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The IMAX CEPH digital X-ray sensor is intended to capture extra oral x-ray images of a patient's head when exposed to X-rays for diagnostic purposes.

The process is automatic and continues transmitting the digital image to a Personal Computer VIA USB interface.

I am sorry, but the provided text is a 510(k) summary from the FDA, which is a premarket notification for a medical device. It does not contain information about acceptance criteria or a study proving device performance in the detailed manner you've requested.

The document primarily focuses on:

• Confirming the substantial equivalence of the "Imax CEPH Digital X-ray Sensor" to a legally marketed predicate device.
• Stating the intended use of the device: "to capture extra oral x-ray images of a patient's head when exposed to X-rays for diagnostic purposes."
• Mentioning that the process is automatic and transmits digital images via USB.

Therefore, I cannot provide the requested information in the table format because the necessary data (acceptance criteria, specific performance metrics, study design details, ground truth establishment, sample sizes, expert qualifications, etc.) is not present in this document.

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