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The KODAK CR-7400 Digital Radiography System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.

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The provided text is a 510(k) premarket notification letter from the FDA to Kodak Health Group regarding the KODAK CR 7400 Digital Radiography System. This document approves the device based on substantial equivalence to a predicate device but does not contain information about the acceptance criteria, specific study designs, or detailed performance data typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot extract the information required to answer your request. The document 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 (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."

This indicates that the approval is based on equivalence to existing devices, not necessarily on a detailed study proving it meets specific acceptance criteria in the manner you've outlined for AI or diagnostic performance studies. The 510(k) process often relies on demonstration of similar technical characteristics and performance to legally marketed predicate devices.

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