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This device is intended to be used by all medical and dental personnel to store all patient medical or dental records on CD, Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of transmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user to use digital zoom-in features to enlarge an x-ray film/images, or any type of document for closer examination.

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This is a 510(k) clearance letter and an intended use statement, which do not contain the detailed study information required to answer the questions about acceptance criteria and device performance. The documents confirm the device (Maestro Digital Image and Patient Record Storage System) received 510(k) clearance in 1997 for storing patient medical/dental records on digital media and transmitting them, as well as providing zoom-in features for images.

Therefore, I cannot provide the requested information based on the provided text. To answer these questions, I would need access to the actual 510(k) submission, which would include performance data, study designs, and acceptance criteria.

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