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CS Model+ is intended for use as a front-end software tool for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design options, including dental casts and orthodontic appliances. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of CS Model+ requires the user to have the necessary training and domain knowledge in the practice of orthodontics.

CS Model+ is a software that allows practitioners to apply software imaging tools for management of orthodontic models, detailed analysis, treatment simulation and virtual appliance design. CS Model+ allows design of virtual models, also known as virtual dental casts. Those can be exported as STL or PLY files which may be used for fabrication of orthodontic models (dental casts). Then, which may be used to fabricate sequential aligner trays or retainers. The production of physical models and the other fabrication processes, such as thermoforming of aligner, is out of scope of Carestream Dental's manufacturing process. Those fabrication processes are done by the user and is under their sole control and responsibility.

CS Model+ is intended to be used with the following Carestream Dental's digital imaging devices including:

• -Intraoral scanners;
• -Extraoral devices with 3D object modality.

CS Model+ allows healthcare professionals to do the following:

• -Display digital 2D or 3D views of digital 3D models;
• Adjust the color and opacity of digital 3D models; -
• -Make indicative measurements of digital 3D models;
• Print and export images of digital 3D models; -
• -In a digital model, automatically detect the teeth cervical margins, teeth numbering and mesio distal orientations;
• -Generate an orthodontic report;
• Create virtual setups; -
• -Automatically generate virtual setups suitable for aligners treatment;
• Make automatic and customizable export of virtual models; -
• -Manage the intermediate steps;
• -Make refinement during treatment.

The provided text is a 510(k) Summary for the medical device CS Model+. It outlines the device's indications for use and compares it to a predicate device, Ortho System™. However, the document explicitly states that clinical testing was not performed and is not a requirement for this submission.

Therefore, the input does not contain the information requested in your prompt regarding acceptance criteria, reported device performance from a study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth types for training and testing sets.

The document focuses on nonclinical testing (software verification and validation) to establish substantial equivalence, stating: "Testing confirmed that CS Model+ is stable and operating as designed." and "All test results have been reviewed and approved, showing the CS Model+ software to be substantially equivalent to the primary predicate Ortho System™ (K171634)."

Without a clinical study, it's impossible to create the table and answer the detailed questions about acceptance criteria and device performance based on the provided text.

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