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GrandioSO Light Flow is intended for use for:

• Filling/characterisation of small cavities
• Filling/characterisation of class III, IV, and V cavities
• Extended fissure sealing
• Blocking out undercuts
• Lining or coating cavities
• Repairing fillings, veneers and temporary restorations
• Luting translucent prosthetic pieces

Not Found

The provided text is an FDA 510(k) clearance letter for a dental material, "GrandioSO Light Flow." It does not contain any information about acceptance criteria or a study proving the device meets those criteria, specifically in the context of an AI/ML-driven medical device.

The document discusses:

• Device Name: GrandioSO Light Flow
• Regulation Number: 21 CFR 872.3690 (Tooth Shade Resin Material)
• Regulatory Class: Class II
• Product Code: EBF
• Indications for Use: Filling/characterization of small, Class III, IV, and V cavities; extended fissure sealing; blocking out undercuts; lining or coating cavities; repairing fillings, veneers, and temporary restorations; and luting translucent prosthetic pieces.
• General regulatory information: Such as annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration, and adverse event reporting.

Since the request is about acceptance criteria and a study for an AI/ML-driven medical device, and this document describes a dental resin material, it does not contain the information needed to fulfill the request. Therefore, I cannot construct the table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

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