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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, -The whole body (including reast). [Application terms include MR Fluoroscopy, MR Irography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
• Fluid Visualization -
• 2D/3D Imaging -
• MR Angiography/MR Vascular Imaging -

This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.

The provided text describes a 510(k) summary for a Magnetic Resonance Device (MRT-150/H1, MRT-150/F1, MRT-150/H2, MRT-150/F2, marketed as VISART and VISART/Hyper). It introduces upgrades to the software (from V3.1 to V3.5) and hardware (VISART/Hyper system with increased gradient field strength and optional phased array coils).

Here's an analysis based on the information provided, specifically addressing the questions you've posed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes safety and imaging performance parameters for the device. While explicit "acceptance criteria" for a study aren't clearly defined as pass/fail thresholds in the typical sense for a clinical study, the specifications listed for the upgraded devices represent the targeted performance that was demonstrated to be met.

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

The document mentions "Sample phantom images and clinical images were presented for all new sequences".

• Sample Size for Test Set: This is not explicitly stated in terms of the number of clinical images or patients.
• Data Provenance: This is not explicitly stated. It's likely from Japan (where the manufacturing site is located) but not confirmed. The document does not specify if it was retrospective or prospective.

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

This information is not provided in the document. The submission focuses on technical specifications and device equivalency rather than a clinical study requiring expert ground truth for interpretation.

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

This information is not provided. As no clinical study requiring expert interpretation is described in detail, adjudication methods would not typically be 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 reported. This submission predates the widespread integration of AI in medical imaging interpretation as described in the 510(k) summary (1996). The improvements mentioned are related to image quality provided by the updated device hardware and software, not AI assistance for human readers.

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

Not applicable/Not reported. This device is an MRI machine with upgraded software and hardware, not a standalone algorithm.

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

For the safety and performance parameters, the "ground truth" seems to be objective measurements against design specifications and consensus standards. For example:

• Safety parameters (field strength, RF power, acoustic noise): Measured values against established safety limits and NEMA guidelines.
• Imaging performance parameters (SNR, Uniformity, Slice Profiles, Geometric Distortion, Slice Thickness/Interslice Spacing): Demonstrated conformance with "consensus standards requirements" using phantom and clinical images.
  No specific ground truth (expert consensus, pathology, outcomes data) for diagnostic accuracy is described since this filing is about device upgrades and equivalency, not a diagnostic accuracy claim for a specific clinical indication based on interpreted images.

8. The sample size for the training set:

Not applicable/Not reported. This document describes an MRI device upgrade, not a machine learning algorithm that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:
Not applicable/Not reported. As above, this is an MRI device, not an AI algorithm requiring a training set.

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