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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging. ]
• . Fluid Visualization
• . 2D / 3D Imaging
• MR Angiography / MR Vascular Imaging .
• Blood Oxygenation Level Dependent (BOLD) imaging .
• Perfusion / Diffusion Imaging .
• Proton Spectroscopy .

The EXCELART Vantage Atlas is a 1.5 tesla Magnetic Resonance Imaging (MRI) System. The Atlas has a 1.4 m short magnet (55 cm field of view) and includes Toshiba's Pianissimo™ technology (scan noise reduction technology). The wide bore has a 655 mm opening.

There are two models in the EXCELART Vantage Atlas line as follows:

• EXCELART Vantage Atlas-Z Model No. MRT-1503/S3
• EXCELART Vantage Atlas-X Model No. MRT-1503/S3

The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications:

• . 16 Channel phased array system control
• . CPU performance of the computer system has been enhanced
• The longitudinal movement of the patient couch has been increased
• . Additional table top coil ports
• . Additional RF coils – Atlas SPEEDER Head, Atlas SPEEDER Spine, and Atlas SPEEDER Body)
• SAR limit is 4 W/kg for whole body in conformance with IEC 60601-2-33 (2002)

The provided 510(k) summary for the EXCELART Vantage Atlas MRI system (K063361) indicates that this device is a modification of a previously cleared device, the EXCELART Vantage ZGV MRI System (K060003). Therefore, the submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo study with specific acceptance criteria and detailed performance metrics comparing it to a ground truth.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not contain explicit acceptance criteria in the form of quantitative performance targets (e.g., sensitivity, specificity, accuracy, or image quality metrics) against a specific ground truth. Instead, the acceptance is based on demonstrating that the modified device maintains the safety and imaging performance of its predicate device, subject to specific hardware and software changes.

The "performance" is implicitly demonstrated through the declaration that "No changes from the previous submission, K060003" for both "IMAGING PERFORMANCE PARAMETERS" and "INTENDED USE." This means the device is expected to perform at least comparably to the predicate device, which would have had its own performance established during its clearance.

Therefore, a table cannot be directly constructed for acceptance criteria and reported device performance for this specific 510(k) in the way one might for a software algorithm with diagnostic outputs.

The primary change that might be considered an "acceptance criterion" related to safety is:

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

The document does not describe a specific test set in terms of patient data or images used to evaluate the new device's imaging performance. The substantial equivalence argument relies on the inherent design and engineering principles, stating "No changes from the previous submission, K060003" for imaging performance. This implies that if any testing was done beyond engineering verification, it would have been at the component or system level, not necessarily on a distinct patient image dataset with a ground truth.

Given the nature of the submission (hardware/software modifications to an existing MRI system), rigorous clinical image-based testing on a test set with human readers is not explicitly detailed. The provenance of such data, if it existed, is not mentioned.

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

As no specific clinical test set for performance evaluation is described, there is no mention of experts establishing ground truth for such a set within this document.

4. Adjudication method for the test set

Since no specific clinical test set for performance evaluation is described, no adjudication method is mentioned.

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 MRMC comparative effectiveness study was done or reported in this 510(k) submission. This is consistent with the device being a hardware/software update to an MRI system itself, rather than an AI-driven image analysis tool.

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

No standalone algorithm performance study was done or reported. The device is an MRI system, not an independent algorithm.

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

Given the nature of the submission (modifications to an existing MRI machine), the concept of "ground truth" in the diagnostic performance sense is not applicable to this document's scope. The "truth" being established is that the modified system retains the safety and imaging capabilities of the predicate device, which would likely have been verified through engineering tests, phantom studies, and potentially limited clinical scans, rather than large-scale diagnostic accuracy studies.

8. The sample size for the training set

No training set is mentioned or applicable for this device. This is a hardware/software update to a medical imaging device, not a machine learning or AI algorithm that requires a training set.

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

As there is no training set, this question is not applicable.

In summary, this 510(k) submission is for modifications to a previously cleared MRI system. The "acceptance criteria" and "proof" of meeting them primarily revolve around demonstrating that the changes (increased channel count, CPU enhancement, new coils, increased SAR limit) do not negatively impact the established safety and performance of the predicate device, or that any changes remain within acceptable regulatory limits (e.g., increased SAR is still compliant with IEC standards). There is no indication of a new clinical performance study with a test set, experts, or ground truth establishment as would be typical for a novel diagnostic device or AI algorithm.

