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lonoStar Molar is intended for use as:

• Restorations of non occlusion-bearing class I cavities
• Semi-permanent restorations of class I and II cavities
• Restorations of cervical lesions, class V cavities, root caries
• Restorations of class III cavities
• Restoration of deciduous teeth
• Base/liner
• Core build-up
• Temporary restorations

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a dental cement called "IonoStar Molar." It is not a study report or clinical trial document that details acceptance criteria and device performance in the context of an AI-powered medical device. Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size and ground truth establishment.

The document discusses the regulatory classification (Class II), product code (EMA), and indications for use for a dental cement. It focuses on the substantial equivalence determination to a predicate device, which is a regulatory pathway for certain medical devices, rather than a detailed performance study for an AI algorithm.

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