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The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

The provided document is a 510(k) clearance letter for the Swissray Medical AG ddRFormula, indicating substantial equivalence to legally marketed predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's diagnostic accuracy or effectiveness.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process rather than specific performance data.

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