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510(k) Data Aggregation
(13 days)
Eon Aligner
Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions teeth by way of continuous gentle force.
The Eon Aligners is a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as alternative traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.
The Eon Aligner device is an orthodontic plastic bracket used for the treatment of tooth malocclusion in patients with permanent dentition. The provided text outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826).
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance metrics typically found in AI/ML performance studies (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are based on demonstrating equivalence in materials, manufacturing processes, intended use, operating principles, and biocompatibility.
| Acceptance Criteria Category | Reported Device Performance (Eon Aligner) |
|---|---|
| Intended Use | Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions teeth by way of continuous gentle force. This is identical to the predicate device. |
| Mechanism of Action | Orthodontic movement occurs by means of gentle forces applied on the teeth by the aligner, following a programmed movement approved by the dental health professional. This is identical to the predicate device. |
| Patient Population | Patients with all permanent dentition. This is identical to the predicate device. |
| Materials Used | Polyurethane-polyester copolymer resin. This is identical to the predicate device. |
| Sterility | Not supplied sterile. This is identical to the predicate device. |
| Wear at Night | Yes. This is identical to the predicate device. |
| Dental Health Professional Review | A dental health professional takes patient impressions/scans, sends them to the dental lab, reviews the treatment setup, and can reject or modify it before approval. Final aligners are dispensed by the dentist/orthodontist who monitors the patient's orthodontic movement. This workflow is described as similar to the predicate. |
| Biocompatibility | Passed all 11 listed biocompatibility tests (Cytotoxicity, Maximization Test for delayed-type hypersensitivity, Intracutaneous Reactivity Test, Oral Mucosal Irritation Test, Bacterial reverse mutation assay, In vitro mammalian cell TK gene mutation test, Skin irritation study, Skin sensitization test, Tests for systemic toxicity/Subchronic systemic toxicity test, In vitro mammalian chromosome aberration test). The device materials are identical to the predicate, and these tests confirm no adverse biological effects. |
| Manufacturing Workflow Validation | A manufacturing fit validation study in two parts: 1) established steps for aligners from manual impressions and digital scans. 2) Recreated 3D printed models and aligners from eight patients with successful malocclusion treatment. Results demonstrated minimal differences between digital inputs and final aligners, validating the workflow. |
2. Sample Size Used for the Test Set and Data Provenance
The manufacturing fit validation study used a sample size of eight (8) patients who had successfully undergone malocclusion treatment. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text. It is assumed to be retrospective as it involved re-creating models from "successfully undergone malocclusion treatment."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text does not explicitly state the number of experts or their qualifications for establishing the ground truth for the manufacturing fit validation study. The study involved recreating 3D printed models and aligners based on "successful treatment," implying that the "ground truth" was the outcome of successful treatment as prescribed and achieved by a dentist/orthodontist. The process involves a "prescribing physician" reviewing and approving the treatment setup, suggesting ongoing expert involvement, but not a specific ground truth adjudication panel for the manufacturing validation.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method (e.g., 2+1, 3+1) in the context of an expert review panel for the manufacturing fit validation study. The standard for "ground truth" in this context appears to be the successful outcome of malocclusion treatment for the eight patients. The validation aimed to show that the manufacturing process could accurately reproduce the digital plan, with differences being "minimal."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device submission. The Eon Aligner is a physical medical device (orthodontic plastic bracket), not an AI-assisted diagnostic or therapeutic tool for which human-reader performance would be evaluated. The submission focuses on demonstrating the physical and functional equivalence of the device to an existing predicate.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for an algorithm was not performed, as the Eon Aligner is a physical medical device. While the device relies on "dental software intended for tooth alignment" for its design, the submission focuses on the manufactured product and its biological interaction, not the performance of the software itself as a standalone diagnostic tool. The manufacturing workflow validation included aspects of the "design software" and "3D-Printing," validating the process of creating the aligners, not the interpretative accuracy of the algorithm.
7. Type of Ground Truth Used
For the manufacturing fit validation study: The ground truth was based on the successful outcome of malocclusion treatment in eight (retrospective) patients, where the 3D printed models and aligners were recreated to demonstrate that the manufacturing process could achieve the intended therapeutic outcome with minimal deviation from the digital plan.
For biocompatibility: The ground truth was established by standardized laboratory tests per ISO 10993 series and confirmed against the identical materials of the predicate device.
8. Sample Size for the Training Set
The text does not mention a training set in the context of an AI/ML algorithm. The "training" for this device would relate to the manufacturing validation and biocompatibility, not an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an algorithm training set, this question is not applicable. The ground truth for the manufacturing validation was indirectly established by the successful treatment outcomes of previously treated patients. The "prescribing physician reviews and approves the treatment setup before the plastic trays are produced," implying that the clinician's approval of the treatment plan serves as the internal 'ground truth' for the design stage.
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