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This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

The Alphenix, INFX-8000C/B, V8.0, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

The provided text is a 510(k) summary for the Alphenix, INFX-8000C/B, V8.0 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance against those criteria.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from the provided text.

The document states that:

• "Risk analysis and verification/validation testing conducted through bench testing demonstrate that the established specifications for the device have been met." (Page 6)
• "System evaluation of image quality: Image quality metrics were performed, utilizing phantoms, to asses spatial resolution, low-contrast resolution/dynamic range, fluoroscopic still image resolution/dynamic image resolution/afterimage, artifacts/contrast/dynamic range of DSA, reconstructed image spatial resolution in 3D-DA acquisition, reconstructed image spatial resolution in 3D-DSA acquisition, reconstructed image spatial resolution in AlphaCT Vessel acquisition, reconstructed image spatial resolution in AlphaCT acquisition, reconstructed image density resolution in AlphaCT acquisition." (Page 6)
• "Evaluation of items supported to improve image quality: Image quality metrics were performed, utilizing phantoms, to assess image quality improvements, improvement in fluoroscopy roadmapping and multiphase AlphaCT acquisition." (Page 6)
• "This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." (Page 6)

These statements indicate that technical performance evaluations were conducted using phantoms and bench testing to ensure the modified device maintained or improved upon the image quality metrics of the predicate device. However, specific acceptance criteria values (e.g., "spatial resolution should be X lp/mm") and the device's reported performance against these criteria are not detailed in this summary. There is no mention of clinical studies involving human readers or patient data for evaluating diagnostic performance. The study described is a technical verification and validation against specified engineering and image quality parameters, not a clinical effectiveness study.

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