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This x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the "RX DC" device.

The document is a 510(k) premarket notification letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, product classification, and general controls. It also includes the "Indication for Use" for the device.

However, it does not contain the specific details requested in your prompt, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• Type of ground truth used.
• How ground truth for the training set was established.

This kind of detailed performance study information is not typically included in the FDA's 510(k) clearance letter itself, but would be part of the documentation submitted by the manufacturer to the FDA for review.

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