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The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.

The Visualase ENVISION platform consists of a PC-based Linux workstation running the ENVISION software tools in an X-windows environment. The device uses a standard Ethernet connection to retrieve image data files from a compatible MRI scanner host. The images may be retrieved as soon as they have been stored on the MRI host, facilitating near real-time analysis of dynamic MRI data.

The Visualase ENVISION software tools perform three primary functions: 1) Image transport, 2) Image processing, and 3) Data display. The Image transport tools negotiate communication with the MRI scanner host, determine the availability of images, facilitate retrieval of image files, facilitate local storage of image files, and notify Image processing tools of new data. The Image processing tools extract relevant data from available MR images and update data analysis information. The Data display tools provide visualization and facilitate manipulation of the data extracted by the Image processing tools.

Data may be processed to display dynamic changes in voxel intensity as a function of image acquisition. Such analysis is useful in analyzing the uptake and washout of MR contrast agents and can be useful for discrimination of tissue type or state. When data from compatible sequences is available, images may also be processed to extract the complex phase angle of voxels as a function of image acquisition. Using proton-resonance-frequency (PRF) shift analysis and image subtraction, changes in complex phase angle may be related back to relative changes in temperature during the study.

The Visualase ENVISION software is compatible with General Electric Signa model MR scanners and can be configured to operate with either LX or EXCITE format images.

The provided 510(k) summary for the K063505 Visualase ENVISION Software System does not contain detailed acceptance criteria or a dedicated study section proving the device meets specific acceptance criteria.

The document discusses the device's technical performance in terms of computation and artifact handling, and asserts substantial equivalence to a predicate device. However, it does not present a formal study with defined acceptance criteria and reported numerical results in the way that would typically be expected for a detailed performance study.

Based on the provided text, here’s a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the 510(k) summary. The document describes how the device handles data and potential artifacts, but not specific quantifiable performance metrics with defined thresholds that the device was tested against.

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. There is no mention of a specific test set or data used for performance validation.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the 510(k) summary, as there's no mention of a study involving expert-established ground truth.

4. Adjudication Method

This information is not provided in the 510(k) summary, as there's no mention of a study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not discussed or presented in the 510(k) summary. The document focuses on the device's technical capabilities and its similarity to a predicate device, not on how human readers' performance is affected by using the device.

6. Standalone (Algorithm Only) Performance Study

While the document describes the software's functions in detail, an explicit standalone performance study with quantifiable metrics like sensitivity, specificity, accuracy, etc., is not presented. The "Technical Performance" section describes data handling and artifact mitigation, which are aspects of standalone performance, but not a formal study with results against specific criteria.

7. Type of Ground Truth Used

This information is not provided, as there is no mention of a formal study utilizing ground truth.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not discuss any machine learning or AI components that would typically involve a training set.

9. How Ground Truth for the Training Set Was Established

This information is not provided, as there is no mention of a training set or its associated ground truth establishment.

Summary of what is available from the document regarding "performance":

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems: Advantage Windows Workstation with FuncTool option K960265) based on:

• Design: PC-based Linux workstation, X-windows environment, standard Ethernet connection to MRI scanner.
• Technical Performance (qualitative descriptions):
  • Computation: Uses 32-bit float or integer, converts to lossless XPM format for display/transfer, re-computes output images from original data to prevent data loss, 16 bits-per-pixel depth input, 32-bits deep representations for computation.
  • Artifacts: Minimizes "phase breaks" in phase difference images by using real and imaginary MR images as inputs and full complex-phase-difference implementation. Mentions potential causes of artifacts (long echo times, patient motion) and general MRI best practices to minimize them.
• Indications for Use: Ability to retrieve, store, process, and display temporally dynamic MR data for analyzing intensity changes (e.g., contrast enhancement) or phase changes (e.g., temperature, angiography).

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring extensive de novo clinical or performance studies with predefined acceptance criteria for every new feature, especially for image processing software that provides information for a trained physician to interpret. The FDA's letter confirms that the device was found substantially equivalent to the predicate.

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