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DynaCT is an x-ray imaging software option, which allows the reconstruction of twodimensional images acquired with a standard angiographic C-arm device into a threedimensional image format.

DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

The DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT provides extended visualization capability. An increased number of acquired and post processed images results in an improved visualization of soft tissues. This improved visualization is comparable to CT images.

The provided text, a 510(k) Summary for the Siemens DynaCT, does not contain specific information regarding a study with acceptance criteria and reported device performance. The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, I cannot provide the requested information in the format given, as the study details, acceptance criteria, ground truth, and other specific performance metrics are not included in the provided text.

The document states: "In summary, Siemens is of the opinion that DynaCT does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices." This suggests that the primary method of demonstrating safety and effectiveness was through comparison to existing cleared devices rather than a detailed performance study with explicit acceptance criteria.

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