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The DRX-Evolution Plus is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging. This device also supports Dual Energy chest imaging. The Dual Energy feature is not to be used for imaging pediatric patients.

The DRX-Evolution Plus is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wall-mounted image receptors/detectors for upright imaging, various models of tube support devices, x-ray tube, and collimator (beam-limiting device). In addition to general radiography applications, the system also includes the optional Dual Energy functionality. The DRX-Evolution Plus can be used with digital radiography (DR) and computed radiography (CR) receptors. "Smart" Features are added to the DRX-Evolution Plus system to provide remote exam set-up capabilities for existing functions of the DRX-Evolution Plus system. These remote capabilities simplify exam set up and improve workflow for the operator while preparing for the patient exposure. The "smart" features, described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality.

The provided FDA 510(k) document for the Carestream Health, Inc. DRX-Evolution Plus System (K233381) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically regarding AI/algorithm performance.

The document discusses the substantial equivalence of the DRX-Evolution Plus system to a predicate device (K190330), focusing on hardware components, new integrated detectors, and workflow enhancements referred to as "Smart" features (Real-time Video Assistance, Long Length Imaging, Collimation from User Interface, Patient Picture).

The "Smart" features described are workflow improvements that seem to involve remote control and visualization, not an AI/algorithm that performs diagnostic or detection tasks requiring rigorous performance criteria and clinical validation studies per the questions asked. The document explicitly states: "The 'smart' features, described below, are designed to reduce the technologist's manual tasks and to speed up workflow for existing features of the system. Implementation of these features does not change the intended use of the system and does not affect the Dual Energy functionality."

Therefore, I cannot extract the information requested about acceptance criteria for an AI/algorithm's diagnostic performance, sample sizes used for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance from this specific document.

The document indicates:

• Non-clinical testing was performed for the "Smart" Feature user options, and these tests "indicated that the subject device as described in this submission meets the predetermined safety and effectiveness criteria." However, it does not specify what those criteria were for these workflow enhancements beyond general safety and effectiveness.
• Detector integration testing involved "functional testing, installation testing, media verification tests, performance tests, regression tests, risk mitigation testing, and serviceability testing." For the Lux 35 detector, "comprehensive image quality tests, vacuum testing to validate its liquid ingress (IP57) requirement, and Dual Energy functionality and performance testing" were done.

Given the nature of the device (a general diagnostic X-ray system with workflow enhancements), it's highly probable that the acceptance criteria and validation studies are related to hardware performance, image quality, electrical safety, usability, and compliance with recognized standards (IEC, ISO), rather than the diagnostic accuracy of an AI algorithm.

In summary, the provided text does not contain the information requested to answer the questions about AI/algorithm acceptance criteria and performance studies because the "Smart" features described are workflow enhancements, not diagnostic AI algorithms.

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