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Aegis Pit & Fissure Sealant with ACP is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Aegis Pit & Fissure Sealant with ACP is available in opaque and tinted shades, when different shades are indicated for use.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Aegis® Pit & Fissure Sealant." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML or diagnostic devices.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls but does not include technical study details.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The requested information types (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are characteristic of performance evaluations for diagnostic or AI/ML-driven devices, which are not described in this regulatory clearance letter for a dental sealant.

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