Search Results

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.

Ask a specific question about this device

Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy.

Version 3.1 software consists of two model upgrades to the FLEXART™ system. The MRT-50GP/E2 (Flexart™) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat supression. The MRT-50GP/H1 (Flexart™/Hyper) increases the gradient field strength over that of the Flexart™ .

This 510(k) summary describes upgrades to an MRI system (FLEXART™ V3.1), focusing on improvements in hardware and software. It primarily discusses safety parameters and imaging performance in the context of demonstrating substantial equivalence to a previously cleared device. Due to the nature of this submission (upgrades to an existing MRI system for improved image quality and functionality, rather than a novel AI/CAD device), many of the specific questions regarding AI device evaluation (e.g., acceptance criteria for diagnostic performance metrics, human reader studies, ground truth establishment) are not directly applicable or reported in this document.

Here's an analysis based on the provided text, highlighting what is and isn't available:

Analysis of Acceptance Criteria and Device Performance Study (K962138)

This submission (K962138) concerns upgrades to an existing Magnetic Resonance Device (FLEXART™ V3.1). The primary goal of the submission is to demonstrate substantial equivalence to a previously cleared device (K933018, FLEXART™) by showing that the upgrades improve performance without raising new questions of safety or efficacy.

Therefore, the "acceptance criteria" and "device performance" in this context are focused on safety parameters and qualitative imaging performance improvements rather than quantitative diagnostic accuracy metrics typically seen for AI/CAD products.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an upgrade to an existing MRI system, the "acceptance criteria" are implicitly tied to maintaining or improving upon the safety and image quality of the predicate device, and demonstrating conformance with consensus standards.

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

• Test Set Description: The document mentions "Sample phantom images and clinical images were presented for all new sequences."
• Sample Size: Not specified. The number of phantom and clinical images used is not provided.
• Data Provenance: Not specified. The country of origin or whether the data was retrospective or prospective is not mentioned. Given the device is manufactured in Japan, it's plausible the initial data may have originated there, but this is not stated.

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

• Ground Truth Establishment: For imaging performance, the assessment was based on "conformance with consensus standards requirements." This implies evaluation against established MRI image quality metrics rather than expert consensus on a specific diagnostic finding.
• Number/Qualifications of Experts: Not specified. There is no mention of experts involved in establishing a specific "ground truth" for the test set images or their qualifications.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not specified. This type of submission does not typically involve diagnostic adjudication for a test set. The evaluation is against technical standards for image quality.

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

• MRMC Study: No. This device is an MRI scanner system, not an AI/CAD diagnostic aid. Therefore, an MRMC comparative effectiveness study to assess human reader improvement with AI assistance is not relevant and was not performed.

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

• Standalone Performance: No. This device is an MRI scanner; it does not perform automated diagnostic interpretation or analysis as a standalone algorithm. Its "performance" refers to its ability to generate high-quality images.

7. The type of ground truth used

• Ground Truth Type: For imaging performance, the "ground truth" implicitly refers to technical conformance with established consensus standards for MRI image quality (e.g., NEMA guidelines, inherent properties of phantom materials) for metrics like SNR, Uniformity, etc. For safety parameters, the "ground truth" is compliance with regulatory limits and industry standards (e.g., IEC standards for gradient fields, NEMA for acoustic noise).

8. The sample size for the training set

• Training Set Sample Size: Not applicable/Not specified. This document describes a software and hardware upgrade to an MRI scanner, not an AI model requiring a "training set." The software improvements are likely based on engineering design and optimization, not machine learning training data in the modern sense.

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

• Training Set Ground Truth Establishment: Not applicable/Not specified. As there is no mention of a "training set" for an AI model, the method for establishing its ground truth is not relevant to this submission.

Ask a specific question about this device