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MagicFil is a dual cure compomer restorative material with additional colors and glitter for the restoration of deciduous teeth.

MagicFil is a dual cure (chemical and/or light cure) restorative material with an aesthetic glitter effect for use as a semipermanent restorative material (e.g., for deciduous teeth).

The provided text describes a dental restorative material, MagicFil, and its 510(k) summary for FDA clearance. However, it does not include information about a study proving the device meets acceptance criteria, an acceptance criteria table, or details regarding AI/ML device performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that the submission is an "Abbreviated 510(k)" and demonstrates conformity with ISO Standard 4049:2000 Dentistry - Polymer-based filling, restorative and luting materials. This indicates that the device's safety and performance were evaluated according to the standards outlined in that ISO document, rather than through a clinical study with an AI component or complex ground truth establishment as typically seen in AI/ML device submissions.

The conclusion simply states: "Based on its indications for use, technological characteristics, and comparison to predicate devices, the MagicFil material has been shown to be safe and effective for its intended use." This suggests equivalency was established through comparison to predicate devices and adherence to relevant standards, not through a performance study against specific acceptance criteria in the way you've described.

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