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The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.

The EVA System (previously named the Sens-A-Ray System) has been modified to incorporate a new sensor component and docking station. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent Sens-A-Ray System described in K923067. The modifications are limited to changing the sensor from a CCD Sensor to a Complimentary Metal Oxide Semiconductor (CMOS) sensor and adding a docking station. As with the original Sens-A-Ray Sensor, the CMOS sensor when exposed to radiation captures the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized by a processor and sent to a computer screen for image presentation. The EVA System Sensor and supporting electronics are identical in intended use and fundamental technology to the parent Sens-A-Ray Sensor and supporting electronics.

The provided text is a 510(k) summary for the EVA Digital Dental Imaging System and a subsequent FDA clearance letter. It is a regulatory document focused on establishing substantial equivalence to a predicate device, not a study evaluating the device's performance against specific acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The document primarily states:

• The EVA Digital Dental Imaging System is intended for use with standard digital dental X-ray systems for system operation, archive data storage, input capture and enhancement, and patient data and support.
• It is a modification of the predicate Sens-A-Ray System, changing the sensor from a CCD to a CMOS and adding a docking station.
• The CMOS sensor offers a larger image area, higher resolution, and lower power requirements.
• The computer interface changed from ISA to USB.

The FDA clearance letter confirms that the device is substantially equivalent to legally marketed predicate devices, which is the regulatory standard for 510(k) applications. It does not include an independent performance study against acceptance criteria as would be found in a clinical trial report or a detailed engineering verification and validation document.

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