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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.

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 (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.

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

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

The document does not specify a numerical sample size for a "test set" in the context of clinical images used for evaluation. It mentions "sample clinical images" were used, but no quantity or specific details on patients.

• Data Provenance: Not explicitly stated for specific images, but the testing was done by Toshiba Medical Systems Corporation (TMSC) in Japan. The nature of the submission (software update for an existing device) suggests a mix of internal testing data. It does not state if data was retrospective or prospective.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for any "clinical images" in the test set. Given the nature of a 510(k) for a software update to an MRI, the primary focus is on technical performance and maintaining equivalence, not necessarily a new clinical trial for diagnostic accuracy. Interpretation of "sample clinical images" would typically be done by radiologists, but no specifics are given here.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating the safety and effectiveness of new software functionalities against established standards and the predicate device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not a software device in the AI/CAD context. The device is an MRI system. The performance evaluated here relates to the technical capabilities of the MRI system itself and its software. The testing mentioned ("bench testing, phantom image studies") points to standalone technical performance evaluation of the system components and software, rather than an "algorithm only" in the sense of a diagnostic aid. The device is a diagnostic imaging modality intended to be interpreted by a trained physician (human-in-the-loop).

7. Type of Ground Truth Used

The ground truth or reference standard for this submission is primarily tied to:

• Technical Specifications: Conformance to safety and performance parameters outlined in recognized consensus standards like IEC 60601-2-33 (2010).
• Predicate Device Performance: The cleared performance of the predicate device (Vantage Titan 3T, V2.50 K143008) serves as the benchmark for "substantial equivalence."
• Expected Image Quality: For "phantom image studies" and "sample clinical images," the ground truth would be what is considered normal or acceptable image quality and diagnostic information for an MRI of that class. For specific new functionalities (e.g., UTE, MP-RAGE), the 'truth' is whether the sequences generate the expected image characteristics and capabilities for which they were designed.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. The functionalities described (e.g., pulse sequences, automatic positioning assistance, motion correction, filters) are typically developed and refined through engineering expertise, physics principles, and iterative testing rather than statistical training on a large dataset in the way a deep learning model would be.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is identified, the concept of establishing ground truth for it does not directly apply. The development of these MRI software features would involve:

• Engineering Specifications: Designed to meet specific technical requirements.
• Physics Principles: Based on the underlying physics of MRI.
• Expert Knowledge: Input from MRI physicists, engineers, and potentially experienced radiologists on desired image characteristics and workflow improvements.
• Internal Testing and Iteration: Continuous refinement based on bench testing and phantom images.

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.

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

The document does not specify a sample size for a test set in the context of clinical studies with patients/images for diagnostic accuracy. This is because the submission is for software updates to an MRI scanner rather than a diagnostic algorithm that analyzes images for a specific condition.

The "testing" mentioned refers to engineering verification and validation (V&V) of the software functionalities and safety parameters, which would typically involve phantom studies, limited human subject testing for comfort/safety, and functional testing on the device itself.

• Test Set Sample Size: Not applicable/not specified for diagnostic accuracy. Testing would be against technical specifications and safety standards, likely involving hardware and software in a controlled environment.
• Data Provenance: Not applicable for diagnostic image data. The "testing" pertains to the device functionality, and data would be generated from the device itself or phantoms for technical validation. The manufacturing site is in Japan (Toshiba Medical Systems Corporation).

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

This question is not applicable in the context of this 510(k) summary. The ground truth for this type of submission is typically adherence to engineering specifications, safety standards (e.g., SAR limits), and functional performance for image acquisition (e.g., sequence parameters, distortion correction effectiveness). These are validated through technical measurements and comparisons, not expert interpretation of diagnostic images for a clinical outcome.

4. Adjudication Method for the Test Set

Given that the "test set" here refers to technical validation against specifications and safety standards rather than a clinical diagnostic accuracy study, adjudication methods like 2+1 or 3+1 are not applicable. The testing would involve objective measurements and comparisons by engineers and possibly physicists to confirm compliance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done or reported in this summary. This type of study is relevant for evaluating the impact of a diagnostic AI algorithm on human reader performance. This submission is for software updates to an MRI scanner, which primarily affects how images are acquired and processed, not how a human interprets them using an AI assistant.

• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.

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

No, a standalone performance evaluation (in the sense of a diagnostic algorithm without human input) was NOT done or reported. The device is an MRI scanner, which is an imaging modality. The software updates enhance the imaging capabilities (e.g., 3D ASL, 3D MRS, distortion correction). These are fundamental tools for image acquisition, not standalone diagnostic algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this submission is technical specifications, established safety limits (e.g., SAR limits from IEC standards), and the expected functional behavior of the software. This is verified through engineering testing, phantom studies, and comparison to the predicate device's established performance and indication of use. There is no mention of pathology, expert consensus on disease, or outcomes data as ground truth in this 510(k) summary.

