(51 days)
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.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.