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The KaVo In eXam Intraoral X-ray device is to be used exclusively within dentistry as an extraoral source of x-rays.

The KaVo In eXam Intraoral Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area. The KaVo In eXam Intraoral Dental X-Ray System is comprised of the following main components: X-ray tube head, Yoke with user interface capabilities, Articulated arm, Horizontal arm, Electronic control unit, Wall mount, Cone. The power supply is regulated to provide a fixed 70kVp, and the x-ray target current is fixed at 7mA. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of expsure time is 0.012 through 1.88 seconds.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the KaVo In eXam Intraoral Dental X-Ray System, issued by the FDA in 2005.

While it mentions "Performance testing to meet product specifications" and "Effective clinical image exposures" as demonstrations of safety and effectiveness, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number of experts, adjudication methods, or specific ground truths for any studies.
• Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
• Sample size or ground truth establishment for a training set.

The document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use, similar materials, design, operational, and functional features, rather than presenting a detailed study proving specific acceptance criteria.

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