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SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.

SIDEXIS 4 combines the two Sirona products GALAXIS and SIDEXIS XG and now integrates 2D and 3D functions. New functions have been implemented (e.g. comparison of two volumes, comparison of two 2D projections).

The provided documentation for Sirona Dental Systems SIDEXIS 4 does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria.

Here's a breakdown of why this information is missing based on the provided text:

• Section 7. PHYSICAL AND PERFORMANCE CHARACTERISTICS: States "Not applicable." This indicates that no specific performance characteristics or acceptance criteria were defined or tested in the context of a 510(k) submission that typically focuses on substantial equivalence.
• Section 10. Clinical Testing: States "Clinical tests have not been performed." This explicitly indicates that no clinical studies were conducted to assess the device's performance against clinical endpoints or acceptance criteria.
• Section 9. Non-clinical Testing: Mentions that "The SIDEXIS 4 system functions have been tested" and "Additional tests with technicians and physicians have been performed to compare images from SIDEXIS XG/GALAXIS with SIDEXIS 4." While this indicates some testing, it doesn't describe quantitative acceptance criteria or a formal study to prove performance. The nature of these tests appears to be focused on functional equivalence and user perception rather than quantifiable performance metrics.
• Section 11. Conclusion: States that the device is deemed "safe and effective to perform its intended use and is substantially equivalent to the predicate devices" based on a comparison of intended use, indications, principle of operation, features, and technical data. This reinforces that the submission relies on substantial equivalence rather than meeting specific performance criteria.

Therefore, since the device's approval seems to be based on substantial equivalence to predicate devices (SIDEXIS XG, GALAXIS, Cybermed OnDemand3D) rather than meeting predefined performance criteria through a specific study, the requested information cannot be extracted from this document.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size for the test set and data provenance: Not applicable as a formal performance test set and study were not conducted.
3. Number of experts used to establish ground truth and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance study: Not conducted, as the device is a PACS system with image viewing capabilities, not an AI algorithm with standalone performance metrics.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (this is an imaging system, not an AI model that undergoes training).
9. How ground truth for the training set was established: Not applicable.

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