(227 days)
Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion. The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
This FDA 510(k) summary focuses on demonstrating substantial equivalence of the "Angel Align System" to a predicate device (Invisalign - K143630), rather than a study proving the device meets acceptance criteria in the way a de novo or PMA would. Therefore, much of the requested information regarding specific acceptance criteria and detailed study designs for performance is not explicitly provided in this document.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not defined in this 510(k) summary (which is typical for a substantial equivalence claim for a physical device like aligners), this table will describe the types of tests performed and their outcomes in relation to establishing equivalence.
| Acceptance Criteria Category | Reported Device Performance (Angel Align System) |
|---|---|
| Intended Use | Same as predicate (alignment of teeth during orthodontic treatment of malocclusion). |
| 3-D Software Description | Same as predicate (uses scan to generate treated models, allows practitioner review/modification, converts files for aligner production). |
| Mode of Operation for 3-D Software | Same as predicate (produces 3D-model, identifies teeth for treatment, creates treatment plan, allows practitioner review/modification). |
| Material | Primarily uses 0.03" thick, thermoformed polyurethane. (Predicate uses this OR multilayer aromatic thermoplastic polyurethane/copolyester). This minor difference was deemed not to impact safety or efficacy. |
| Mode of Use | Same as predicate (each appliance worn for ~2 weeks. |
| Description of Appliance Application | Same as predicate (removable). |
| Manufacturing Method | Same as predicate (digital model from scan/PVS impression, software generates treated states, rapid prototyping for physical models, thermoforming to produce aligners). |
| Software Validation | PASS |
| Design Verification and Validation | PASS |
| ISO 10993 (Biocompatibility) | PASS |
| Clinical Performance (Post-Market Study) | PASS (provides evidence of safety and effectiveness for all tooth movements and demonstrates substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for specific non-clinical or clinical studies. The document only mentions "non-clinical performance tests" and "post market clinical data".
- Data Provenance: Not explicitly stated (e.g., country of origin). The clinical data is referred to as "post market clinical data," implying it would be collected after the predicate device was on the market and potentially includes data from various regions where the predicate was used. It is retrospective in the sense that data from an already marketed device (the predicate, or market data related to similar aligner use) was likely utilized to support the equivalence claim, but the specific nature of the clinical "study" is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For a 510(k) for a physical orthodontic aligner device, direct human expert ground truth establishment for a test set as one might see in an AI/imaging device is not typically detailed in this manner. The "ground truth" here is implied by the established orthodontic principles and the clinical outcomes observed in patients treated with similar devices.
4. Adjudication Method for the Test Set
- This information is not provided and is generally not applicable to this type of device and submission. Adjudication methods are more common in clinical trials evaluating specific endpoints with subjective interpretation, particularly relevant for AI/imaging device performance assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of this 510(k). The Angel Align System is a physical orthodontic aligner, and its accompanying software is for treatment planning and aligner design, not a diagnostic AI tool that would assist human "readers" (like radiologists interpreting images). Therefore, the concept of "human readers improve with AI" does not directly apply here. The software is a tool for the dental practitioner, not an interpretative aid that independently makes diagnoses requiring reader performance comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The 3D software component of the Angel Align System generates a provisional treated state and a series of intermediate teeth states, but it explicitly states: "The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication."
- This indicates that the software is not standalone in its clinical application; it operates with a human-in-the-loop (the dental practitioner) who reviews and approves the outputs before aligner fabrication. Therefore, a standalone performance study in the context of a fully autonomous AI system was not described or performed as the device requires human interaction and approval.
7. The Type of Ground Truth Used
- For the technical and performance characteristics, the "ground truth" is established by engineering and material science standards (ISO10993, software validation, design verification) relative to the predicate device.
- For clinical performance, the "ground truth" is based on clinical outcomes data from a "post market clinical study" which demonstrated safety and effectiveness for tooth movements, inferring successful orthodontic corrections in patients. This aligns with the accepted clinical efficacy for clear aligner systems.
8. The Sample Size for the Training Set
- This information is not provided. The software generates treatment plans based on a scan of the patient's teeth and likely relies on algorithms and biomechanical models, not necessarily a "training set" in the machine learning sense that would require a quantified sample size for training. If the software utilizes any machine learning component (which is not explicitly detailed but is common in 3D modeling), the training data details are not disclosed.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided as a "training set" in the typical AI sense is not explicitly mentioned with its ground truth establishment in this document. The software functions based on established principles of orthodontics and 3D modeling, with human oversight for approval.
§ 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.