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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.]
• Fluid Visualization.
• 2D / 3D Imaging
• MR Angiography / MR Vascular Imaging.
• Blood Oxygenation Level Dependent (BOLD) imaging
• Perfusion / Diffusion Imaging.
• Proton Spectroscopy.

The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.

• The maximum gradient strength and the maximum slew rate have been increased.
• The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz.
• SAR 1st level operating mode as specified in IEC 60601-2-33 (2002).
• The performance (Min.TR/Min.TE / Min.Slice thickness) of a sequence has been improved.

The provided text describes specific features and safety parameters of a Magnetic Resonance Diagnostic Device Accessory (MRT-1503/P5, EXCELART Vantage™ ZGV) and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving those criteria were met, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.

The document is a 510(k) summary for a submission to the FDA, primarily focused on demonstrating "substantial equivalence" to a previously cleared device (EXCELART Vantage™ XGV/AGV, K032490). The changes highlighted are hardware and software modifications that improve performance or allow for access to specific operating modes, but these are not presented as acceptance criteria against specific performance metrics (e.g., sensitivity, specificity for a diagnostic task).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria or a study proving their fulfillment from the provided text.

The document states:

• "IMAGING PERFORMANCE PARAMETERS: No changes from the previous submission, K032490." This implies that the imaging performance is expected to be the same as the predicate device, but it doesn't detail what those performance parameters are or how they were assessed.
• "TOSHIBA Medical Systems Corporation believes that the new EXCELART Vantage™ ZGV (model MRT-1503/P5) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELART Vantage™ XGV/AGV (model MRT-1503/P3, MRT-1503/P2) (K032490 ) cleared on August 21, 2003." This is the core argument for clearance, not a report of a specific study proving the new device's performance against defined acceptance criteria.

The FDA's letter confirms the substantial equivalence determination based on the indications for use.

To answer your request, a different type of document, such as a clinical validation report or a detailed performance specification document, would be needed.

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Imaging of:

• . The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 }
• Fluid Visualization { K002531 } ●
• . 2D / 3D Imaging { K002531}
• . MR Angiography / MR Vascular Imaging {K002531}
• Blood Oxygenation Level Dependent (BOLD) imaging { K002531} ●
• Perfusion / Diffusion Imaging {K993803, K002531}
• . Proton Spectroscopy { K010129}

The EXCELART™ with Pianissimo XG/AG SPIN Edition system has the following features compared to the current EXCELART™ with Pianissimo XG/AG system.

• Extension of a receiving system is enabled a maximum of 8 ch. .
• Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
• The computer only for reconstruction was carried for high-speed image processing. .
• . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
• Max. field strength is changed 25mT/m to 30mT/m. .
• . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
• The user interface of software was changed for the improvement of operativity. '
• . Gating unit was redesigned to improve the making triggers for sequence.

The provided text is a 510(k) summary of safety and effectiveness for a Magnetic Resonance Diagnostic Device Accessory. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document does not contain an independent study with acceptance criteria and a detailed analysis of device performance against those criteria in the way a clinical trial or performance study would typically be structured for a new device claiming improved diagnostic accuracy.

Instead, the submission aims to demonstrate substantial equivalence by showing that the new device (EXCELART™ with Pianissimo XG/AG SPIN Edition) has comparable safety and imaging performance parameters to its predicate device (current EXCELART™ with Pianissimo XG/AG, cleared under K002531), while highlighting specific hardware and software changes.

Therefore, the requested information elements related to acceptance criteria, a specific study proving it, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in this type of submission.

However, I can extract and present the available information in a structure that addresses your points where possible, along with explaining why other points cannot be answered from this document.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission does not present a standalone study with defined acceptance criteria for diagnostic performance of the device against a gold standard in the typical sense of a clinical trial for a new diagnostic claim.

Instead, the device seeks substantial equivalence to a predicate device (EXCELART™ with Pianissimo XG/AG, K002531). The "acceptance criteria" can be inferred as maintaining similar or improved safety and imaging performance characteristics as the predicate device, especially regarding the new features. The study, implicitly, is the comparison of technical specifications and performance against the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with specific thresholds for performance metrics (like sensitivity, specificity, accuracy) are not provided in a 510(k) summary focused on substantial equivalence based on technical changes, I will present the key safety parameters where changes or comparisons were made. The "reported device performance" in this context refers to the parameters of the new device relative to the predicate.

