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The RetroPan CCD -- TWAIN - USB Digital X-ray Conversion Kit from Video Dental Concepts, Inc. is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.

The RetroPan CCD - TWAIN - USB sensor produces instant digital images. The RetroPan CCD - TWAIN - USB allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K-12439, which gives post processing capabilities to enhance images.

It is faster to obtain images with the RetroPan CCD – TWAIN – USB Retrofit Kit than from conventional film since no chemical nor any other type of processing is required.

The RetroPan CCD - TWAIN - USB Digital X-ray Conversion Kit is a sensor connected to the DentalEye software, #K-12439.

This FDA 510(k) clearance letter for the RetroPan CCD - Twain - USB Digital X-ray Conversion Kit does not contain the information requested about acceptance criteria, study details, or ground truth establishment.

The document primarily focuses on:

• Substantial Equivalence: Affirming that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Compliance: Outlining the general controls and regulations the device must adhere to (e.g., registration, listing, good manufacturing practices, labeling).
• Intended Use: Stating the device's purpose as an instant digital X-ray imaging system for human oral tissue and teeth, allowing for reduced exposure time and post-processing capabilities.

Therefore, I cannot provide the requested table and study details based on the provided text. The letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates a review of the submission, not a detailed description of the studies and acceptance criteria within the letter itself. Such details would typically be found within the 510(k) submission document, which is not provided here.

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