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The ARiX RAD Acquisition Console™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. The ARiX RAD Acquisition Console™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems.

The ARIX RAD Acquisition Console™ system is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only and users must be qualified to create and diagnose radiological image data.

The main functions of the ARiX RAD Acquisition Console™ system are as follows:

a) Acquisition and storage of digital X-ray images from a digital X-ray Detector.
b) Input Study information (patient information, exam information).
c) Management of stored (archived) images.
d) Image processing for enhancement of archived images.
e) Review of stored images.
Editing of images.
g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.)
h) For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) or a need to interface with installed X-ray system, the:
Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body . parts and positions.
Communication between Generator Console and ARIX RAD Acquisition Console™ . system.

The ARiX RAD Acquisition Console™ is software used together with a digital . X-ray image acquisition system that uses a digital detector and a Compact GMX RAD X ray generator.
The system allows the user to acquire, review, process, and store high . resolution images, up to 43 cm x 35 cm (17 in x 13.8 in), at 2880 x 2400 pixel resolution and 14 bits depth.
The ARiX RAD Acquisition Console™ provides digital images in compliance . with the DICOM 3.0 standard.

The provided text describes the ARiX RAD Acquisition Console™ as medical imaging software but does not contain information regarding specific acceptance criteria or a study proving its performance against such criteria in the context of diagnostic accuracy.

The nonclinical testing section states: "The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the ARiX RAD Acquisition Console™ software in each operational mode and followed the process documented in the System Validation Test Plan. Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

This statement confirms that internal acceptance criteria were met through nonclinical testing (factory assessment, validation test plan), but it does not detail those criteria or the results in a way that would allow for a table of acceptance criteria and reported device performance related to diagnostic efficacy. It focuses on the software's functional performance (input/output, actions, DICOM compatibility, etc.) rather than its performance in detecting or characterizing disease.

Therefore, I cannot fulfill your request for the detailed table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details related to diagnostic performance, as this information is not present in the provided 510(k) summary. The document focuses on establishing substantial equivalence based on technical characteristics and intended use, rather than on a clinical performance study with defined diagnostic endpoints.

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