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

• Sample Size: Not specified. This 510(k) summary focuses on technical specifications and comparisons rather than a clinical study with a patient test set for diagnostic performance. The "testing" appears to be largely engineering and phantom-based to verify new functionalities and safety parameters.
• Data Provenance: Not explicitly stated. Given it's a comparison to an existing device, and the manufacturing site is Japan, some internal testing or data may originate from there. However, it's not a dataset of patient images from a specific country.
• Retrospective/Prospective: Not applicable in the context of a clinical performance study with patient data.

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

• Not applicable / Not specified. This document does not describe a clinical study where experts established ground truth for a diagnostic test set. The evaluation is primarily technical and comparative against a predicate device's specifications.

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

• Not applicable. No clinical test set requiring expert adjudication for ground truth is described.

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

• Not applicable. This device is an MRI system and its accessory, not an AI-powered diagnostic algorithm or an assistance tool for human readers. Therefore, an MRMC study related to human-AI collaboration is not relevant or described.

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

• Not applicable. This is an MRI hardware and software update, not a standalone diagnostic algorithm.

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

• Implicitly, engineering specifications and measurements. For parameters like static field strength, acoustic noise, SAR, and dB/dt, the "ground truth" is derived from physical measurements and adherence to regulatory standards (e.g., IEC 60601-2-33). For "imaging performance," the claim is "no changes from the previous submission, K002531," implying that the imaging quality is at least equivalent to the already cleared predicate device, which would have undergone its own validation based on established imaging metrics.

8. The sample size for the training set

• Not applicable / Not specified. This is not an AI/ML device that requires a training set in that context. The "training" for the system would involve engineering development and quality control, not data-driven model training.

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

• Not applicable. As above, there is no "training set" in the context of machine learning for this device.

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Imaging of: The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.] Fluid Visualization 2D/3D Imaging MR Angiography/MR Vascular Imaging Blood Oxygenation Level Dependent (BOLD) Imaging Diffusion Imaging The EPI Plus optional package adds the following to the above indications: Perfusion Imaging

This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared EXCELARTTM (K990620) with the following new functions added to the standard system. • Pianissimo: Gradient acoustic reduction system • QD Whole Body coil • QD Head coil • QD C/T/L Spine Array coil • 18.1" LCD flat screen monitor • Increase of SAR limit from <1.0 Watts/Kg to < 1.5 Watts/Kg The following optional features are introduced in this submission. • Flexible Body Array coil • Shoulder Array coil • Storage Plus Package which includes: * 8 GByte hard disk drive * memory increase of 256 MBytes • EPI Plus Package (see Appendix 15) which includes: * extending Diffusion function * adding Perfusion function • Super FASE Plus Package (see Appendix 19) which includes: * ECG - Preparation * Fresh Blood Imaging (FBI) * Swap Phase Encode Extended Data acquisition (SPEED) * Composite MIP · MRA Plus Package (see Appendix 23) which includes: * Visual Preparation * Moving Bed * 3D Centric scan * Sequential Target MIP Display (STAMD)

This document is a 510(k) Premarket Notification for a Magnetic Resonance Diagnostic Device Accessory (MRI system), specifically the EXCELART™ with Pianissimo. The submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel AI algorithm or diagnostic tool.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or not explicitly detailed in this type of submission for this kind of device. The focus here is on the safety and performance characteristics of the MRI system itself and its accessories.

Here's a breakdown based on the provided text, indicating what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

For an MRI system, performance is generally evaluated against safety parameters and imaging capabilities rather than diagnostic accuracy metrics. The document specifies safety parameters and imaging volumes.

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 study on a diagnostic algorithm's performance on a dataset of patient images. The "test set" for an MRI system's technical specifications typically involves phantom measurements and engineering tests. The acoustic noise data was measured in accordance with NEMA guidelines, indicating a standardized testing methodology.

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 applicable. This filing is about the technical specifications and safety of an MRI device and its accessories, not a diagnostic algorithm requiring ground truth established by medical experts on patient data.

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

Not applicable. See point 3.

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

Not applicable. This device is an MRI system, not an AI diagnostic tool.

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

Not applicable. This is an MRI hardware and associated software update, not a standalone diagnostic algorithm.

