(26 days)
The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
The provided submission focuses on the substantial equivalence of the BioMers Translucent Orthodontic Bracket to predicate devices, primarily through comparison of technical characteristics and existing standards for dental materials. It does not contain information typically found in an AI/ML device submission regarding acceptance criteria for algorithm performance or detailed study designs for proving such criteria.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text as they pertain to AI/ML device testing methodologies not present here.
However, I can extract the acceptance criteria and performance data related to the device's material properties, which are relevant to its substantial equivalence claim.
Here's the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission uses "Bond Strength" as a key performance metric for the BioMers Translucent Orthodontic Bracket, tested according to ISO 11405-2003(E). While explicit "acceptance criteria" in terms of a minimum or range for bond strength are not directly stated as a pass/fail threshold, the device's performance is compared against its predicates. The implication is that performance comparable to or better than predicate devices, within a clinically acceptable range, demonstrates safety and effectiveness.
| Performance Metric | BioMers Translucent Orthodontic Bracket Performance (Mean ± SD) | Predicate 1: Absolute (Star Dentech Korea) Performance (Mean ± SD) | Predicate 2: PURE Sapphire (Ortho Technology) Performance (Mean ± SD) |
|---|---|---|---|
| Bond Strength | 11.73 ± 3.04 | 5.51 ± 1.65 | 19.41 ± 5.08 |
Note: Units for bond strength are not explicitly stated in the table but are typically in MPa for this type of test.
Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):
The study primarily supporting the device's claims is a bench test and functional testing study conducted according to ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure. This standard guides the methodology for evaluating the bond strength of dental materials to tooth structure.
Key Findings from the "Study":
- The BioMers Translucent Orthodontic Bracket demonstrated a bond strength of 11.73 ± 3.04 (units not specified, but likely MPa).
- This performance falls within the range observed for the predicate devices, being higher than one predicate (Absolute: 5.51 ± 1.65) though lower than the other (PURE Sapphire: 19.41 ± 5.08). The submission implicitly argues that this performance, combined with similar technological characteristics and adherence to safety standards (ISO 10993 for biocompatibility, ISO 14971 for risk analysis), establishes substantial equivalence.
Regarding AI/ML-specific questions (2-9):
The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert review, sample sizes for AI/ML models, or MRMC studies. The device in question is a physical orthodontic bracket, and the submission focuses on its material properties and comparison to existing physical devices, not an AI/ML algorithm. Therefore, the following sections cannot be populated:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.