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510(k) Data Aggregation
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BracePaste Fluoride Sealant
BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel.
BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.
The provided document describes the FDA 510(k) clearance for the BracePaste Fluoride Sealant. It is a submission for a dental device, specifically a light-cure primer/sealant for orthodontic bonding. As such, it does not involve AI/ML technology or image processing. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.
The acceptance criteria and study information provided in the document are primarily for demonstrating substantial equivalence to a predicate device (Opal Seal) through non-clinical performance and biocompatibility testing.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets for each performance test. Instead, it states that "Results of all conducted testing was found acceptable and does not raise any new issues of safety or effectiveness." and "Results of bench testing indicate that BracePaste Fluoride Sealant performs as well as the predicate Opal Seal." This implies that the acceptance criteria are met if the new device's performance is comparable to or performs as well as the predicate device or meets established standards (e.g., ISO 29022:2013 for Shear Bond Strength).
However, based on the non-clinical performance tests listed, here's a conceptual table:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Shear Bond Strength (ISO 29022:2013): Must be comparable to or perform as well as the predicate device. | Performed the test. Results were found acceptable and indicate performance as well as the predicate Opal Seal. (Specific values not provided) |
| Stability: Maintain performance characteristics over shelf life. | Stability Study conducted. Results found acceptable. 3-year shelf life under recommended storage conditions (3-25 °C). |
| Interaction with Accessories: Compatible with intended accessories. | Test conducted. Results found acceptable. |
| Fluoride Measurements: Demonstrate fluoride release/presence. | Test conducted. Results found acceptable. (Presence of Fluoride: Yes) |
| Depth of Cure: Achieve adequate curing depth. | Test conducted. Results found acceptable. |
| Evaluation of Reapplication: Performance after reapplication. | Test conducted. Results found acceptable. |
| Water Sorption and Water Solubility: Meet dental material standards. | Test conducted. Results found acceptable. |
| Evaluation of Air Dry, Tack Cure: Demonstrate proper handling characteristics. | Test conducted. Results found acceptable. |
| Biocompatibility (ISO 7405, ISO 10993-1): No adverse biological reactions. | Biocompatible per ISO 7405, ISO 10993-1. Specific tests conducted include Cytotoxicity (Direct Contact & Elution), Acute Systemic Toxicity, Genotoxicity (Bacterial Reverse Mutation & Mouse Lymphoma Assay), Irritation (Intracutaneous Reactivity), Sensitization (Delayed Hypersensitization), and Subacute/Subchronic Systemic Toxicity. All results found acceptable. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each non-clinical test conducted (e.g., how many samples were tested for Shear Bond Strength). It only lists the types of tests.
Given the nature of the device and studies (non-clinical bench testing), data provenance typically refers to the testing being performed in an accredited lab, often in the country of the manufacturer. However, this specific detail (country of origin for the data) is not provided in the document. All testing described is prospective, as it was conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a non-clinical bench testing submission for a dental material, not an AI/ML device requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical bench testing submission for a dental material.
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 non-clinical bench testing submission for a dental material, not an AI-assisted diagnostic or treatment planning device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-clinical bench testing submission for a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for non-clinical performance testing typically refers to:
- Established physical and chemical standards: For tests like depth of cure, water sorption, water solubility, and fluoride measurements, the ground truth is often defined by industry standards or specifications for dental materials.
- Predicate device performance: For comparative tests like shear bond strength, the "ground truth" or benchmark is the performance of the legally marketed predicate device (Opal Seal).
- Biocompatibility standards: For biocompatibility, the ground truth is defined by international standards like ISO 10993 series and ISO 7405, which specify acceptable limits for various biological responses.
8. The sample size for the training set
Not applicable. This is a non-clinical bench testing submission for a dental material; there is no "training set" as it does not involve AI/ML.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
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