(166 days)
The Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.
Align Technology Inc. (Align) has developed the Align System, which is a series of clear plastic appliances (Aligners) that are intended to replace conventional wire and bracket technology for many orthodontic cases. The series of Aligners moves the patient's teeth in small increments from their original state to a final, treated state. The Align System will use a computer as a tool to assist in creating a series of Aligners that represent sequential movements to generate light and consistent forces on the patient's teeth.
A Dental Practitioner using the Align System diagnoses a patient, determines a treatment plan, and makes dental stone models of a patient's teeth. The Dental Practitioner then sends the molds, along with a prescription for treatment to Align. Align uses three-dimensional laser scanning technology to scan the mold into a computer. From this scanned image (which represents an untreated state) and following the Dental Practitioner's prescription, Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. For each of these intermediate states, a rapid prototyping machine (such as a stereolithography machine) produces corresponding dental molds. In the final step, Align uses a conventional air pressure device (e.g., a Biostar) and commercially available retainer or positioner material (made by Raintree Essix or equivalent) to craft plastic Aligners to fit the developed teeth molds. The models with their corresponding Aligners are then mailed back to the Dental Practitioner. The total number of Aligners can vary from 1 to over 100 per patient, depending on the complexity of the case. The Aligners are individually identified and are dispensed to the patient by the Clinician with specific instructions for use (i.e., the Aligners are to be worn in a prescribed sequence).
This document is a 510(k) premarket notification for the "Align System" (later known as Invisalign). It describes the device and claims substantial equivalence to existing predicate devices. However, it does not provide a study to prove the device meets specific acceptance criteria in the way you've outlined.
Here's a breakdown based on the provided text, highlighting what's missing and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothetical) | Reported Device Performance (as stated in document) |
|---|---|
| (Not explicitly defined in the document) | "The Align System positions teeth by way of continuous gentle force." |
| (Not explicitly defined in the document) | "The Aligners are equivalent to the currently marketed predicate devices." |
| (Not explicitly defined in the document) | "Sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness." |
Explanation: The document is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing and meeting novel performance acceptance criteria through clinical trials. Therefore, explicit, quantified acceptance criteria and specific performance metrics designed to meet them are not present in this filing.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No "test set" in the context of controlled clinical efficacy studies is described.
- Data Provenance: Not applicable. The submission relies on the concept of substantial equivalence, stating that "sufficient information available from the scientific literature" supports the safety and effectiveness of preformed tooth positioners in general. There is no specific original test data presented in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No test set requiring expert ground truth establishment is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
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
- MRMC Study: No. This device is a physical orthodontic appliance, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant here.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. While the Align System "will use a computer as a tool to assist in creating a series of Aligners," the device itself is the physical aligner, and its performance is assessed by its ability to move teeth, not as a standalone diagnostic algorithm. The computer is described as a "tool to assist" in the design process, not as a standalone diagnostic or treatment algorithm.
7. The type of ground truth used
- No specific ground truth data for a novel study is presented. The "ground truth" implicitly relies on:
- The known mechanisms of action for orthodontic forces.
- The established clinical effectiveness of predicate preformed tooth positioners.
- The "Dental Practitioner's prescription" which guides the desired final state of the teeth.
- The "scientific literature" mentioned for general assurance of safety and effectiveness of the device type.
8. The sample size for the training set
- Sample Size: Not applicable. The document does not describe a "training set" in the context of machine learning or AI development for the device's performance evaluation. The "Align System" itself is the series of physical aligners. While their software generates images, there's no mention of a training set for an AI model that diagnoses or predicts treatment outcomes in a general sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. No training set is described.
Summary of Device and Evidence Presented:
This 510(k) submission for the Align System (Aligners) describes a series of clear plastic appliances intended to treat malocclusion. The key to its regulatory clearance is the claim of substantial equivalence to existing, legally marketed preformed tooth positioners (e.g., those from Great Lakes Orthodontics, TP Orthodontics, and Ortho-Tain).
The evidence provided to support this claim focuses on:
- Technological Characteristics: Stating that "The Aligners are equivalent to the currently marketed predicate devices."
- Intended Use: The Align System's intended use ("treatment of tooth malocclusion in patients with permanent dentition...positions teeth by way of continuous gentle force") is aligned with that of predicate devices.
- Performance Data: The document explicitly states: "Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."
In essence, the "study" proving the device meets criteria is the argument for substantial equivalence, relying on the established history and scientific understanding of its predicate devices, rather than new, primary clinical or bench studies for this specific product.
§ 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.