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Blue Sky Plan is intended to be used as conversion software for Computed Tomography (CT) generated DICOM images into a format that allows a dentist to assess the anatomic topography of the maxilla and mandible as well as location of important structures. It allows the information to be used for pre-surgical treatment planning of dental implant procedures. The Blue Sky Plan software is deployed on standard personal computer hardware using a Windows operating system.

Blue Sky Plan™ is dental imaging software which loads DICOM images and provides 3D visualization. 2D image reformation for surgical implant planning and stent fabrication, which allows the virtual position of implants from the images supplied by computerized tomography.

The provided text is a 510(k) summary for the medical device "Blue Sky Plan," a 3D Dental Image Processing Software. It outlines the device's description, indications for use, and a comparison to predicate devices, ultimately concluding substantial equivalence.

However, the document does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria. It states that "Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission," implying a comparison to predicate devices was performed, but no specifics of this comparison or any standalone performance study are provided.

Therefore, I cannot populate the requested table and sections with information directly from the provided text.

Based on the absence of explicit information in the provided document, the following points cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or reported device performance metrics are mentioned.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
4. Adjudication method for the test set: No test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study is described. The device is software for image visualization and planning, not explicitly "AI" in the modern sense or assistance to human readers in a diagnostic capacity beyond providing 3D views.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study is described.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training set is described.
9. How the ground truth for the training set was established: No training set is described.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological compatibility, without detailing specific performance studies or acceptance criteria for a new device evaluation.

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