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The MRI system is 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. 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 new Vantage Titan (Model MRT-1504/U4) MRI System is comparable to the current 1.5T Vantage Titan MRI System. The Vantage Titan uses the same magnet as the current Vantage Titan (K080038). However, the following modifications have been added: a redefinition of gradient strength, magnet cover and cabinet's configuration changes. In addition, two applications software: Diffusion Tensor Tractography (DTT), and PaceMaker.

This 510(k) premarket notification describes modifications to an existing MRI system (Vantage Titan) rather than a new AI medical device requiring extensive performance studies. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence to predicate devices and adherence to established safety and performance standards for MRI systems, rather than clinical performance metrics for an AI algorithm.

Here's a breakdown of the provided information, framed to address your questions where possible:

Acceptance Criteria and Reported Device Performance

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Vantage Titan 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 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 us 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 (K102489). MRA (MR Angio) software package which functions are same as the MRA package of existing 1.5T MRI Vantage Titan (K080038) is added to Vantage Titan 3T.

The provided document is a 510(k) summary and FDA clearance letter for a Magnetic Resonance Diagnostic Device, the Toshiba Vantage Titan 3T (MRT-3010/A5). It primarily focuses on demonstrating substantial equivalence to a predicate device and safety parameters, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly for AI-related metrics like standalone performance, MRMC studies, sample sizes for test/training sets, and expert-established ground truth, is not present in the provided text. The submission is for an MRI system and its software packages, not an AI/CADe device that typically undergoes such performance evaluations.

Here's a breakdown of what can and cannot be answered based on the input:

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

The document does not specify performance-based acceptance criteria in the way one would for a diagnostic accuracy study. Instead, it details safety parameters to show equivalence to a predicate device.

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The MRI system is 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. 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 HSR (Model MRT-1504/A5) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan HSR uses the same magnet as the existing Vantage Titan (K080038). It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan HSR provides the maximum field of view of 55 x 55 x 55 cm.

The provided text describes a 510(k) premarket notification for the Toshiba Vantage Titan HSR MRI system, focusing on its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, device performance metrics, or a study designed to prove the device meets these criteria in the manner requested.

The document details safety parameters and imaging performance but only states:

• Imaging Performance Parameters: "No change from the previous predicate submission (K080038)."
• Testing: "Testing was done in accordance with applicable recognized consensus standards as listed below. Additionally, human volunteer studies (in Japan) were conducted to verify imaging performance."

This indicates that the primary method for demonstrating device effectiveness and safety was through showing substantial equivalence to an existing device, rather than through a new, specific performance study with defined acceptance criteria. The "human volunteer studies" are mentioned very generally without details on design, metrics, or results.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance through substantial equivalence, hardware/software changes, and safety standards, not on a detailed clinical or performance study with acceptance criteria and results.

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