(90 days)
Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.
American Orthodontics' BracePaste MTP Light Cure Primer is a light-curing primer that is intended to be used in direct or indirect bonding procedures of brackets and tubes. The primer prepares the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The primer "wets" the bonding surface of the object to be bonded [i.e. enamel, composite materials, etc.) to promote adhesion. The primer will be available in liquid form in a dropper bottle.
The primer contains Bisphenol a Diglycidyl Ether Dimethacrylate and 2-Hydroxyethyl Methacrylate resin compounds. These resin compounds are mixed with ethyl alcohol and water to form an aqueous solution. This solution has the hydrophilic characteristics necessary for the primer to adhere under wet conditions. Using a curing light, the irradiation causes the methylacrylate resins to undergo polymerization. This polymerization forms a bond between the etched enamel surface and the bracket adhesive.
The document describes the BracePaste MTP Light Cure Primer (K181910), an orthodontic primer, and its substantial equivalence to a predicate device, the Transbond MIP Primer (K962785). The primary acceptance criteria for such a device are related to its bond strength and other physical/chemical properties to ensure it performs as intended.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" values for bond strength. Instead, it presents a comparison of the subject device's performance against the predicate device, implying that performance similar to the predicate is the basis for acceptance.
| Test Method | Predicate Device Performance (Transbond MIP Primer) | Subject Device Performance (BracePaste MTP Light Cure Primer) | Implicit Acceptance Criteria (based on predicate) |
|---|---|---|---|
| Average Bond Strength | 38.70 N/mm² | 38.94 N/mm² | Similar to or better than 38.70 N/mm² |
| Refractive Index (20.0°C) | 1.4441 | 1.4284 | Within a comparable range of 1.4441 |
The conclusion states that the BracePaste MTP Light Cure Primer "performs as well as the predicate Transbond MIP Primer," indicating that matching or exceeding the predicate's performance is the criterion for determining efficacy and suitability.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size in terms of the number of individual tests or specimens used for the non-clinical performance tests.
Data Provenance: The studies are described as "in-house testing" and "side-by-side comparison performed by the original manufacturer." This indicates the data is retrospective and likely originated from internal laboratory testing. The country of origin is not specified but is implicitly the location of the manufacturer (American Orthodontics, Sheboygan, Wisconsin, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an orthodontic primer, and the studies performed are non-clinical (in vitro and bench testing). The "ground truth" for these types of tests (like bond strength or refractive index) is established by direct physical measurement, not by expert interpretation or consensus.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is based on direct physical measurements from bench tests, there is no need for expert adjudication.
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 device (orthodontic primer), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical performance tests (e.g., average bond strength, refractive index) is derived from direct physical and chemical measurements obtained through standardized laboratory testing (e.g., DIN 13990-2, ISO 29022:2013).
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not a machine learning algorithm.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.