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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

Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K143008. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display cross-sectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.

Here's an analysis of the provided text regarding acceptance criteria and study details:

Overall Assessment: The provided document is a 510(k) summary for a software modification to an existing MRI system (Vantage Titan 3T, MRT-3010/A5, V2.50). It focuses primarily on demonstrating substantial equivalence to the previously cleared version, with the addition of "mART" and "mART+" functionalities (Metal Artifact Reduction Technique and mART with View Angle Tilting).

Crucially, this document does not contain explicit, quantitative acceptance criteria for device performance in the context of metal artifact reduction, nor does it detail a clinical study with a specified sample size, expert readers, or ground truth establishment in the manner typically expected for a new diagnostic claim. Instead, it relies on demonstrating that the new functionalities do not alter the existing indications for use and that they are safe and effective through bench and volunteer imaging.

Below is a breakdown based on your requested information, highlighting what is and is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit quantitative acceptance criteria with corresponding reported performance values are not provided in this 510(k) summary. The document states: "Bench testing utilizing both phantom and representative clinical images were obtained to demonstrate the subject device is capable of reducing metal related artifacts on MR images." This is a qualitative statement of capability rather than a measurable acceptance criterion.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document mentions "phantom and representative clinical images" and "volunteer clinical imaging" but does not quantify the number of images or volunteers.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the "representative clinical images" or "volunteer clinical imaging."
  • Retrospective or Prospective: Not explicitly stated. "Volunteer clinical imaging" would imply prospective acquisition for the purpose of the test, but the "representative clinical images" source is unclear.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: If experts were involved in assessing the "reduction of metal related artifacts," their role and qualifications are not detailed. The document only mentions that the images, "when interpreted by a trained physician," yield useful diagnostic information in general, not specifically for the evaluation of the mART features.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the lack of specified experts, a formal adjudication process is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described.
• Effect Size of Human Reader Improvement: Therefore, no effect size is reported. This submission focuses on a new imaging sequence feature (mART/mART+) rather than an AI-assisted diagnostic tool designed to directly improve human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This is not applicable in the typical sense of a standalone algorithm for diagnostic interpretation. The mART and mART+ functionalities are image acquisition and reconstruction techniques integrated into the MRI system. Their "performance" is assessed by the quality of the resulting image, which is then interpreted by a human. The bench and phantom testing could be considered a form of standalone technical evaluation of the image quality improvement.

7. The Type of Ground Truth Used

• Ground Truth: For the "reduction of metal related artifacts," the implied ground truth seems to be visual qualitative assessment of image quality improvements in regions affected by metal. For phantom studies, the ground truth would be the known properties of the phantom and the presence/absence of metal. For "volunteer clinical imaging," a definitive "ground truth" to quantitatively measure artifact reduction is not explicitly described (e.g., an independent reference standard for quantifying artifact severity). The focus is on demonstrating the capability of the feature to reduce artifacts.

8. The Sample Size for the Training Set

• This information is not provided. As these are image acquisition/reconstruction techniques rather than a machine learning model for diagnosis, a "training set" in the conventional AI sense may not be directly applicable or explicitly detailed in this type of submission. If any machine learning components are involved in the mART/mART+ algorithms, the details of their training are not disclosed here.

9. How the Ground Truth for the Training Set Was Established

• This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this 510(k) submission.

Summary of Missing Information:

This 510(k) summary for a modified MRI device primarily relies on demonstrating that new image acquisition/reconstruction features (mART and mART+) do not alter the existing indications for use, maintain safety parameters, and are qualitatively effective at reducing metal artifacts through bench and volunteer imaging. It does not provide detailed information on quantitative acceptance criteria, large-scale clinical studies with specific sample sizes, expert ground truth establishment, or human-in-the-loop performance improvements, which are more common requirements for submissions involving new diagnostic AI algorithms.

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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 yield information that can be useful in diagnosis.

The Vantage Titan (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K152371. This system is based upon the technology, software 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 document does not contain information about specific acceptance criteria, a study proving device conformance to those criteria, or details regarding the performance of the device against such criteria. The document is a 510(k) premarket notification for a Magnetic Resonance Imaging (MRI) system (Vantage Titan 3T, MRT-3010/A7, M-Power GX).

Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices by outlining:

• Device Description and Changes: The submission describes the MRI system and lists software functionalities being migrated from existing cleared devices (sequence enhancements, post-processing enhancements, R-wave detection improvement).
• Safety Parameters: It compares safety parameters (static field strength, operational modes, SAR, dB/dt, emergency shutdown) of the subject device with the primary predicate device, noting they are the "Same."
• Imaging Performance Parameters: It explicitly states "No change from the previous predicate submission, K152371," indicating that the imaging performance is considered equivalent to the cleared predicate and not re-evaluated with new acceptance criteria or studies.
• Indications for Use: No changes to the previously cleared indications for use.
• Design Control Activities: Mentions risk management activities for new software functionalities and pulse sequences, confirming the test methods are the same as those in previously cleared submissions and indicating conformity with design controls.
• Safety and Standards Conformance: States the device is designed and manufactured under Quality System Regulations and ISO 13485, and conforms to applicable IEC and NEMA standards.
• Software Documentation: References FDA guidance for software documentation for a moderate level of concern.
• Conclusion: Concludes that "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."

Therefore, I cannot provide the requested table or detailed information on specific studies, sample sizes, expert qualifications, or adjudication methods related to specific acceptance criteria and device performance as this document addresses substantial equivalence rather than a new standalone performance evaluation against defined acceptance criteria. The "testing" mentioned is implicitly related to software validation and risk management applied to changes, assuming the underlying hardware and core imaging performance already met acceptance criteria in prior submissions.

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Vantage Titan 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 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 K160632. 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.

This document is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system, model MRT-1510, with V4.0 software. It details the modifications to a previously cleared device and asserts substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document does not explicitly state specific acceptance criteria (performance targets/thresholds) for the new software functionalities. Instead, it focuses on demonstrating that the modified device remains safe and effective for its intended use, which is to produce diagnostic MRI images. The testing outlined aims to show that the new functionalities perform as expected and do not compromise the device's safety or the quality of the diagnostic images compared to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria are not provided, this table will reflect the types of tests performed and the general conclusions rather than specific numerical targets.

Study Details

The document describes the testing performed to support the substantial equivalence claim, primarily focusing on general types of testing rather than a specific clinical study with detailed methodology as one might expect for a novel diagnostic algorithm.

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "volunteer clinical imaging" but does not specify the number of volunteers or cases.
   • Data Provenance: The document implies testing was conducted by Toshiba Medical Systems Corporation (TMSC) in Japan and/or Toshiba America Medical Systems (TAMS) in the USA, as these are the manufacturing and applicant/US agent locations. The data would likely be prospective as it involves "volunteer clinical imaging" and phantom/bench testing of the new V4.0 software.

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

   • Not specified. The document states "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." However, it does not detail the number or qualifications of physicians involved specifically in establishing ground truth for the testing described in this submission.

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

   • Not specified.

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, an MRMC comparative effectiveness study is not mentioned in this document. The submission is for a modification to an MRI system's software adding new pulse sequences and functionalities, not for an AI diagnostic algorithm that assists human readers.

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

   • The term "standalone performance" isn't directly applicable in the context of an MRI system's pulse sequences. The performances described (bench testing, phantom imaging, volunteer clinical imaging) are for the imaging capabilities of the device itself, which generates images for human interpretation. The algorithms are part of the image generation process, not a separate diagnostic tool. The document focuses on the system's performance rather than a specific AI algorithm's diagnostic accuracy in isolation.

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

   • Not explicitly stated. Given the nature of MRI system validation, ground truth would typically be established by expert radiologists interpreting the images from "volunteer clinical imaging" and comparing them to expected anatomical structures or known pathological conditions (if applicable to the volunteers). For phantom imaging, the 'ground truth' is the known physical properties and configurations of the phantom.

7. The sample size for the training set:

   • Not applicable / Not specified. This submission is for an MRI system's software update, introducing new pulse sequences and image processing enhancements. It does not describe a machine learning algorithm that requires a "training set" in the conventional sense for a diagnostic AI. The software development and validation process would involve iterative testing and refinement, but not a distinct "training set" for an AI model as typically understood in AI/ML submissions.

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

   • Not applicable / Not specified. As there is no mention of a "training set" for an AI model, this question does not apply.

Ask a specific question about this device

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.

Ask a specific question about this device

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 yield information that can be useful in diagnosis.

