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Grengloo is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.

Grengloo is a chromatic orthodontic bonding adhesive. Grengloo is designed specifically for use with metal brackets; however, bonding of all appliances including ceramic and plastic are indicated. This single paste bonding adhesive has a green color that enhances ease of use, specifically during bonding and post treatment adhesive remnant removal procedures. During treatment, the patient's body temperature is above the color transition temperature and the adhesive takes on the color of the enamel. Grengloo has very fast light cure properties and achieves high strength allowing active archwires to be placed immediately. Grengloo is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques.

This document is a 510(k) premarket notification for a new orthodontic bonding adhesive called "Grengloo." The submission focuses on demonstrating substantial equivalence to a previously cleared device (Blugloo) rather than providing detailed performance studies with acceptance criteria in the typical sense of a diagnostic or AI-driven device.

Therefore, the requested information elements related to acceptance criteria, detailed study design, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or available within this provided document.

This document describes a medical device submission seeking market clearance based on substantial equivalence to a predicate device, not, a performance study with detailed acceptance criteria for a new clinical claim or an AI algorithm.

Here's a breakdown of why this information is not present in the provided text:

1. Nature of the Device: Grengloo is an orthodontic bonding adhesive, a material. Its "performance" is primarily assessed through material properties and clinical bonding success, not typically through diagnostic accuracy metrics like sensitivity or specificity that would have explicit acceptance criteria tables.
2. 510(k) Premarket Notification: This type of submission (K061481) aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This often relies on comparing material specifications, intended use, and general performance characteristics to the predicate, rather than extensive, new clinical trials against specific, quantitative acceptance criteria.
3. Lack of AI Component: The device is a physical adhesive, not an AI or diagnostic tool. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," and "MRMC studies" are not relevant to its evaluation or the information typically required for its clearance.

In summary, the provided document does not contain the information requested because the device type (orthodontic bonding adhesive) and the regulatory submission pathway (510(k) for substantial equivalence) do not necessitate such detailed performance study reporting in the context of diagnostic AI tools.

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