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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

Study Information (as applicable to this device modification):

1. Sample size used for the test set and the data provenance:

   • Test Set: Not applicable in the sense of a clinical trial with patient data to evaluate an AI algorithm's performance. The "testing" referred to in this submission is related to engineering verification and validation of hardware and software changes, and demonstrating compliance with safety and performance standards. This would involve internal testing, phantom studies, and potentially a limited number of human scans to confirm functionality and safety, but not a large-scale clinical test set for diagnostic accuracy.
   • Data Provenance: Not specified for a clinical test set. The validation would have been performed by Toshiba Medical Systems Corporation, likely in Japan (manufacturing site).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is not a study establishing ground truth for a diagnostic AI algorithm. The safety and performance evaluations would involve engineers and potentially clinical experts to review images and system functionality, but not in the capacity of creating a "ground truth" for a diagnostic accuracy study.

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

   • Not applicable for the type of submission. Adjudication methods are typically for clinical trials assessing diagnostic accuracy, which is not the focus here.

4. 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. This submission is for modifications to an MRI scanner and the addition of specific imaging sequences (DTT, PaceMaker), not for an AI-assisted diagnostic tool requiring a MRMC study.

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

   • No. The "applications software" (DTT and PaceMaker) are features of the MRI system, designed to aid in image acquisition and processing, not standalone diagnostic algorithms.

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

   • Not applicable in the context of diagnostic "ground truth." For hardware and software functionality, ground truth would be established through engineering specifications, phantom measurements, and known physical principles. For the new software features (DTT, PaceMaker), ground truth would relate to their ability to correctly perform their intended function (e.g., generate diffusion tensor tracts, accurately gate cardiac images) as measured against established technical benchmarks and clinical expectations.

7. The sample size for the training set:

   • Not applicable. This device is not an AI algorithm that learns from a training set of labeled data in the conventional sense. The "training" for the software applications would be their development and optimization by engineers.

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

   • Not applicable, as there isn't a "training set" in the context of an AI algorithm learning from data. The functionality of DTT and PaceMaker would be based on well-established MR physics and clinical needs.

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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.

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

This information is not provided in the document as it's not a clinical performance study in the context of diagnostic accuracy. The testing mentioned refers to design control activities and conformity with standards, not performance on patient data.

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. The submission does not detail a study involving expert establishment of ground truth for a test set.

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

This information is not provided.

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 was not mentioned or performed for this submission. The device is an MRI system, not an AI or CADe product designed to assist human readers.

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

A standalone performance study of an algorithm was not mentioned or performed. The submission is for the MRI system itself.

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

This information is not provided. As an MRI system, its "truth" is typically its ability to generate images reflecting the a priori known physics of MRI and depicting anatomical structures. The document states, "When interpreted by a trained physician, these images yield information that can be useful in diagnosis," implying that the final diagnostic "truth" comes from physician interpretation of the images, not from an algorithm.

8. The sample size for the training set

This information is not applicable and not provided. The device is an MRI machine with software packages, not a machine learning model that requires a training set of patient data in the typical sense.

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

This information is not applicable and not provided.

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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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