(99 days)
The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.
Clear Moves Aligners are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.
This document is a 510(k) Premarket Notification from the FDA for a dental device called "Clear Moves Aligners." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials. Therefore, the information provided focuses on comparisons to existing devices and bench testing, rather than detailed human clinical study data with specific acceptance criteria, expert ground truth, or MRMC studies that would be typical for more novel or higher-risk medical devices.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device itself (e.g., accuracy of tooth movement in millimeters). Instead, the "performance" described is about demonstrating that the manufacturing process is valid and the materials are biocompatible, and that the device is "substantially equivalent" to predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence and Safety) | Reported Device Performance (from the document) |
|---|---|
| Biocompatibility: Device materials must be biocompatible. | Biocompatibility: "Testing of the plastic thermoformable materials used to make these aligners have been provided in previous 510(k) submissions to FDA. The Reference 510(k) is included because it was submitted for the copolyester material to be used for fabrication of many oral appliances using thermoforming processes." "Yes, shown to meet requirements" in the SE Comparison Table. |
| Manufacturing Process Validation: The manufacturing process must ensure accuracy of the final thermoformed aligner compared to the initial digital scan. | Manufacturing Process Validation: "Bench testing was performed of each aligner thermoplastic material to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan. A final report was part of the 510(k) package." "Yes, performed" in the SE Comparison Table. |
| Equivalence in Intended Use: The device must have the same intended use as the predicate devices. | Equivalence in Intended Use: "The Clear Moves Aligner has the same intended use as the predicate devices." (Confirmed in Indications for Use vs. Predicates table). |
| Equivalence in Material: The thermoplastic materials used must be the same as or comparable to those in predicate devices. | Equivalence in Material: "The thermoplastic materials used for the manufacture of the Clear Moves Aligers are the same materials used to make the predicate aligners." (Detailed in Material row of SE Comparison Table). |
| Equivalence in Design/Technology: The design phase and software used must be the same as or comparable to those in predicate devices. | Equivalence in Design/Technology: "The design phase makes the use of the same software as the Predicates." "The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (Reference device - K180941). It also is the same as used for the Predicates." |
| Equivalence in Manufacturing Fabrication: The manufacturing fabrication process must be similar to industry-standard processes used for predicate devices. | Equivalence in Manufacturing Fabrication: "The manufacturing fabrication of the clear aligner makes use of similar, industry-standard processes with the similar machines and materials. Any differences in the specific company processes do not raise new questions of safety and effectiveness." (Detailed in Manufacturing Process row of SE Comparison Table). |
2. Sample sizes used for the test set and the data provenance
The document explicitly states: "In vivo Animal and Human Clinical performance testing are not required for this device category." Therefore, there is no test set of clinical patient data in the traditional sense, for which sample sizes or data provenance (country, retrospective/prospective) would be applicable concerning the device's clinical performance. The "test sets" mentioned would be for biocompatibility testing (material samples) and mechanical bench testing (prototype aligners/molds). These details are not provided in terms of specific sample numbers or origins within this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no human clinical performance testing was required or conducted for this 510(k) submission, there was no "ground truth" derived from expert consensus on patient outcomes/diagnoses related to the device's effectiveness. Ground truth for bench testing would typically involve engineering specifications or physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical orthodontic aligner, not an AI-powered diagnostic or assistive tool. While software is used for treatment planning, the submission focuses on the aligner itself and does not include an MRMC study comparing human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm being submitted for standalone performance. The software mentioned (Ortho Analyzer) is a pre-existing, referenced device used for treatment planning, not for autonomous diagnosis or treatment execution.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the compliance requirements:
- Biocompatibility: Ground truth would be established by validated test methods (e.g., ISO standards) and comparison to known safe materials.
- Manufacturing Process Validation: Ground truth would be established by engineering specifications, CAD models, and precise measurements comparing the manufactured parts to the digital design.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set" for an algorithm to learn from data.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI algorithm was used.
§ 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.