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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, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] -Fluid Visualization -2D/3D Imaging Additional indications for v3.1, v3.2, & v3.3 (only) - MR Angiography/MR Vascular Imaging - Additional indication for v3.2 & v3.3 (only) - Water/Fat Imaging - Additional indication for v3.3 {only} Perfusion/Diffusion Imaging -

Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows: - v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed - v3.1: Based on v2.5 (K990260) - v3.2: Based on v2.6 (K990260) - v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging

This 510(k) premarket notification describes an upgrade to an existing Magnetic Resonance Diagnostic Device, the OPART™ (Model MRT-600), to software versions v3.0, v3.1, v3.2, and v3.3, along with optional hardware items. The core of this submission is to demonstrate substantial equivalence to previously cleared versions and to justify new functionalities and increased safety parameters.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on safety parameters and imaging performance. The "acceptance criteria" appear to be specified maximums for safety and a general "specification volume" for imaging. The "reported device performance" is essentially that the device operates within these stated limits and produces sample images.

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

The document explicitly states: "Sample phantom images and clinical images are presented for new sequences (see Appendices K & L)."

• Sample Size: Not explicitly stated as a number of patients or images. The term "sample" suggests a limited number, likely a qualitative representation rather than a statistically powered quantitative study.
• Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Toshiba America MRI, Inc., headquartered in South San Francisco, CA, which might imply U.S. data, but this is not confirmed.
• Retrospective or Prospective: Not explicitly stated. Given the context of a 510(k) for software upgrades, it's possible that both retrospective clinical images (to showcase existing capabilities with new software) and prospective images (to demonstrate new sequences) were used, but the document does not specify.

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

This information is not provided in the document. The submission focuses on technical specifications, safety, and substantial equivalence to predicate devices, not on the diagnostic performance validation by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. As there's no mention of expert review or diagnostic accuracy studies, an adjudication method is not applicable to the reported data.

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 comparative effectiveness study was not performed. This submission is for an upgrade to an MRI device's software and optional hardware, not for an AI-powered diagnostic tool. Therefore, there's no "AI assistance" component or improvement effect size to report.

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

A standalone algorithm performance study was not described. The device is an MRI diagnostic system, which inherently requires human operation and interpretation. The "software functionality" refers to image acquisition and reconstruction, not autonomous diagnostic algorithms.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not describe the establishment of ground truth in the context of diagnostic accuracy. The "ground truth" for this submission appears to be:

• Technical Specifications: Measured values for safety parameters (e.g., SAR, acoustic noise).
• Image Quality: Qualitative assessment based on "sample phantom images and clinical images" (Appendices K & L) to demonstrate that the new sequences produce recognizable and potentially diagnostically useful images, implicitly compared to expected image quality from existing MRI systems.
• Substantial Equivalence: The primary "ground truth" for the entire submission is the demonstration that the modified device is as safe and effective as predicate devices, which implies the predicate devices already met certain performance standards.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The software described (v3.0/v3.1/v3.2/v3.3) facilitates image acquisition and reconstruction, and adds new imaging sequences. It is not an AI/ML algorithm that would require a "training set" in the conventional sense of machine learning.

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

This information is not provided and is not applicable, as there is no "training set" for an AI/ML algorithm mentioned in this submission.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily an analysis demonstrating substantial equivalence to previously cleared predicate devices (K990260, K981475, K983110, K962933, K962138, K946244/A1, K933018/S1).

Specific evidence includes:

• Technical Specifications Compliance: The document lists safety parameters (static field strength, rate of change of magnetic field, SAR, acoustic noise) and states that the device operates within these specified limits. The increase in SAR limit from <0.4 W/kg to <1.5 W/kg is specifically justified in Appendix J, indicating a technical evaluation was performed to ensure safety at this higher limit.
• Qualitative Image Review: "Sample phantom images and clinical images are presented for new sequences (see Appendices K & L)." This implicitly demonstrates that the device, with its new software features, can acquire and reconstruct images that are visually acceptable and consistent with traditional MRI output for diagnostic purposes. This is a qualitative assessment rather than a quantitative diagnostic accuracy study.
• Functional Equivalence: The new software functionalities (e.g., multi-phase/multi-slice for cardiac gating, dual-channel RF coil array, Perfusion/Diffusion imaging) and optional hardware items are described and asserted to be substantially equivalent to capabilities already cleared in other predicate devices.

In essence, the "study" is a compilation of engineering specifications, safety analyses, and qualitative imaging demonstrations, all framed within the context of showing that the upgraded device maintains its safety and effectiveness characteristics, and that new features are comparable to those found in already approved devices. There are no detailed clinical trials or diagnostic performance studies described in this summary to "prove" meeting acceptance criteria in a statistical sense for diagnostic accuracy.

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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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