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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

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.

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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.

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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 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 Extra Large Body coil is an enlarged version of the current OPART™ Large Body Coil. This coil is an optional coil which was developed to allow positioning of larger sized patients in the OPART™ system. The Extra Large Body coil can be used as a standalone coil, or in conjunction with the T-spine surface coil (cleared with OPART™ system K962933). Signal is received in QD mode when used in conjunction with the T-spine surface coil.
The Extra Large Body Coil is constructed with the same materials that are currently in use for the released coil set for OPART™.

This document describes the design and regulatory approval of an "Extra Large Body Coil" for an MRI system, the OPART™. The information provided primarily focuses on establishing the device's substantial equivalence to a previously cleared device, rather than a clinical study evaluating its performance against specific acceptance criteria in a medical context.

Based on the provided text, there is no clinical study that explicitly defines and proves the device meets specific performance acceptance criteria in the way typically expected for a diagnostic AI/medical device. Instead, the submission focuses on substantial equivalence for a physical component (the coil) of an MRI system.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for algorithms or diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not applicable here because this is a hardware accessory submission based on substantial equivalence. The "performance" being evaluated is related to physical and safety parameters of the MRI coil.

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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 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 .

This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K983110). All other technology used for the EXCELART system is the same as that of the cleared VISART™/Hyper system.

The provided text is a 510(k) Premarket Notification for the EXCELART Magnetic Resonance Diagnostic Device Accessory (MRI System). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing independent clinical study results with detailed acceptance criteria and performance metrics for a new, non-inferiority claim.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert adjudications are not explicitly stated or applicable in the context of this 510(k) submission.

Here's an analysis of the provided information relative to your request:

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

The submission does not outline specific, quantitative acceptance criteria for image quality or diagnostic accuracy in the way a clinical study for a new AI device would. Instead, it demonstrates that the EXCELART system's safety and imaging performance parameters are comparable to its predicate device, the VISART™/Hyper system.

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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.

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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.

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