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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, 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 MR Angiography/MR Vascular Imaging

The Large and Medium Flexible QD Body coils are essentially a QD (quadrature) extension and a flexible version of the standard Body Coil. The extension consists of adding a saddle trace to the existing solenoid trace. The two independent RF traces have RF magnetic fields which are orthogonal (oriented at 90 degrees with respect to each other) to create a quadrature coil. The NMR signals from the two independent loops are sent to an RF front end where they are then amplified and combined (summed) to provide a resultant signal with improved signal-to-noise ratio. With the coil's flexibility. RF connectors are added which enable the coil to open for patient loading. This enables the coil to be placed directly on the patient pallet. The standard body coil requires the patient to lay on the patient pallet then the patient with pallet is slid through the body coil. An advantage of placing the patient directly on the coil is that the pallet does not go through the coil. Hence the pallet is not filling the coil. This enables the coil to be physically smaller, for improved signal to noise, without losing space for patient loading.

The provided document is a 510(k) Premarket Notification for a Magnetic Resonance Diagnostic Device Accessory (OPART™ MRT-600 Large and Medium Flexible QD Body coils).

This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device, not necessarily on proving that the device meets specific performance acceptance criteria through a rigorous independent study with defined metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or how ground truths were established, as these are typically part of a comprehensive clinical study report, which is not included here.

Instead, the submission demonstrates "safety and effectiveness" by comparing the new device to a predicate device (Matrix 3000 Flexible Spine Coil, K964753) and stating that the modifications "do not raise new questions of safety or efficacy."

However, I can extract the safety and imaging performance parameters listed for the device, which might be considered "acceptance criteria" in a general sense for the device's operational characteristics, rather than diagnostic accuracy.

Here's a summary of what information is available in the provided text, structured to address your request as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, these are not diagnostic performance metrics, but rather operational specifications. The document implicitly states that the device meets these specifications as part of its design and intended function, making it substantially equivalent to the predicate.

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

• Sample Size for Test Set: Not applicable/not provided. The document mentions "Sample phantom images and clinical images are presented from both the Large Flexible QD Body coil (Appendix D & E) and the Medium Flexible QD Body coil (Add to file appendix 2 and 3)." This suggests internal testing for functionality and image quality, but not a formal clinical test set with statistical power calculations typically associated with diagnostic performance studies. The number of images or cases is not specified.
• Data Provenance: Not specified. Given the context of a 510(k) for a device accessory, it's likely internal testing data.

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

• Not applicable/not provided. This information is relevant for studies evaluating diagnostic accuracy, which is not the primary focus of this 510(k) submission for a coil accessory.

4. Adjudication method for the test set

• Not applicable/not provided.

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 is a device accessory (MRI coil), not an AI diagnostic algorithm.

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

• Not applicable. This is a device accessory (MRI coil), not an AI diagnostic algorithm.

7. The type of ground truth used

• For the operational parameters (safety and imaging performance), the "ground truth" would be established through physical measurements, engineering tests, and adherence to established MRI system standards for signal detection within specified volumes. For image quality, it would likely be qualitative assessment against expected standards, as implied by the submission of "sample phantom images and clinical images." There is no mention of pathology, outcomes data, or expert consensus in a diagnostic sense.

8. The sample size for the training set

• Not applicable/not provided. This is a hardware accessory, not a machine learning model requiring a training set.

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

• Not applicable/not provided.

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