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Intraoral dental x-ray machine, wall mounted system that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Sanko dental intaoral x-ray series 70 model_W1070-P

I apologize, but the provided text from the FDA 510(k) K972921 for the Sanko Dental Intraoral X-Ray Series 70 Model W1070-P does not contain any information regarding acceptance criteria, device performance metrics, or study details as outlined in your request.

The document is a clearance letter stating that the device is substantially equivalent to a pre-amendment device and outlines regulatory compliance information and contact details. It does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test or training sets.
• Details on expert involvement, adjudication methods, or ground truth establishment.
• Any mention of multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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