8. The Sample Size for the Training Set

Not applicable. This submission is for software updates to an MRI scanner. It does not describe an AI/ML algorithm that requires a "training set" of data for learning diagnostic patterns. The software functionalities are based on physics principles, signal processing, and numerical algorithms.

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

Not applicable. As there is no "training set" in the context of an AI/ML algorithm, the concept of establishing ground truth for it does not apply to this submission.

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 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).

Ask a specific question about this device

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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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/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System. The Vantage Titan 3T uses 1.6m short and 6.4 tons light weight magnet. It includes the Toshiba Pianissimo™ technology (scan noise reduction technology). The design of the gradient coil and the WB coil of the Vantage Titan 3T provides the maximum field of view of 50 x 50 x 45 cm.

The Vantage Titan 3T MRI System is comparable to the current 1.5T EXCELART Vantage Titan MRI System (K080038), cleared January 22, 2008 with the following modifications.

• . Field strength of magnet has been changed to 3T.
• . RF amplifier, transmitter and receiver (RF cabinet) are modified to adopt the change in resonance frequency (63MHz -> 123MHz).
• . Number of RF amplifier channels is increased from 1 to 2.
• Number of receiver channels is 16ch for standard (same as Titan 1.5T), 32ch for optional. .
• Software platform has been changed. .

Below is an analysis of the provided text regarding the Toshiba America Medical Systems, Inc. AUG – 2 2011 Pre-Market Notification 510(k) MRT-3010/A5 Vantage Titan 3T.

Device Name: Vantage Titan 3T (Model MRT-3010/A5) is a 3 Tesla Magnetic Resonance Imaging (MRI) System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparison study for regulatory clearance (510(k) submission) to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy metrics. The "acceptance criteria" here are based on safety parameters outlined by recognized consensus standards and a qualitative assessment of imaging performance.

The study primarily focuses on demonstrating that the new 3T system, despite changes in field strength and associated hardware/software, maintains the safety profile and "imaging performance" (qualitatively, meaning it produces diagnostically usable images) comparable to its predicate 1.5T device, while adhering to relevant international standards for medical electrical equipment.

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

The document states: "Additionally, volunteer studies were conducted to verify imaging performance."

• Sample Size: Not specified. It only mentions "volunteer studies" (plural), suggesting more than one, but no specific number of volunteers is provided.
• Data Provenance: Not explicitly stated, but given Toshiba Corporation is in Japan and the submission is to the US FDA, the volunteer studies could have been conducted in Japan, the US, or elsewhere. It is a prospective collection for the purpose of verifying imaging performance with the new device.

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

• The document does not specify the number of experts used for reviewing the images from the volunteer studies.
• It does mention the intended output: "When interpreted by a trained physician, these images yield information that can be useful in diagnosis." This implies that expert interpretation is expected for clinical use, but not for the "verification" process itself.
• No qualifications for "experts" (if any were involved in verifying performance) are provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the test set (volunteer studies). The purpose of these studies was "to verify imaging performance," which likely refers to image quality and diagnostic utility, rather than specific diagnostic accuracy for a particular condition.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
• This device is an MRI system itself, not an AI-powered diagnostic tool, so such a study would not be relevant to its regulatory clearance in this context. The comparison is between the new 3T MRI device and a previous 1.5T MRI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone (algorithm only) performance study was not done.
• Similar to point 5, this device is a medical imaging system, not an AI algorithm. Its performance is evaluated on its ability to produce high-quality diagnostic images.

7. Type of Ground Truth Used for the Test Set

For the "volunteer studies," the "ground truth" was likely based on:

• Qualitative assessment of image quality: Experts would likely assess image clarity, resolution, contrast, artifact levels, and overall diagnostic interpretability against established standards for MRI.
• Physiological normalcy/absence of pathology in healthy volunteers: If healthy volunteers were used, the "ground truth" would be the expected normal anatomy and physiology, against which the MRI images would be evaluated for accuracy of representation.
• It is not pathology, outcomes data, or expert consensus on specific disease diagnosis from the text provided, as it was for "verifying imaging performance" in volunteers.

8. Sample Size for the Training Set

• Not Applicable. The Vantage Titan 3T is a hardware imaging system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI models.
• The software changes mentioned (new RF amplifier control, gradient power supply control, magnet supervisory control, modified SAR/distortion databases, new software platform) refer to engineering and control software, not AI training data.

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

• Not Applicable. As explained in point 8, there is no "training set" for an AI algorithm in this context. The "ground truth" for the device's operational software would be derived from engineering specifications, physics principles, and established safety standards.

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