Search Results
Found 1 results
510(k) Data Aggregation
(122 days)
The Carriere SLX 3D Clear orthodontic ceramic bracket system is in the movement of teeth during orthodontic treatment.
The Carriere SLX 3D Clear is a ceramic passive self-ligating orthodontic bracket system that directly bonds to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. Each bracket is comprised of four individual components; a polycrystalline alumina door, a polycrystalline alumina base, and two 304 stainless steel springs. The two springs are laser welded together and borne by the springs are the force giving mechanism in the bracket system, providing tactile and audible feedback for the clinician when opening and closing the door. The springs also provide a mechanism to keep all four components assembled throughout treatment. Because the Carriere SLX 3D Clear is a passive self-ligating bracket system, wherein the door portion of the bracket opens and closes to alternatively expose and conceal the archwire slot, the door replaces the need for a conventional ligature and retains the archwire while providing minimal friction throughout the treatment process. The bracket system is intended to be used throughout orthodontic treatment with an accompanying archwire to move the teeth to the desired occlusion by the clinician. The Carriere SLX 3D Clear bracket has an integral hook design, which allows for the attachment of elastics and other alternate force giving mechanisms to assist the clinician in producing the desired tooth movement. The bonding surface of the bracket has a mechanical undercut design, allowing the bracket to retain the adhesive and bond to the facial surface of the tooth. The application and removal of the Carriere SLX 3D Clear orthodontic ceramic bracket is similar to that of other orthodontic ceramic brackets. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding.
This document describes a 510(k) premarket notification for the "Carriere SLX 3D Clear" orthodontic ceramic bracket. This is a medical device, not an AI/ML powered device, so many of the questions related to AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable.
Here's an analysis of the provided information, focusing on the acceptance criteria and supporting studies relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Acceptance Standard (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-1. | "The biocompatibility testing conducted met the requirements of the tests." |
| - Cytotoxicity | Met ISO 10993-1 requirements. | Passed |
| - Sensitization | Met ISO 10993-1 requirements. | Passed |
| - Irritation | Met ISO 10993-1 requirements. | Passed |
| Bond Strength Testing (Shear Bond Strength) | Substantially equivalent to predicate device, < 8.2 MPa (literature value for no enamel damage). | Carriere SLX 3D Clear: 23.31 lbf / 7.63 MPa (Lower than predicate) |
| Predicate Device (Damon 4Clear) Bond Strength | N/A (for direct comparison) | 33.45 lbf / 10.15 MPa |
| Manufacturing Method | Substantially equivalent to predicate device. | Ceramic injection molded and assembled |
| Material Composition | Substantially equivalent to predicate device. | Polycrystalline Alumina / 304 Stainless Steel |
| Functional Characteristics (e.g., In/Out, Torque, Angulation, Rotation) | Similar to predicate device (acknowledging minor variations due to prescription/tooth position). | Values are similar but not identical to predicate; differences are described and justified. |
| Intended Use | Same as predicate device. | "Intended to aid in the movement of teeth during orthodontic treatment." (Same as predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify sample sizes or data provenance for the biocompatibility and bond strength tests. For such physical property tests, standards often dictate the number of samples. The data provenance would typically be from laboratory testing. It is not an AI/ML device, so there is no "test set" in the sense of a dataset for an algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. This is a physical medical device.
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
Not applicable. This is a physical medical device, not an AI-powered diagnostic/assistance tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is adherence to internationally recognized standards (ISO 10993-1) and passing specified tests (cytotoxicity, sensitization, irritation).
For bond strength, the "ground truth" is the measured shear bond strength compared against established literature values for safe de-bonding (e.g., < 8.2 MPa to avoid enamel damage) and comparison to a predicate device.
For other physical and functional characteristics, the "ground truth" is the measured properties of the device and comparison to the predicate device and engineering specifications.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device.
Ask a specific question about this device
Page 1 of 1