(221 days)
NemoCast is intended for supporting the diagnostic and treatment plan processes for orthodontic procedures related to minor anterior tooth movements; it provides tools for management of orthodontic models, systemic inspection, detailed analysis, treatment simulation and virtual appliance design options (export of models) based on 3D models of the patient's dentition before the start of an orthodonic treatment. It can also be applied to evaluate if the outcome is consistent with the planned/desired treatment objectives.
NemoCast requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
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I apologize, but the provided text from the FDA 510(k) clearance letter for NemoCast does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the level of detail requested.
The letter is a formal notification of substantial equivalence, and while it references the device and its indications for use, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or training sets.
- Data provenance (country, retrospective/prospective).
- Details about experts for ground truth establishment (number, qualifications, adjudication methods).
- Information about MRMC studies or effect sizes.
- Standalone algorithm performance data.
- Specifics on ground truth types or how it was established.
The document primarily focuses on the regulatory aspects of the clearance (e.g., product code, regulation number, substantial equivalence determination, general controls, and compliance requirements).
To answer your request thoroughly, I would need access to the full 510(k) submission, which typically includes detailed validation studies, performance data, and methodology. This information is not present in the provided FDA clearance letter.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.