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The CDMx-H is intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structure by using scanned dental x-ray images sent through the digital x-ray sensor.

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The provided document is a 510(k) clearance letter from the FDA for a device named CDMx-H. It states that the device is "substantially equivalent" to legally marketed predicate devices. Unfortunately, this document does not contain the specific acceptance criteria, performance data, or details about the studies conducted to demonstrate its performance.

The FDA 510(k) clearance process primarily focuses on substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or if the technological characteristics are different, that the differences do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device. It does not typically require the submission of detailed performance studies in the same way a PMA (Premarket Approval) might.

Therefore,Based on the provided text, I cannot extract the information required to populate the table and answer your questions directly. The document is solely an FDA clearance letter and does not include the details of the studies conducted to establish the device's performance against specific acceptance criteria.

To answer your request, I would need access to the actual 510(k) summary or the full submission document, which would detail the testing and performance data.

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