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MODUS IMF Screws 2.0 are indicated for temporary use as a supplementary method in reduction and fixation of dislocated or fractured bone fragments, condylar fractures and restoration of occlusion in orthognathic or orthodontic procedures.

The MODUS IMF Screws 2.0 are provided in two screw types with different plateau geometries and various lengths. Both designs are self-drilling with cross heads and include holes for insertion of a wire parallel to the cross head as well as grooves for the attachment of elastic bands.

The provided text is a 510(k) Summary for the MODUS® IMF Screws 2.0. This document outlines the regulatory submission for a medical device and describes its intended use and equivalence to existing devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations related to a study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting performance study data against defined acceptance criteria.

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