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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 ●
• MR Angiography / MR Vascular Imaging .
• . Water / Fat Imaging
• Perfusion / Diffusion Imaging .

The OPART™ /Ultra system is added into existing OAPRT™ series by incorporating the high performance gradient system. The OPART™ /Ultra system and the OPART™ system with Ultra gradient upgrade kit offers the modified sequences for the faster acquisition than existing OPART™ systems.

The provided text describes a 510(k) submission for a Magnetic Resonance Diagnostic Device Accessory, the OPART™/Ultra, and its upgrade kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not present in the provided text.

However, I can extract and present the information that is available.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present "acceptance criteria" in a quantitative format for imaging performance. Instead, it compares safety parameters of the new device (OPART™/Ultra) against its predicate (OPART™) and other substantially equivalent devices. The "performance" here refers to physical and operational characteristics rather than diagnostic accuracy.

A note on "acceptance criteria": For a 510(k) submission like this, the "acceptance criteria" for safety parameters are often implicitly that the new device's performance remains within acceptable safety limits, or that any changes do not adversely affect safety and are appropriately documented. The increases in acoustic noise (115.4 dB Peak, 102.5 dB A-weighted) and maximum dB/dt (51 T/sec) for the OPART™/Ultra are noted, and the document states that TOSHIBA performed "dB/dt and acoustic noise verifications," implying these increases were evaluated for safety and deemed acceptable for the intended use. The core "acceptance criterion" for the overall device is substantial equivalence to legally marketed predicate devices.

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

The document does not describe a "test set" in the context of diagnostic performance evaluation with patient data. The evaluations mentioned are primarily engineering-based verifications of physical parameters and comparisons to predicate device specifications. There is no mention of patient data being used for device performance testing in this document.

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

Not applicable. As no diagnostic performance study utilizing patient data and ground truth is described, there's no mention of experts or their qualifications.

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

Not applicable, as no diagnostic performance study 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 is a submission for an MRI system and its upgrade, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This document is about a hardware and software upgrade for an MRI system, not a standalone algorithm.

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

Not applicable, as no diagnostic performance study requiring ground truth is described. The "ground truth" for the engineering parameters would be the actual measured values of the physical characteristics (e.g., static field strength, acoustic noise, SAR, dB/dt).

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm that requires a training set. The software changes are related to system control, improved user interface, and new or modified acquisition sequences.

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

Not applicable, as no training set for a machine learning algorithm is discussed.

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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, small parts which include: wrist, elbow, ankle, shoulder, hand, knee). [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 Flexible Small Parts coil is comprised of a flexible coil winding, tune box, and clamp. The flexible coil winding is fabricated from a single strip of copper and encased in soft closed cell foam. The winding conforms to the irregular surface of anatomy and keeps the shape it is formed to while the foam provides consistent spacing between the windings and anatomy.

Decoupling is dual active and achieved with PIN diodes. The impedance of the coil is 50 ohms nominal and it is a solenoid type coil.

The Flexible Small Parts coil is constructed with the same materials that are currently in use for the released coil set for OPART™.

This request cannot be fulfilled. The document does not contain information about acceptance criteria and device performance for the K991740 submission. It describes a medical device accessory (Flexible Small Parts coil for OPART™ MRI system) and states its intended use, but it does not include performance metrics or a study. The document is primarily a 510(k) summary and the FDA's clearance letter, which focus on substantial equivalence to a predicate device rather than detailed performance studies against specific acceptance criteria.

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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 neok, Ywis, Hoard Broomy), 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 .

Version 2.5/V2.6 software is a combination of modifications and the enhancement of sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. This software will function on both SGI Indigo 2 and O2 computer workstations. The V2.6 software may also be identified as Performance Plus option.

The provided document is a 510(k) Premarket Notification for a diagnostic magnetic resonance device (OPART™ version 2.5/2.6 software for MRT-600) from 1999. It focuses on the safety and imaging performance parameters of the MR system and its software updates. It does not contain information related to a clinical study with acceptance criteria for a device's diagnostic performance, nor does it describe a study involving human readers, ground truth establishment, or multi-reader multi-case analysis as typically seen for AI/CAD devices.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance

The document lists "Safety Parameters" and "Imaging Performance Parameters" which function as specifications for the device. These are accepted as meeting the requirements for substantial equivalence.