The Vantage Titan 3T (Model MRT-3010) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K143008. This submission will include the following software functionalities: UTE (Ultra Short TE), MP-RAGE, T2:mEcho, T2*:mEcho, Improvements to MRS, Multi b-value DWI, SpineLine+, SureVOI, 2D Real-time Motion Correction (2D-RMC) and eFSBB.

Here's a breakdown of the acceptance criteria and study information for the Vantage Titan 3T (MRT-3010) MRI system, based on the provided document.

It's important to note that this document is a 510(k) summary for a software update to an existing MRI system. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating that the new software functionalities do not introduce new safety or effectiveness concerns and that the system continues to perform as specified, maintaining substantial equivalence to its predicate device. This is often validated through technical performance parameters rather than clinical diagnostic accuracy per se in these types of submissions.

1. Table of Acceptance Criteria and Reported Device Performance

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Vantage Titan 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 yield information that can be useful in diagnosis.

The Vantage Titan (Model MRT-1510) is a 1.5 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan uses 1.4m short and 4.1 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the whole body coil of the Vantage Titan provides the maximum field of view of 55 x 55 x 50 cm. The Vantage Titan MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K120638), cleared Jun 1, 2012 with the following modifications.

The provided text is a 510(k) summary for the Toshiba Vantage Titan 1.5T MRI system. This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a detailed study proving the device meets specific performance criteria through clinical trials or statistical analysis of diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (especially those related to diagnostic accuracy, human-AI collaboration, or detailed ground truth establishment) are not available in this document.

However, based on the information provided, here's what can be extracted:

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

The document doesn't explicitly list "acceptance criteria" in the traditional sense of diagnostic performance thresholds for an AI/CAD system. Instead, it focuses on demonstrating that the new Vantage Titan 1.5T MRI system maintains the safety and effectiveness of its predicate device, primarily through technical specifications and adherence to standards. The "performance" reported is related to maintaining safety and imaging capabilities without raising new safety or effectiveness concerns.

2. Sample sized used for the test set and the data provenance

The document mentions "archived clinical images, simulation testing and bench (phantom) testing" were used for testing (Section 13). However, it does not provide any specific sample sizes for these tests or information on the provenance (e.g., country of origin, retrospective/prospective nature) of the "archived clinical images."

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

This information is not provided in the document. For a diagnostic imaging device like an MRI, the "ground truth" for its output (images) is generally understood to be the accurate representation of anatomical structures and their properties, which is then interpreted by a "trained physician" as stated in the Indications for Use (Section 2 and 10). The document does not describe a study involving expert readers establishing ground truth for a test set in the context of diagnostic accuracy assessment for the device as a whole.

4. Adjudication method 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

A MRMC comparative effectiveness study was not done or at least not described in this document. This submission is for an MRI system itself, not an AI/CAD system that assists human readers.

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

This is not applicable as the device is an MRI scanner, a diagnostic imaging modality, not an algorithm for standalone diagnosis. Its output (images) requires interpretation by a trained physician.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic AI systems (e.g., expert consensus, pathology) is not directly applicable in the context presented. For an MRI system, the "ground truth" that it aims to capture is the physical reality of the internal anatomical structures and their NMR properties. The device's performance is gauged by its ability to produce clear, accurate, and consistent images that, when interpreted by a trained physician, yield useful diagnostic information. The testing mentioned (archived clinical images, simulation, bench/phantom testing) would implicitly rely on established methods to verify the accuracy and quality of the generated images against physical or known standards.

8. The sample size for the training set

This information is not provided. The document describes testing of modifications to an existing MRI system, not the training of a new AI model with a specific training set.

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

This information is not provided and is not applicable in the context of this 510(k) submission for an MRI machine where "training set" doesn't refer to an AI model's learning data.

Ask a specific question about this device

Vantaqe 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 maqnetic 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 aqent use is restricted to the approved druq indications. When interpreted by a trained physician, these imaqes yield information that can be useful in diagnosis.

The Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K132160. This submission includes WFS (Water Fat Separation) software functionality and the optional subsystem, Saturn Gradient Option.

The provided text is a 510(k) summary for the Toshiba Medical Systems Corporation's Vantage Titan 3T Magnetic Resonance Imaging (MRI) System. This submission is for modifications to an already cleared device, specifically adding WFS (Water Fat Separation) software functionality and an optional Saturn Gradient Option. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the new features meet specific clinical acceptance criteria.

