Search Results
Found 1 results
510(k) Data Aggregation
(300 days)
The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.
SunClear Aligners consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. SunClear Aligners are intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary software generates the final image of a treated state and then interpolates a series of images that represent the intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SunClear Aligner system:
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about a novel performance study with acceptance criteria. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert qualifications, and specific effect sizes for AI assistance or standalone performance is not present in the provided text.
The primary "study" described here is a bench test comparing flexural strength. The acceptance criteria are essentially met by demonstrating similarity to the predicate device and the use of previously cleared materials.
Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria
The SunClear Aligner system's acceptance criteria are centered on demonstrating substantial equivalence to existing legally marketed devices, specifically the K172765 - Smart Moves Complete aligner system and, for software technology, K150702 - eXceed Computerized Precision Bracket Placement Solution. The device's performance is primarily evaluated through a non-clinical bench test on flexural strength and by verifying the use of materials previously cleared for similar intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Indications for Use | Similar to predicate device (K172765). Indicated for the treatment of tooth malocclusion in patients with permanent dentition (all second molars) by positions teeth via continuous gentle force. The software utilized must be identical to that cleared under K150702 and K172765. | "The Indications for Use are similar to predicate - K172765 - Smart Moves Complete." The software is "identical to what was cleared under K150702 and K172765." |
| Technology and Construction | Similar to predicate device (K172765). Aligners manufactured the same as the predicate, including identical materials. | "The technology and construction are similar to predicate - K172765 - Smart Moves Complete." "The software is identical, and the aligners are manufactured the same as the predicate including the identical materials." |
| Environment of Use | Similar to predicate (K172765) and reference (K150702). Home use. | "The environments of use are similar to predicate - K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution." "The environment is similar to predicate and reference, namely - home use." |
| Patient Population | Similar to predicate (K172765) and reference (K150702). Patients needing treatment of tooth malocclusion. | "The patient population is similar to predicate K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution." "The patient population is similar to the predicate - K172765 - Smart Moves Complete." |
| Biocompatibility | Aligner material identical to K062828 - Dentsply International Aligner materials, which has similar intended use and patient contact, thus eliminating need for new testing. | "No testing was performed as the material of the aligners is identical to the K062828 - Dentsply International - Aligner materials which has similar intended use and patient contact." |
| Performance (Bench Testing) | Flexural Strength: Demonstrate comparable flexural strength to the predicate materials. The aligner material used must have been previously cleared under K062828 for the intended use. The objective is to show that the SunClear Aligners, made of similar material, perform comparably. No specific quantitative criteria are provided but the implication is "non-inferiority" or "comparability" to the predicate/cleared material. | "SunClear Aligners are made of similar aligner material as the predicate. The identified aligner material has been cleared under K06282 for the intended use. We have performed flexural strength of the subject device and predicate materials." (Conclusion: "The sponsor has demonstrated through performance testing... that the proposed device and predicate have been found to substantially equivalent.") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the flexural strength bench testing. The testing was performed on "the subject device and predicate materials," implying a sample of aligner materials.
- Data Provenance: The flexural strength testing would have been conducted in a lab environment. No information on country of origin for this specific test, nor if it was retrospective or prospective, is provided, as it is a bench test on materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this 510(k) summary. The primary evaluation involved material properties (flexural strength) and comparison to predicate device specifications, not expert-based ground truth for clinical outcomes or diagnoses.
4. Adjudication Method for the Test Set
Not applicable. The flexural strength testing would involve objective measurements, not subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance for human readers. This device is an orthodontic aligner system, not an AI-powered diagnostic or assistive tool in the context of human reading of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device includes proprietary 3-D software, the summary does not describe a standalone performance study of the software as a diagnostic or analytical algorithm without human-in-the-loop. The software's role is described as generating images for dental practitioners to review, edit, and approve, implying human supervision. The software itself is considered "identical" to a previously cleared system (K150702), indicating that its performance was likely evaluated as part of that prior submission.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth is established by prior clearance of identical materials (K062828 - Dentsply International Aligner Material) for similar intended use and patient contact.
For flexural strength, the ground truth is established by objective measurements being comparable to the predicate device's materials.
There is no "expert consensus, pathology, or outcomes data" ground truth described in this 510(k) summary for the device's performance, as the emphasis is on material equivalence and functional similarity to predicates.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (aligner system with associated software), not a machine learning model developed with a dedicated training set. The software is stated to be "identical" to previously cleared software, implying its development and validation occurred prior to this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a dedicated training set for a novel machine learning algorithm in this 510(k) summary.
Ask a specific question about this device
Page 1 of 1