(17 days)
The orthodontic adhesive is used to bond dental orthodontic brackets onto a tooth or teeth where a filled, light-cure (light-activated) resin-adhesive is indicated. This type of cure is used when sufficient light exposure is possible due to the low opacity of the bracket or through excessive use of adhesive the adhesive can be directly exposed to light.
The orthodontic adhesive can also be used to bond orthodonticbands in place where a filled light-cure resin-adhesive is indicated (sufficient light exposure is possible to cure/harden/polymerize the adhesive).
The adhesive can also be used to bond or cement a non-opaque dental restoration (crown, bridge, vencer, inlay,only, etc.) to the tooth when the material of the restoration permits sufficient light through it to cure/harden/polymerize the adhesive. It is not indicated when radiopacity is needed in the adlesive.
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The provided document is a 510(k) clearance letter from the FDA for the "Aegis® ORTHO Light-Cured Orthodontic Adhesive." This type of document declares "substantial equivalence" to a predicate device, which means the new device is as safe and effective as a legally marketed device that does not require premarket approval.
It is important to understand that this document does NOT contain a detailed description of acceptance criteria or a study proving the device meets those criteria in the way you've outlined for a typical AI/software medical device submission.
This document is for a physical dental adhesive, not an AI or software device. Therefore, the specific questions you've asked regarding AI device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth definitions are not applicable to the content of this 510(k) letter.
The FDA's review for this type of device primarily relies on:
- Comparison to a predicate device: Showing that the new device has the same intended use, technological characteristics, and performs as well as a device already on the market.
- Performance testing: This would involve bench testing (e.g., bond strength, wear, solubility, biocompatibility) to demonstrate that the device meets an accepted standard or performs comparably to the predicate. Details of these tests are not included in this summary letter.
Therefore, I cannot populate your requested table and information points based on the provided text. The document does not contain the information requested.
§ 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.