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The Varex Nexus DR Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The Nexus DR Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hard-copy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The major system components include an image receptor, computer, monitor and imaging software.

The Varex Nexus DR Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. Nexus DR™ Digital Xray Imaging System (with vSharp™) is designed to support general radiographic (excluding fluoroscopy, angiography, and mammography) procedures through a single common imaging platform.

The modified device consists of an X-ray imaging receptor, computer, monitor, and the digital imaging software and the optional vSharp software.

The Nexus DR™ Digital X-ray Imaging System (with vSharp™) is a configurable product platform designed to allow Varex to leverage the common components of digital X-ray imaging systems from which the following medical modalities can be served: General Radiography (excluding fluoroscopy, angiography, and mammography). Nexus DR™ Digital X-ray Imaging System (with vSharp™) is then configured to function on a computer with modality specific components, functionality and capabilities to complete the specific product package.

Like the predicate device, the modified Nexus DR™ Digital X-ray Imaging System (with vSharp™) is in a class of devices that all use similar technology to acquire digital radiographic images. These devices convert X-rays into visible light that shines onto a TFT array, which converts the visible light into a digital electronic signal. This process is ultimately used for the same purpose as Radiographic film, to create an X-ray image.

Identical to the predicate device, the modified device is capable of interfacing with flat panel detectors in v Trigger Mode or RAD Mode utilizing an external I/O box to interface with compatible X-ray generators, in non-integrated mode. The modified device also retains the ability to apply the grid suppression feature.

Similar to the already cleared Nexus DR™ Digital X-ray Imaging System with Integrated Generator the modified device, Nexus DR™ Digital X-ray Imaging System (with vSharp™), has the same intended use for the DR application. The modified device, however, adds vSharp™ scatter correction algorithm into the Nexus DR Software, the image contrast is enhanced and the images produced have similar detail contrast as images acquired with an anti-scatter grid. The Nexus DR Digital X-ray Imaging System can then store the images on the local computer, archive them to CD/DVD media, transfer them to Hard Copy format via DICOM printers, or transfer them to PACS reviewing stations in DICOM format.

The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets those criteria for the Nexus DR Digital X-Ray Imaging System with vSharp. It mentions "Validation was completed in accordance with the Validation Protocols included with this submission" and "Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met". However, specifics of these protocols, test methods, and the actual performance results against acceptance criteria are not provided.

The document states:

• "No clinical testing was performed as a result of this modification."
• "However, both Usability Testing and Image Comparisons were performed and the results can be found in VOL 018 Appendix R Clinical Data." (This Appendix R is not provided in the input text.)

Therefore, I cannot extract the requested information regarding detailed acceptance criteria, device performance, sample sizes, expert involvement, or grand truth establishment directly from the provided text.

Based on the available information, I can only state that while the document claims acceptance criteria were met and validation was performed, the specifics of these items are not detailed within the provided pages.

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