However, I can extract information related to acceptance criteria and the type of study conducted for the new features, even if it doesn't detail specific performance metrics against clinical thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative thresholds for clinical performance or corresponding reported device performance metrics for the WFS software functionality or the Saturn Gradient Option.

Instead, the submission states:

• "This testing demonstrated that the software performed as specified and did not raise new issues of safety and effectiveness."
• "The additional software packages are work flow improvements and their performance was demonstrated to be equal to or better than the current methods for obtaining the same results."

These statements indicate that the "acceptance criteria" for these new features were likely focused on:

• Functionality: The WFS software correctly separates water and fat images as intended.
• Safety: No new safety concerns are introduced by the changes.
• Equivalence/Non-inferiority: Performance is at least as good as, or better than, existing methods or the predicate device's performance for the same tasks.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document only mentions "representative volunteer images" for the WFS software functionality. No specific number for the volunteer images or phantom studies is provided.
• Data Provenance: Not explicitly stated, but typically, testing for such devices is conducted by the manufacturer, often using their own facilities or clinical partners. The country of origin for the manufacturing site is Japan. The nature of the study (retrospective/prospective) is not specified, but for new feature validation, it would typically involve prospective data acquisition.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing ground truth for the "representative volunteer images" or phantom studies. However, the "Indications for Use" section mentions that images are "interpreted by a trained physician," implying that expert interpretation is crucial for diagnostic use. For the validation of image quality, typically radiologists or other medical imaging specialists would be involved.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for evaluating the test set for the new features.

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

This submission is for an MRI system with new software features, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with/without AI assistance is not applicable and was not performed. The "WFS (Water Fat Separation)" functionality is an image processing technique, not an AI interpretation tool.

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

Yes, in a sense. The testing for the WFS software itself, particularly the "phantom studies," would constitute an evaluation of the algorithm's performance in a standalone manner, assessing its ability to correctly separate water and fat signals. The "representative volunteer images" would also assess the algorithm's performance on human data, but the evaluation of these images would implicitly involve a human observer (e.g., to confirm visual quality and separation). The document states, "This testing demonstrated that the software performed as specified," implying that the software's output was directly evaluated.

7. The Type of Ground Truth Used

• Phantom Studies: For phantom studies, the ground truth is typically known and engineered into the phantom itself (e.g., known fat/water ratios in different compartments). This provides an objective measure of the algorithm's accuracy in separating these components.
• Volunteer Images: For "representative volunteer images," the ground truth would likely be established through visual assessment by experts (e.g., confirming clear water/fat separation, absence of artifacts, and diagnostic quality) or potentially by comparing with established imaging sequences known to provide good fat/water separation. Pathology or outcomes data would not be the direct ground truth for this type of image processing feature.

8. The Sample Size for the Training Set

The document does not provide any information about a training set since the WFS functionality and gradient option are described as "software functionality" and "optional subsystem" being added to an existing, cleared MRI system. It does not suggest these features involved a machine learning model that required a specific training set in the conventional sense. If the WFS algorithm development involved any iterative refinement, details are not provided here.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for a machine learning model, this question is not applicable based on the provided text.

Ask a specific question about this device

Vantaqe Titan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display analomic 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 mağnetic 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 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System and was cleared under K120487. This submission will include the following five software functionalities: Changes in the SAR calculation method, 3D ASL (3 dimensional Arterial Spin Labeling), Advanced Moving Bed (AMB), 3D MRS (3 dimensional MR Spectroscopy) and Distortion correction for entire volume are added to Vantage Titan 3T.

Analysis of K132160 for Acceptance Criteria and Study Details

The provided document K132160 relates to a 510(k) premarket notification for software functionalities added to the Toshiba Vantage Titan 3T MRI system (Model MRT-3010/A5). It's important to note that this submission primarily concerns software changes and their impact on safety and performance parameters, rather than a new diagnostic algorithm or a comparative effectiveness study for a new clinical indication. Therefore, the typical structure for reporting acceptance criteria and study details for an AI/algorithm-driven diagnostic device showing clinical performance metrics may not fully apply in this context.

Based on the document, the "acceptance criteria" and "device performance" are primarily framed around compliance with established safety standards and maintaining equivalence in imaging performance compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for software updates to an existing MRI system, the acceptance criteria are largely focused on demonstrating that the updated system continues to meet safety and performance standards, or improves on flexibility without compromising safety. There aren't specific quantitative accuracy metrics for diagnosing a condition, but rather operational and safety specifications.

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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.

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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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