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The DirectRay™ Operator Console has application whenever the transmission of radiographic images and associated patient text data is desired to take place from an input device, such as any radiographic equipment which uses the DirectRay™ device, to any output device, such as hardcopy, softcopy, or archive devices.

The DirectRay™ Operator Console is that device, which when used with any X-ray generating equipment and the DirectRay™ device (Sterling Diagnostic Imaging Direct Radiography™ ' K#973206) allows the synchronization of the ready states of the DirectRay™ device and the X-ray generator, and allows the operator to acquire, preview and transmit image and associated text data along with exam administration report capabilities. In one version, this device will also integrate these functions with the typical functions of an X-ray console eliminating the need for a separate X-ray console. This device is located in the control booth and will usually be housed in a specially designed cabinet. An optional feature of the DROC is the ability to link the digital image with the hospital information/radiology information systems (HIS/RIS).

I am sorry, but the provided text does not contain information about the acceptance criteria for the device, any study proving it meets these criteria, or detailed performance metrics. The document focuses on the 510(k) summary for the "DirectRay™ Operator Console," describing its intended use, classification, comparison to predicate devices, and the FDA's clearance.

Therefore, I cannot provide a response with the requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs without AI assistance
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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