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. The document mentions "sample phantom images and clinical images" were presented, but no details on the sample size, provenance, or study design are given.

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)

This information is not provided in the document. The evaluation of imaging performance relies on "consensus standards requirements," implying expert review or established metrics, but specifics on the number or qualifications of experts are absent.

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

This information is not provided in the document.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described. This document pertains to the software update of an MR imaging system itself, not an AI or CAD system designed to assist human readers in interpretation.

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

This document describes the performance of the MR imaging system and its software, which acquires and reconstructs images. Its performance is inherently "standalone" in terms of image generation, but it's not an algorithm that performs diagnostic interpretation without a human-in-the-loop. It confirms the physical and imaging quality of the system, not a diagnostic algorithm.

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

For the "Imaging Performance Parameters," the "ground truth" or reference standard appears to be consensus standards requirements for objective metrics like Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing. This is based on physical or technical measurements and comparisons, rather than clinical ground truth like pathology or outcome data.

8. The sample size for the training set

This information is not provided in the document. The software update (version 2.5/2.6) enhances sequences and does not imply a "training set" in the context of machine learning, which wasn't prevalent for such regulatory submissions in 1999.

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

This information is not provided in the document and is not applicable in the context of this type of device and submission from 1999.

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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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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), Dynavic Scan and Cine Imaging.] - -Fluid Visualization - ・ 2D/3D Imaging - MR Angiography/MR Vascular Imaging -

Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.

The provided text is a summary of a 510(k) Premarket Notification for a software upgrade (Versions 2 (V2) software) for an existing Magnetic Resonance Diagnostic Device Accessory, the OPART™ (MRT-600). The submission focuses on demonstrating substantial equivalence to the previously cleared OPART™ system (K962933) and does not detail a study or specific acceptance criteria for a new device's performance.

Instead, the document asserts that the modifications and new sequences in V2 software do not "raise new questions of safety or efficacy" and do not introduce "any new indications for use." This type of submission relies on the established safety and efficacy of the predicate device, rather than requiring new performance studies with detailed acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from the provided text because such a study was not performed or described. The submission's core argument is that the changes are minor and do not necessitate new performance data.

However, I can extract information related to the device and its intended use:

Device Information from the document:

• 1. A table of acceptance criteria and the reported device performance:
  • Acceptance Criteria: Not explicitly stated as this is a software upgrade claiming substantial equivalence. The "acceptance criteria" here implicitly refer to maintaining the performance and safety profiles of the predicate device (OPART™ K962933).
  • Reported Device Performance: The document provides "Imaging Performance Parameters" for the system, not specifically for the V2 software upgrade's new features. This suggests these are the general capabilities of the MR system.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not applicable/Not provided. The submission states "Sample phantom images and clinical images are presented for new sequences" but does not detail a formal test set, sample size, or data provenance. This aligns with a substantial equivalence claim for a software upgrade.

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

  • Not applicable/Not provided. Ground truth establishment for a test set is not described.

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

  • Not applicable/Not provided. Adjudication methods for a test set are not 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:

  • No. This device is a software upgrade for an MRI system, not an AI-assisted diagnostic tool.

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

  • Not applicable/Not provided. This is an MRI system software upgrade, not an algorithm being tested for standalone performance. "Sample phantom images and clinical images" were presented, which would be an algorithm-only output, but no formal standalone study is described.

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

  • Not applicable/Not provided. No specific ground truth methodology is detailed for the "sample clinical images."

• 8. The sample size for the training set:

  • Not applicable/Not provided. As this is not an AI/machine learning submission, there is no mention of a training set.

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

  • Not applicable/Not provided. No training set is mentioned.

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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

The OPART™ is a modification of the Flexart™ 0.5T system that employes a 0.35T open architecture vertical field superconducting magnet. The computer architecture. operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.

The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document describes a Magnetic Resonance Device (OPART™) and compares its safety and imaging performance parameters to two other MR systems (Flexart™ and Visart™).

Specifically, the text is a 510(k) summary for a medical device (an MRI system), which is focused on demonstrating substantial equivalence to a predicate device rather than on the performance of a software algorithm that would typically have acceptance criteria and a detailed study.

Therefore, I cannot provide the requested information from the given input.

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