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Materialise Dental's SimPlant Ortho; Vistadent 3D software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also used as a software system for simulating/evaluating orthodontic treatment i.e. dental bite options.

Simplant Ortho provides a method of segmenting CT images. This file allows the individual patient's CT image to be assessed in a three-dimensional way, to see the anatomical structures without patient contact or surgical insult. It includes features for cephalometric analysis of the patient and orthodontic treatment simulation. Additional information about the exact geometry of the tooth surfaces can be visualized together with the CT data and orthodontic procedures with TADs (temporary anchorage devices) can be simulated.

Osteotomies and distractions can be visualized to simulate the desired relation of both jaws and the result on the soft tissue profile of the patient can be visualized.

The output file is intended to be used in conjunction with diagnostic tools and expert clinical judgment.

SimPlant Ortho; Vistadent 3D is software for simulating/evaluating orthodontic treatment (i.e. dental bite options) programmed in C++ language and running on the Windows operating system.

The provided text describes a 510(k) premarket notification for the "SimPlant Ortho; Vistadent 3D" software. However, it does not contain specific acceptance criteria for the device's performance, nor does it detail a study that proves the device meets such criteria in terms of quantitative metrics (e.g., accuracy, sensitivity, specificity, or error rates).

The "TESTING & VALIDATION" section merely states:
"The software is thoroughly tested in accordance with a documented test plan. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users."

This is a general statement about their validation process but lacks the specifics requested in your prompt regarding acceptance criteria and performance data.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or human reader effectiveness because this information is not present in the provided document.

If you have other documents that contain these details, please provide them, and I would be happy to analyze them.

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