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• Anterior restorations (class III and IV)
• Class V restorations
• Posterior restorations (class I and II)
• Reconstruction of damaged anterior teeth
• Splinting of mobile teeth
• Veneering of discoloured anterior teeth
• Extended fissure sealing
• . Repair of factes
• Extraoral fabrication of inlays / onlays

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the LC Glossfill XR device does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/ML-based medical device.

The document is a standard FDA clearance letter for a dental material (Tooth Shade Resin Material). It discusses:

• The device name (LC Glossfill XR)
• Regulation number and name (21 CFR 872.3690, Tooth Shade Resin Material)
• Regulatory class (Class II)
• Product code (EBF)
• Date of clearance
• General controls provisions of the Act (registration, listing, GMP, labeling)
• Contact information for FDA resources
• Indications for Use (anterior/posterior restorations, class V, reconstruction, splinting, veneering, fissure sealing, repair, extraoral fabrication of inlays/onlays)

There is no mention of:

• Any AI/ML component or software
• Acceptance criteria for an AI/ML system
• Device performance data or metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test or training sets
• Ground truth establishment
• Expert involvement or adjudication
• MRMC studies
• Standalone algorithm performance

Therefore, I cannot extract the requested information from this document. If you have a document related to an AI/ML medical device that includes such study details, please provide that.

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