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EConsole2 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, and mammographic applications). It is intended for both adult and pediatric populations.

EConsole2 is digital radiography operating console software. EConsole2 provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, EConsole2 acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.

This document, a 510(k) summary, lacks the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them. Specifically, it does not contain the specifics of a study conducted to prove the device's performance against acceptance criteria for an AI/CAD/software-as-a-medical-device (SaMD) product.

The EConsole2 is described as a Radiological Image Processing System (software), which "acquires and processes images" and "can utilize and transfer the digitalizing x-ray images for radiography diagnostic." However, the summary focuses on its equivalence to a predicate device (EConsole1) primarily based on shared software functions, DICOM compliance, and safety standards adherence.

The key statement regarding performance is: "The test results support that all the specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence." However, it does not provide the details of these "test results" or "acceptance criteria" in the context of diagnostic performance as would be expected for an AI-powered image analysis device.

The document explicitly states: "Clinical studies are unnecessary to validate the safety and effectiveness of the Radiological Image Processing System, EConsole2, the subject of this 510(k) notification." This strongly suggests that an MRMC or standalone performance study measuring diagnostic accuracy (e.g., sensitivity, specificity, AUC) was not performed or submitted as part of this 510(k) given their determination that clinical data was "unnecessary."

The "ECE Function" is mentioned as a new "optional" image processing feature that "normalizes the image brightness and contrast regardless of the exposed x-ray dose." While this is a form of image processing, the summary doesn't describe it as an AI/CAD function with specific performance metrics against an established ground truth for diagnostic purposes.

Therefore, I cannot provide the requested information about acceptance criteria, detailed study results, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/CAD device's diagnostic performance. The 510(k) appears to be based on substantial equivalence for a medical image management and processing system rather than demonstrating the performance of a novel AI-driven diagnostic aid.

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