(2 days)
3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The 3M Clarity Aligners, 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The present Premarket Submission is for the addition of a new form of the aligner called 3M Clarity Aligners-Flex to the 3M Clarity Aligner system. 3M will continue to offer aligners composed of the same material as previously cleared (K192119) as 3M Clarity Aligners-Force. 3M will offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.
A dental health professional (e.g. orthodontist or dentist), prescribes 3M Clarity Aligners, 3M Clarity-Flex, 3M Clarity Aligners-Force based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
This document outlines the acceptance criteria and the study proving the device meets these criteria for the 3M™ Clarity™ Aligners (Force and Flex), based on the provided FDA 510(k) submission summary.
Executive Summary:
The 3M™ Clarity™ Aligners-Flex device is being introduced as an addition to the already cleared 3M™ Clarity™ Aligner system (predicate device K192119). The primary difference is the introduction of a new material, "3M Flex Thermoplastic Material", alongside the existing "3M Force Thermoplastic Material". The submission argues for substantial equivalence by demonstrating that the new material and combination treatment plans do not alter the fundamental indications for use, manufacturing processes, design, or device features as compared to the predicate device. Performance testing confirms acceptable results for optical properties, mechanical stability, staining, transportation, use life, force, and conditioning. Biocompatibility testing was also conducted and found the product safe for its intended use.
Acceptance Criteria and Device Performance Study
The provided 510(k) summary does not detail explicit quantitative acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or AUC that would typically be associated with AI/ML diagnostic or prognostic devices. Instead, the acceptance criteria appear to be qualitative and relate to demonstrating that the new 3M™ Clarity™ Aligners-Flex are substantially equivalent to the predicate device (3M™ Clarity™ Aligners, K192119) across various performance aspects, particularly concerning its physical and material properties, and its continued safety and efficacy for its stated indications.
The "study" in this context refers to the performance testing conducted to support the substantial equivalence claim, rather than a clinical trial comparing the diagnostic accuracy of an AI system.
Here's an interpretation of the acceptance criteria and reported performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | Must align with the predicate device (alignment of teeth during orthodontic treatment of malocclusion). | "Clarity Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion." (Identical to predicate). The addition of 3M Clarity Aligners-Flex and combination treatment plans maintains this indication. |
| Manufacturing Process | Must be consistent with or equally robust as the predicate device's automated state-of-the-art process. | "No change" compared to the predicate device's manufacturing process. |
| Device Design/Features | Must maintain the same design and device features as the predicate device. | "3M Clarity Aligners-Flex and the previously cleared 3M Clarity Aligners (K192119) have the same design, device features, software as well as their manufacturing processes." Also, "Orthodontic tooth movements occur through forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription" (No change). |
| Software | Must be unchanged from the predicate device's proprietary manufacturing software. | "There are no changes in the software compared to the existing 3M Clarity Aligners (K192119)." |
| Optical Properties | Must meet predefined standards for clarity, transparency, or other relevant optical attributes for clear aligners. | "Results of optical properties... are included in this Premarket submission which showed acceptable results for all tested samples." |
| Mechanical Stability | Must demonstrate sufficient strength, durability, and resistance to deformation under typical use conditions. | "Results of... mechanical stability... are included in this Premarket submission which showed acceptable results for all tested samples." |
| Staining Resistance | Must resist common staining agents encountered during oral use to maintain aesthetic appearance. | "Results of... staining... are included in this Premarket submission which showed acceptable results for all tested samples." |
| Transportation Stability | Must withstand typical shipping and handling conditions without degradation. | "Results of... transportation... are included in this Premarket submission which showed acceptable results for all tested samples." |
| Use Life (Durability) | Must maintain performance and integrity throughout the prescribed wear period. | "Results of... use life... are included in this Premarket submission which showed acceptable results for all tested samples." |
| Force Application | Must consistently apply forces necessary for programmed tooth movement, comparable to the predicate device. | "Results of... force... are included in this Premarket submission which showed acceptable results for all tested samples." While the material is different, the "Technical Features and Properties" section states "No change" implying similar force application principles. |
| Conditioning | Must retain properties after exposure to environmental conditions (e.g., temperature, humidity) throughout its lifecycle. | "Results of... conditioning among others are included in this Premarket submission which showed acceptable results for all tested samples." |
| Biocompatibility | Must be safe for mucosal membrane contact for greater than 30 days, adhering to relevant FDA guidelines. | "The biocompatibility evaluation for the device was conducted in accordance with US FDA Docket Number FDA-2013-D-0350 edition dated: September 4, 2020. The aligner is considered mucosal membrane contacting device that is intended to be in contact with the body for greater than 30 days. The evaluation found this product to be safe for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "acceptable results for all tested samples" for the performance testing (optical properties, mechanical stability, etc.). However, it does not specify the exact number of samples used for each test.
- Data Provenance: The document does not specify the country of origin of the data. It's implicitly retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency, but it's not a clinical study on patients. The data is derived from laboratory and material testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not applicable to this submission. The "ground truth" here is not based on expert clinical consensus or interpretation of medical images/data, but rather on direct physical and material property measurements and biocompatibility testing against established standards. The device is a physical orthodontics product, not an AI diagnostic tool requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
- This is not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations, as the testing involves objective physical measurements and adherence to material standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- This is not applicable. The device is an orthodontic aligner, not an AI diagnostic or assistive tool. Therefore, no MRMC study, AI assistance, or human reader improvement effect size is relevant to this submission.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- This is not applicable. This describes a physical medical device (orthodontic aligner) and not an AI algorithm. While it leverages proprietary CAD/CAM software in its manufacturing, the submission does not present performance data for the software in a standalone "algorithm only" context, as the software's performance is intrinsically linked to the physical output of the aligners.
7. The Type of Ground Truth Used
- The "ground truth" for this device is based on objective physical and chemical properties measurements, engineering specifications, and established biocompatibility standards. It's not clinical outcomes data, pathology, or expert consensus in a diagnostic sense. The ground truth for the "acceptability" of these measurements is predefined by internal company specifications and relevant industry/regulatory standards (e.g., ISO standards for plastics, FDA guidance for biocompatibility).
8. The Sample Size for the Training Set
- This is not applicable. The device is a manufactured physical product. There is no "training set" in the context of machine learning or AI algorithm development. The manufacturing processes are established through engineering design, material science, and quality control, not data training.
9. How the Ground Truth for the Training Set was Established
- This is not applicable for the same reason as point 8.
§ 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.