(9 days)
An orthodontic archwire used to provide force to the teeth to effect movement in orthodontic treatment.
The SimpliClear Rectangular Orthodontic Wire is a translucent archwire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases the abrasion resistance properties of the wire.
Here's a breakdown of the acceptance criteria and the study details for the SimpliClear Rectangular Orthodontic Wire, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Predicate Device Range (ORMCO NiTi & beta-Ti, BioMers Translucent Orthodontic Wire) | SimpliClear Rectangular Orthodontic Wire Performance (relative to predicate) |
|---|---|---|---|
| Material Properties | Elastic Modulus (tendency to be deformed elastically) Tested per ASTM D3916-02. | Established range (ORMCO NiTi & beta-Ti, BioMers Translucent Orthodontic Wire) | Greater than the established range. However, the document states: "do not raise safety or effectiveness issues as compared to the predicate devices" as higher values indicate a better ability to deform under load and recover to original state. |
| Tensile Strength (maximum stress withstandable when stretched) Tested per ASTM D3916-02. | Established range (ORMCO NiTi & beta-Ti, BioMers Translucent Orthodontic Wire) | Within the established range. | |
| Flexural Strength (ability to resist deformation under load) Tested per ASTM D790-03. | Established range (ORMCO NiTi & beta-Ti) | Within the established range. | |
| Flexural Modulus (ratio of stress to strain in flexural deformation, tendency to bend) Tested per ASTM D790-03. | Established range (ORMCO NiTi & beta-Ti) | Within the established range. | |
| Biocompatibility | Meets applicable requirements of ISO10993 | Meets ISO10993 | Meets the applicable requirements of ISO10993. |
| Intended Use | As an orthodontic archwire to provide force to the teeth to effect movement in orthodontic treatment (SimpliClear) / As an orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment (BioMers Translucent Orthodontic Wire) / Orthodontic arch wire (ORMCO) | Comparable | Intent for the SimpliClear Rectangular Orthodontic Wire is comparable to the predicate devices. "any differences in technological characteristics do not raise issues of safety and effectiveness." |
| Composition | Glass fibers with a polymer composite resin, and a polymer coating | BioMers Translucent Orthodontic Wire: Glass fibers with a polymer composite resin, and a polymer coating; ORMCO: Nickel Titanium, beta-Titanium and Stainless Steel | Substantially equivalent in terms of composition to the BioMers Translucent Orthodontic Wire. While different from Ormco (metal vs. polymer composite), substantial equivalence is claimed based on comparable mechanical properties and no new safety/effectiveness issues arising from the differences. |
2. Sample Size and Data Provenance for the Test Set
The document does not specify a separate "test set" in the context of clinical data for algorithmic performance. Instead, the "testing" described is bench testing of physical properties of the orthodontic wires.
- Sample Size for Bench Testing: Not explicitly stated in terms of the number of wires or samples tested for each metric (Elastic Modulus, Tensile Strength, Flexural Strength, Flexural Modulus). The text indicates "At similar wire dimensions" for comparisons, implying various dimensions were tested.
- Data Provenance: The data comes from in-vitro bench testing performed according to specific ASTM standards (ASTM D3916-02 and ASTM D790-03). This is therefore not patient data, nor is it retrospective or prospective in the clinical sense.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
Not applicable. The ground truth for the "test set" (bench testing) is derived from objective physical measurements and adherence to recognized ASTM standards, not expert consensus on clinical findings.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "test set" consists of physical property measurements against established ASTM standards, not interpretive data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the substantial equivalence of a physical medical device (orthodontic wire) based on its material composition and mechanical properties, compared to predicate devices. It does not involve AI or human readers evaluating cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an AI/algorithm-based device.
7. Type of Ground Truth Used
The ground truth for the device's performance is based on objective physical measurements obtained through standardized laboratory tests (ASTM D3916-02 for Elastic Modulus and Tensile Strength, ASTM D790-03 for Flexural Strength and Flexural Modulus) and compliance with biocompatibility standards (ISO10993). Comparisons are then made to the performance ranges of legally marketed predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.