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Cyanoacrylate adhesive
The provided text is a 510(k) summary for a medical device called "Gridlock 195," an orthodontic adhesive. It contains administrative details, classification information, and a comparison to a predicate device ("SmartBond" bonding agent K981036). However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.
It merely states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This type of submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy or performance study data with specific acceptance criteria as might be seen in a PMA (Premarket Approval) application or a clinical trial report.
Therefore, I cannot provide the requested information based on the given text.
No information regarding acceptance criteria, device performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is present in the provided 510(k) summary.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.