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• Temporary inlay and onlay treatments of the cavity.
• Sealing of openings for implant screws.
• Relining material for temporary crowns and bridges.
• Covering of the gingival margin
• Fixing of resin matrix during filling placement.
• Block-out material for retentive ares in the dental arch, e.g. before taking impressions.

Once-Fil Flow is a light-curing filling material designed for temporary restorations. It serves as an interim solution before the placement of a final prosthesis, providing functions such as pulp protection and maintaining tooth position. The material is suitable for temporary fillings in prepared cavities and inlay/onlay cases.

To accommodate different clinical needs, Once-Fil Flow is available in two shades. The Yellow shade is ideal for anterior teeth, where esthetics are a priority, while the Blue shade provides clear visual contrast, making it easier to identify and remove before permanent restoration.

The application process involves preparing the tooth surface, applying an appropriate amount of material, and light-curing it. Once cured, the material can be finished and polished using conventional instruments.

The provided FDA 510(k) clearance letter and summary for "Once-Fil Flow" does not describe an AI medical device or an AI/ML software. Instead, it pertains to a dental resin material. Therefore, the request to describe the acceptance criteria and study proving the device meets those criteria for an AI device cannot be fulfilled from the provided text.

The information in the provided text focuses on the material characteristics and biocompatibility of a dental flowable resin. The regulatory context described is for a Class II medical device, product code EBF (Tooth Shade Resin Material), regulated under 21 CFR 872.3690.

The document highlights the basis for substantial equivalence to a predicate device (Clip Flow by VOCO GmbH, K153493) through:

• Identical Indications for Use: Temporary inlay/onlay, sealing implant screw openings, relining temporary crowns/bridges, covering gingival margin, fixing resin matrix, and block-out material.
• Similar Technological Characteristics: Light curing type, similar materials (with minor differences confirmed by performance and biocompatibility), same intended user, similar delivery method, same period of use and shelf-life.
• Performance Testing (Non-Clinical): Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Water Sorption/Solubility, Color and Color Stability, and Shore D Hardness, all tested in accordance with ISO 4049 and ISO 868.
• Biocompatibility Testing: ISO 10993 series tests including cytotoxicity, irritation, systemic toxicity, and skin sensitization.

No information regarding AI, machine learning, clinical image analysis, or human reader studies is present in the provided text. The request for details on sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, ground truth types, and training set information is not applicable to this specific device (a dental resin material) based on the supplied documentation.

Therefore, since the input document describes a physical dental material and not an AI/ML medical device, I cannot extract the requested information regarding AI acceptance criteria and study details.

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