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AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images.

AngioViz is an application which produces from a DSA series parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow.

The AngioViz application can be used to process DSA image data from any location in the human body for which DSA imaging is used.

The AW VolumeShare 5 is a stand-alone workstation with its own image database residing on its dedicated computer. The AW VolumeShare 5 workstation supports functions for image display, manipulation, and selective recording (either on film or on disk).

The AW VolumeShare 5 is intended to be used to create and review diagnostic evidence related to radiology procedures by trained and licensed physicians and/or qualified clinical/medical personnel. The device is not intended for diagnosis of mammography images

AW VolumeShare 5 workstation, like its predicate Advantage Workstation 4.3, provides a platform for a variety of other GE software medical devices to operate, all of which are cleared by FDA in their own names.

AngioViz is an option offered on AW Volume Share 5. It is an integrated post processing image analysis software dedicated to the application of vascular imaging on body vessels.

AngioViz is an application which produces from a DSA series parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow.

The AngioViz application can be used to process DSA image data from any location in the human body for which DSA imaging is used.

The provided 510(k) premarket notification for the GE Healthcare AW VolumeShare 5 with AngioViz Option does not contain acceptance criteria or a study proving that the device meets specific performance criteria.

Here's a breakdown of the information that is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance:

• Absent. The document explicitly states: "The subject of this premarket submission, AW VolumeShare 5 with AngioViz, did not require clinical studies to support substantial equivalence." This means there were no performance metrics defined or measured for this specific submission to demonstrate equivalence to a predicate device. The submission focuses on the technological equivalence and safety, not on specific performance claims measured against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Absent. Since no clinical studies were performed, there is no test set or associated sample size discussed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Absent. As no clinical studies were performed, there was no test set requiring expert-established ground truth.

4. Adjudication Method:

• Absent. No clinical studies, no adjudication method.

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

• Absent. The document explicitly states no clinical studies were required or performed. Therefore, no MRMC study was conducted or reported.

6. Standalone Performance Study:

• Absent. No standalone performance study was conducted or reported for the AngioViz option. The submission focuses on the AW VolumeShare 5 as a review workstation and the technological similarity of AngioViz to the predicate device's underlying technology.

7. Type of Ground Truth Used:

• Absent. Ground truth is not relevant in the context of this submission, which relies on technological equivalence rather than performance evaluation against a gold standard for specific diagnostic claims.

8. Sample Size for the Training Set:

• Absent. This submission does not describe any machine learning or AI models that would require a 'training set.' The AngioViz application is described as generating "parametric images representing maximum opacification, time to peak and combinations of those, to enable the user to more easily visualize characteristics related to vascular flow." This implies image processing and visualization techniques, not necessarily a trained AI model with a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

• Absent. As there is no training set mentioned, there is no discussion of how ground truth would be established for it.

In summary:

This 510(k) submission for the GE Healthcare AW VolumeShare 5 with AngioViz Option received FDA clearance based on substantial equivalence to a predicate device (Advantage Workstation 4.3 (K052995)). The justification for substantial equivalence primarily relies on:

• Technological Equivalence: Stating that "AW VolumeShare 5 with AngioViz option employs the same Technology as that of its predicate device."
• Compliance with Voluntary Standards: (as detailed in Sections 9, 11, and 16 of the submission, though these sections are not provided in the snippet).
• Quality Assurance Measures: Including Risk Analysis, Requirements Reviews, Design Reviews, Performance testing (Verification), Safety testing (Verification), and Final acceptance testing (Validation). However, the results of these tests and their specific acceptance criteria are not detailed in the provided pages.

No clinical studies were performed or deemed necessary to support this substantial equivalence determination. Therefore, the document does not contain the specific performance metrics, test sets, expert ground truth establishment, or comparative studies you requested.

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