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D3 Chroma is a light-cured orthodontic bonding adhesive and is intended to be used for the attachment of orthodontic appliances to teeth.

D3 Chroma is a chromatic orthodontic bonding adhesive. D3 Chroma is designed specifically for use with Ormco Damon 3 and Spirit brackets, however bonding of all appliances including metal, ceramic and plastic are indicated. This single paste bonding adhesive has a blue 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. D3 Chroma has very fast light cure properties and achieves high strength allowing active archwires to be placed immediately. D3 Chroma is compatible with traditional etching and sealant procedures, as well as newer self-etching techniques.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) summary for the D3 Chroma orthodontic adhesive, primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and claims substantial equivalence, but it does not include:

1. A table of acceptance criteria and reported device performance: While it mentions properties like "fast light cure" and "high strength," no specific quantitative acceptance criteria or detailed performance data are presented.
2. Sample size used for the test set and data provenance: No information about a test set or its sample size is provided.
3. Number of experts used to establish ground truth and their qualifications: Ground truth establishment is not discussed.
4. Adjudication method: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study is described. This device is an adhesive, not an AI-assisted diagnostic tool.
6. Standalone (algorithm only) performance: Not applicable as it's an adhesive, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable for this type of device.
9. How ground truth for the training set was established: Not applicable.

The document is a regulatory submission for a physical medical device (orthodontic adhesive) and not a study on an AI/ML-based diagnostic or prognostic device that would typically involve the kind of information you are asking for (e.g., ground truth, expert consensus, training/test sets, MRMC studies).

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