance metrics for it are not provided here.

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

• Not explicitly stated for the new software features. Given the nature of the software (positioning assist, DTI visualization, cardiac function analysis, image filter), ground truth would likely be based on physical phantom measurements, simulated data, and comparison to established clinical norms or pre-existing validated methods for the DTT and Cardiac Function Analysis.

8. The sample size for the training set:

• Not applicable/Not stated. The software additions are described as functional packages and an image filter, not explicitly as machine learning algorithms that would require a "training set" in the common sense for AI/ML models.

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

• Not applicable/Not stated. (See point 8).

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