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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 software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper), MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper)

Here's an analysis of the provided 510(k) summary relating to acceptance criteria and the study conducted:

Disclaimer: The provided document (K983110) is a 510(k) Premarket Notification summary from 1998 for a software upgrade to existing Magnetic Resonance Diagnostic Devices (FLEXART™ and VISART™). It focuses on demonstrating substantial equivalence to previously cleared devices. It primarily discusses safety parameters and imaging performance specifications rather than a typical clinical study with acceptance criteria for a new AI/CAD device.

This document predates widespread AI in medical imaging and the standard AI/CAD study structure. Therefore, many of the requested fields (like sample size for test/training sets, ground truth establishment methods, MRMC studies, effect sizes, and standalone performance) are not directly addressed in the provided text as they pertain to a different type of device evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document, the "acceptance criteria" are more akin to specifications that the software upgrade maintains, and the "reported device performance" indicates that these specifications are met or comparable to the predicate devices.

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Imaging of:

• The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, -The whole body (including reast). [Application terms include MR Fluoroscopy, MR Irography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
• Fluid Visualization -
• 2D/3D Imaging -
• MR Angiography/MR Vascular Imaging -

This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.

The provided text describes a 510(k) summary for a Magnetic Resonance Device (MRT-150/H1, MRT-150/F1, MRT-150/H2, MRT-150/F2, marketed as VISART and VISART/Hyper). It introduces upgrades to the software (from V3.1 to V3.5) and hardware (VISART/Hyper system with increased gradient field strength and optional phased array coils).

Here's an analysis based on the information provided, specifically addressing the questions you've posed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes safety and imaging performance parameters for the device. While explicit "acceptance criteria" for a study aren't clearly defined as pass/fail thresholds in the typical sense for a clinical study, the specifications listed for the upgraded devices represent the targeted performance that was demonstrated to be met.

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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 VISART™ consists of two model upgrades to the MRT-150A system which provide increased gradient field strength, more ergonomic computer architecture, improved scan parameter specifications and a lighter magnet than the MRT-150A.

This is a pre-amendment 510(k) submission for the VISART™ Magnetic Resonance Device, MRT-150A/H1 and MRT-150A/F1 models. The submission primarily focuses on demonstrating substantial equivalence to an existing device (MRT-150A) by highlighting hardware and software upgrades that improve performance without introducing new safety or effectiveness questions. The provided text, however, does not contain details about a specific study testing device performance against defined acceptance criteria in the manner typically seen for algorithmic or AI-based devices.

The submission describes general increases in imaging performance parameters and safety parameters compared to the predicate device. It also mentions that "Sample phantom images and clinical images were presented for all new sequences demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing." This indicates that some form of evaluation was performed, but the specifics of a structured study with statistical outcomes are not detailed.

Given the information provided, I cannot fully answer your request in the format you've outlined for an AI/algorithm-driven device's acceptance criteria and study. However, I can extract the relevant information as much as possible based on the provided text.

Here's an attempt to address your request based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the upgraded models in a quantitative, pass/fail manner. Instead, it highlights improvements over the predicate device (MRT-150A) and states conformance with "consensus standards requirements."

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