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For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.

The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.

The provided text describes a 510(k) submission for a dental bonding agent, Tokuyama America - One-Up-Bond F. This document is a regulatory submission to the FDA, not a study report detailing clinical performance or acceptance criteria of an AI device. The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, and specific study designs (MRMC, standalone), are typically found in detailed clinical or analytical validation studies for software or AI medical devices.

The text does not contain any information about:

• Acceptance criteria for performance metrics.
• Reported device performance (e.g., sensitivity, specificity, accuracy).
• Any study (clinical or otherwise) that proves the device meets specific acceptance criteria based on performance metrics.
• Sample sizes for test or training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
• AI components or standalone algorithm performance.
• How ground truth was established.

Instead, the document focuses on:

• Device Description: A resin tooth bonding agent for use with light-cured composite resins to enhance bonding and seal exposed dentin/root surfaces.
• Intended Use: For use by dental practitioners in general dentistry, not OTC.
• Regulatory Equivalence: Stating that the product is substantially equivalent to various marketed bonding agents, including Tokuyama's Tokuso Mac Bond II (K980058), and has received Japanese Government approval.
• FDA Clearance: An FDA letter granting 510(k) clearance based on substantial equivalence to a predicate device, allowing it to be marketed.

Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert details, or study designs, as this information is not present in the provided text. The document pertains to a traditional medical device (a dental material) and its regulatory clearance process, not an AI/software as a medical device (SaMD) that would typically involve the types of performance validation studies described in the prompt.

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