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The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.

The Tio-h Digital Radiography Sensor is a digital radiography imaging system. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen.

This FDA 510(k) clearance letter for the "Tio-h Digital Radiography Sensor" (K153144) does not contain information about acceptance criteria, device performance tables, study details like sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Substantial Equivalence Determination: Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Stating how the device is intended to be used (for basic dental intra-oral x-ray imaging by qualified dental and healthcare professionals).
• Regulatory Information: Details about regulatory classification, applicable regulations, and responsibilities.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or study details using only the provided text. This information would typically be found in a separate section of the 510(k) submission, such as a performance testing summary or clinical study report, which is not part of this specific clearance letter.

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