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LC ChromeFlow is a flowable light cure resin based dental restorative material which is indicated to be used for small restorations; extended fissure sealings; restorations of class III, IV and V and lining of cavities.

LC ChromeFlow is a light cure flowable radiopaque composite. LC ChromeFlow can be used for a lot of natural tooth shades due to its continuous color matching properties.

The provided FDA 510(k) summary for LC ChromeFlow does not contain any information about acceptance criteria or a study proving the device meets said criteria, in particular no information about AI algorithm performance.

The document is a standard 510(k) submission, focusing on establishing substantial equivalence to predicate devices based on intended use, chemical composition, and physical properties, as per ISO 4049. It does not refer to any AI/ML component or associated studies for performance evaluation against specific criteria.

Therefore, I cannot fulfill your request for:

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

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