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

Not applicable. The "ground truth" for this device would be its physical and electronic measurements (e.g., magnetic field strength, RF power, acoustic noise levels, imaging volume specifications) which are verified through engineering tests and NEMA standards, not clinical "ground truth" on patient diagnoses.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic interpretation that would involve a training set of images.

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

Not applicable. See point 8.

In summary of the study that proves the device meets the acceptance criteria:

The study proving the device meets its acceptance criteria is implicitly the engineering and performance testing conducted by the manufacturer (Toshiba Corporation) for the MRI system and its components. This includes:

• Physical measurements for safety parameters like static field strength, rate of change of magnetic field, and radio frequency power (SAR).
• Acoustic noise measurements conducted in accordance with NEMA guidelines (National Electrical Manufacturers Association), which are standard procedures for evaluating MRI system noise. The reported 86.0 dB for the Pianissimo system versus 110.8 dB for the standard EXCELART™ demonstrates an improvement in acoustic performance.
• Verification of imaging performance parameters such as head and body specification volumes (16cm dsv and 28cm dsv, respectively), which are stated to be the same as previously cleared systems, implying continued adherence to established performance benchmarks.
• Demonstration of "substantial equivalence" for new coils and software packages to previously cleared devices (e.g., K990620 for EXCELART™, K922798, K965068, K961092, K942609 for various coils, and K983110 for software V4). This is the primary method of "proof" for a 510(k) submission: showing the new device is as safe and effective as a legally marketed predicate device.

The document does not detail specific study protocols, raw data, or results from these tests beyond the summary values provided in the table. The FDA's clearance (K993803) indicates that these submissions were deemed sufficient to demonstrate substantial equivalence for marketing.

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Imaging of:

• The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
• . Fluid Visualization
• 2D/3D Imaging
• MR Angiography/MR Vascular Imaging
• Blood Oxygenation Level Dependent (BOLD) Imaging .

This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K983110). All other technology used for the EXCELART system is the same as that of the cleared VISART™/Hyper system.

The provided text is a 510(k) Premarket Notification for the EXCELART Magnetic Resonance Diagnostic Device Accessory (MRI System). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent clinical study results with detailed acceptance criteria and performance metrics for a new, non-inferiority claim.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudications are not explicitly stated or applicable in the context of this 510(k) submission.

Here's an analysis of the provided information relative to your request:

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

The submission does not outline specific, quantitative acceptance criteria for image quality or diagnostic accuracy in the way a clinical study for a new AI device would. Instead, it demonstrates that the EXCELART system's safety and imaging performance parameters are comparable to its predicate device, the VISART™/Hyper system.

Study to prove device meets acceptance criteria:

The "study" presented is less a formal clinical trial and more a comparison of technical specifications and design similarities to a previously cleared device. The core argument for meeting acceptance criteria (i.e., being safe and effective) is substantial equivalence to the VISART™/Hyper MRI system (K965068). The modifications (short bore magnet and gantry design) are stated to "not raise new questions of safety or efficacy."

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

• Sample Size: Not applicable/not provided. This is a technical comparison for substantial equivalence, not a clinical study on a test set of patient data.
• Data Provenance: Not applicable. The data primarily consists of engineering specifications and design details of the device itself, compared to a predicate device.

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

• Number of experts & Qualifications: Not applicable. Ground truth as typically defined for clinical performance (e.g., diagnostic accuracy studies) is not established in this document. The "ground truth" for this submission is the established safety and efficacy of the predicate device (VISART™/Hyper) and the technical measurements of the EXCELART system itself.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There is no test set in the sense of patient cases requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• MRMC study: No. This document is a 510(k) submission for substantial equivalence based on technical specifications and design, not an MRMC comparative effectiveness study involving human readers or AI assistance.

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

• Standalone performance: Not applicable. The EXCELART is an MRI system, not an AI algorithm.

7. The type of ground truth used

• Type of ground truth: The "ground truth" for this submission is the established safety and effectiveness of the predicate device (VISART™/Hyper), as determined by previous FDA clearance, and the technical specifications and performance measurements of the EXCELART system demonstrating comparability. The software (V4, K983110) is also previously cleared.

8. The sample size for the training set

• Training set sample size: Not applicable. This is not an AI/machine learning device that would have a training set.

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

• Ground truth for training set: Not applicable. (As above, not an AI/ML device).

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