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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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