(3 days)
A light cure orthodontic band cement intended to bond orthodontic bands to teeth.
American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth.
When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.
The provided document describes the 510(k) submission for "BracePaste Band and Build LC," an orthodontic band cement. The document states that no clinical performance testing has been conducted. The submission relies on non-clinical performance testing and a comparison to a predicate device to establish substantial equivalence.
Therefore, the following information regarding acceptance criteria, study details, and ground truth cannot be extracted as they are not present in the provided text.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable (no clinical testing).
- Data Provenance: Not applicable (no clinical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (no clinical testing).
4. Adjudication method for the test set:
- Not applicable (no clinical testing).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is an orthodontic band cement, not an AI device for diagnostic reading.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI algorithm.
7. The type of ground truth used:
- Not applicable (no clinical testing). For non-clinical testing, relevant benchmarks were likely derived from material science standards.
8. The sample size for the training set:
- Not applicable (no machine learning model to train).
9. How the ground truth for the training set was established:
- Not applicable (no machine learning model to train).
Non-Clinical Performance Testing Details (as provided):
The document states that the following non-clinical performance tests were conducted:
- Shear Bond Strength Test (ISO 29022:2013)
- Accelerated Aging Stability Test
- Interaction with Accessories
The conclusion states that the "combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy or suitability to the intended purpose of the BracePaste Band and Build LC." It also states, "Results of bench testing indicate that BracePaste Band and Build LC performs as well as the predicate Light-Cured Orthodontic Band Cement." However, specific numerical acceptance criteria or reported performance values for these tests are not provided in the document.
§ 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.