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American Orthodontics' BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

BracePaste™ Adhesive is a light-curing adhesive used as an orthodontic bonding agent for metal brackets, ceramic brackets and buccal tubes. The adhesive will be offered in syringe and carpule containers which will allow a precise volume to be dispensed during orthodontic treatment.

The flow consistency (medium viscosity) of the adhesive allows for easy manipulation, yet does not allow bracket "drift" during placement. The flowable consistency also allows for precise dispensing and application of the adhesive.

The adhesive contains Bis GMA and Bis EMA as resin fillers. A combination of silanized strontium aluminum boron silicate glass and silanized silica is used as fillers (Silane Treated Quartz; Silane Treated Silica). The inorganic loading is approximately 72% by weight.

When exposed to light by a photoinitiator system, the methacrylate functionalities of the resin and fillers undergo a polymerization reaction which hardens or "cures" the adhesive. The adhesive in turn will create a "bond" to which the orthodontic appliance becomes attached to etched enamel surface.

The American Orthodontics' BracePaste™ Adhesive is an orthodontic bonding agent intended for use with metal brackets, ceramic brackets, and buccal tubes to the tooth's surface. The submission includes performance testing to demonstrate its substantial equivalence to the predicate device, Transbond™ XT (K880393).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the performance of the predicate device, Transbond™ XT, as the acceptance criteria for the BracePaste™ Adhesive. The study aims to show comparable performance.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for each non-clinical performance test (e.g., number of specimens tested for bond strength, Young's Modulus, etc.).

The data provenance is from non-clinical bench testing performed by American Orthodontics and "side-by-side comparison performed by the original manufacturer." This suggests the data is prospective in nature, as it was generated specifically for this submission. The country of origin of the data is not specified, but it's generated by American Orthodontics, a U.S.-based company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This question is not applicable as the described tests are non-clinical (bench testing) and do not involve human interpretation or subjective assessments that would require experts to establish ground truth. The "ground truth" for these tests is the quantitative measurement obtained through standardized test methods (e.g., ISO, DIN standards).

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as point 3. Bench tests do not involve 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:

This question is not applicable. The device is an orthodontic adhesive, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant. The testing conducted is non-clinical performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. The device is an orthodontic adhesive, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, the "ground truth" is the quantitative measurements obtained through standardized physical and mechanical testing protocols (e.g., ISO 29022:2013, DIN 13990-1, DIN 13990-2, ISO 4049:2009, ISO 10993-5). The predicate device's performance serves as a comparative benchmark for these measurements.

8. The Sample Size for the Training Set:

This question is not applicable. The BracePaste™ Adhesive is a physical medical device (an adhesive), not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reasons as point 8.

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