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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.

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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, 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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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.

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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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