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The Definium Pace Select ET is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This device is not intended for mammographic applications.

The Definium Pace Select ET Radiography X-ray System is designed as a modular system with components that include a 2-axis motorized tube stand with tube and auto collimator assembled on an elevating table, a motorized wall stand, a cabinet with X-ray high voltage generator, a wireless access point, wireless detectors, an acquisition workstation including a monitor and control box with hand-switch. The system generates diagnostic radiographic images which can be reviewed or managed locally and sent through a DICOM network for reviewing, storage and printing.

By leveraging platform components / design, Definium Pace Select ET is similar to the predicate Definium Pace Select (K231892) and the reference Discovery XR656 HD (K191699) with regards to the user interface layout, patient worklist refresh and selection, protocol selection, image acquisition, and image processing based on the raw image. This product introduces motorized tube stand (vertical and tube angulation) instead of manual tube stand of the predicate. The high voltage generator is new and is backwards compatible to the predicates high voltage generator. This product also introduced Image Pasting on Table and Wall Stand Mode, Auto tracking for Wall Stand, Auto Angulation, Camera Workflow, DAP software calculation, Siemens LED collimator and LCD touch screen console. The other minor changes include updates to components due to obsolescence.

The provided document is a 510(k) premarket notification for a medical device called "Definium Pace Select ET." It describes the device, its intended use, and compares its technological characteristics to a predicate device ("Definium Pace Select") and a reference device ("Discovery XR656 HD").

However, this document does not contain any performance data or details of a clinical study that proves the device meets specific acceptance criteria based on AI or human reading performance.

The "PERFORMANCE DATA" section explicitly states: "The Definium Pace Select ET does not contain clinical testing data." Instead, it lists non-clinical tests performed, such as Risk Analysis, Requirements Reviews, Design Reviews, and various levels of verification testing (unit, integration, performance, safety, simulated use). These non-clinical tests are aimed at confirming the safety and effectiveness of the device as it relates to changes from the predicate, rather than evaluating specific clinical diagnostic performance metrics with a test set, ground truth, and human readers.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided input does not contain this information.

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