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The intended use of the JET software is to get high-resolution anatomical images with minimal artifacts due to physiologic motion which can interfere with image quality. This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions.

Imaging of:

Any anatomies that can have the artifact caused by the physiologic motion such as:.

• CSF flow .
• Abdominal or chest wall movement due to the breathing .
• Respiratory movement on shoulders .
• Uncontrolled movements due to the stroke, pediatric or uncooperative patients ●

JET software provides high-resolution anatomical images with minimal artifacts due to physiological motion, which is caused by movement of anatomical regions due to breathing, CSF flow or other involuntary movements and can interfere with image quality.

The provided text is a 510(k) Premarket Notification for the Toshiba America Medical Systems, Inc. JET Software. The document focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a detailed study proving performance against acceptance criteria, or most of the other requested details regarding the study design and ground truth establishment.

Here's a breakdown of the information that can be extracted and the information that is missing:

The submission is primarily focused on demonstrating substantial equivalence to a previously cleared device (K063361), implying that the performance is expected to be similar or better without a need for a new comprehensive performance study against specific acceptance criteria. The approval indicates the FDA found the device substantially equivalent based on the information provided, which likely includes technical comparisons rather than a full clinical performance study with defined acceptance criteria and statistical analysis against those criteria.

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

• Acceptance Criteria (Extrapolated from Intended Use/Device Description):

  • Produce high-resolution anatomical images.
  • Minimize artifacts due to physiological motion (e.g., CSF flow, breathing, uncontrolled movements).
  • Improve signal-to-noise ratio by eliminating or reducing image degradation caused by motions.

• Reported Device Performance: The document states that the "Algorithm was modified to support a new combination of image acquisition and reconstruction techniques." It also claims that the software is expected to "get high-resolution anatomical images with minimal artifacts due to physiologic motion... This technique can also provide the improvements on signal-to-noise with eliminating or reducing the image degradation caused by the motions."

  • Direct performance metrics against explicit acceptance criteria are NOT provided in the submission. The submission is a justification of substantial equivalence, not a detailed performance study with quantitative results.

Missing Information (Not Available in the Provided Text):

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

• Not specified. The document does not describe a "test set" in the context of a performance study.

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/Not specified. Ground truth establishment for a test set is not discussed.

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

• Not applicable/Not specified.

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 specified. The document focuses on the software's image quality improvement, not on its impact on human reader performance in a comparative effectiveness study.

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

• Not explicitly described as a standalone study with quantitative metrics. The device itself is software (an algorithm), and its intended function is to improve image quality. The claim of "high-resolution anatomical images with minimal artifacts" and "improvements on signal-to-noise" implies a standalone performance, but no specific study design or results are provided.

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

• Not specified. Given the nature of the device (image quality improvement for motion artifacts), ground truth would likely involve expert visual assessment of artifact reduction and image clarity, but this is not detailed.

8. The sample size for the training set

• Not specified. The document does not mention a "training set" for the algorithm, as it predates the common terminology for deep learning models. It discusses algorithm modifications and new acquisition/reconstruction techniques.

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

• Not applicable/Not specified. No training set is mentioned in the context of ground truth.

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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 Cholanqiopancreatography), 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™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.

• New gantry design as Ultra-short bore. .
• . New patient couch design as wide couch top.
• It is possible to combine detachable couch top and gurney of exclusive use. .
• . The CPU of computer system was changed from RISC type to Xeon.
• . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
• . SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
• The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
• The gating waveform can be displayed by the side of the gantry. .

This document describes a 510(k) submission for the EXCELART Vantage™ XGV/AGV MRI system. The submission focuses on demonstrating substantial equivalence to a predicate device, the EXCELART™ with Pianissimo XG/AG SPIN Edition.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on comparing the safety and imaging performance parameters of the new device to its predicate. The acceptance criteria essentially align with maintaining or improving upon the predicate device's specifications, particularly within regulated safety limits.

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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.

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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

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.

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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.

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