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The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

The SOPIX series digital X-ray imaging systems are intended to be used by a dental practitioner. The sensor (located in the patient's mouth just like a silver film) captures the X-rays produced by the generator. Then it transmits this data to the computer to display the X-ray image on the screen.

Since the A.C.E technology affects exposure time, when used in combination with X-Mind Unity X-Ray generator, the SOPIX Inside and SOPIX2 Inside A.C.E feature is an automatic exposure control technology.

I am sorry, but the provided text from the FDA 510(k) summary for the SOPIX INSIDE and SOPIX2 INSIDE devices does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving device performance.

The document is a clearance letter from the FDA, confirming that the devices are substantially equivalent to legally marketed predicate devices. It covers regulatory information, product codes, and indications for use.

Crucially, it does NOT include details about:

• Acceptance criteria table and reported device performance: This type of information would be found in the manufacturer's performance studies, which are summarized within the 510(k) submission itself, but not typically in the FDA clearance letter.
• Sample size and data provenance for the test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results (effect size).
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

To find this type of information, you would typically need to refer to the full 510(k) submission (if publicly available, often through a Freedom of Information Act request or directly from the manufacturer), which contains the technical specifications and detailed study reports supporting the substantial equivalence claim. The provided document is merely the FDA's formal clearance notice.

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