(84 days)
Enamelite Acryseal and Enamelite Acryseal-CB Spray Sealant is intended for use as a sealant/bonding agent intended to reline, repair, or rebase denture surfaces and CAD/CAM produced/milled acrylic and composite replacement dental restorations.
Enamelite Acryseal Spray Sealant is a dental sealant or bonding agent which is packaged for aerosol dispensing. The product is formulated as either an acrylic spray sealer or composite spray sealer. The base product is identical to brush on sealants that have been used for over 40 years in the dental profession. The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method and was designed to replace the outdated brush application of sealing/bonding lacquer.
The provided text is a 510(k) summary for the Enamelite Acryseal Spray Sealant and Enamelite Acryseal-CB Spray Sealant. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence and does not typically involve the detailed "acceptance criteria" and "study proving the device meets acceptance criteria" in the same way a novel device might go through a rigorous clinical trial with specific performance metrics.
Instead, the submission argues that the new device has "similar technical features, indications for use, and the safety and effectiveness of the devices is equivalent" to predicate devices. This implies that the 'acceptance criteria' are met indirectly by demonstrating equivalence to devices already accepted by the FDA.
Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not directly available or applicable within this 510(k) summary.
Here's how to interpret the request in the context of the provided document:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied by Substantial Equivalence): The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to one or more predicate devices. This means that the new device is as safe and effective as the predicate, either because it has the same technological characteristics, or if it has different characteristics, these do not raise new questions of safety and effectiveness, and the device is as safe and effective as the predicate.
- Reported Device Performance: The document does not provide specific quantitative performance metrics like sensitivity, specificity, accuracy, or other statistical measures. Instead, it describes the physical and chemical properties and intended function of the device and states that these are equivalent to the predicate devices.
- Description: "The spray on sealant and bonding agent produces the same finished material surface as commonly used brush-on sealants. Enamelite Acryseal Spray sealing and bonding agent produces a much smoother coating compared to a brush-on method..."
- Technological Characteristics: Specifies compositions (Methyl Methacrylate Solids and Monomers for Acryseal, 2-Methyl-2-Propenoic Acid and Triethylene Glycol Dimethacrylate for Acryseal-CB, with potential fillers).
- Functionality: "Product is sprayed onto dental fixtures in very light or thin coats. The dental acrylic sealant begins its chemical bonding process as soon as the material hits the surface of the dental fixture. The acrylic sealant can be air cured in 5 minutes and the composite sealant can be light cured in 90 seconds. Spray sealant facilitates a smooth even layer of material when sprayed onto dental fixtures. Surface porosity and any scratches are sealed and smoothed over to a glossy smooth surface to make cleaning easier and help prevent the growth of harmful bacteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the 510(k) summary. For a 510(k) based on substantial equivalence to existing devices, extensive new clinical trial data or performance testing with specific "test sets" of data, as might be done for an AI/ML device, is often not required or detailed in the summary if the technological characteristics are sufficiently similar to predicates.
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):
- This information is not provided as there is no mention of a "test set" and associated "ground truth" derived from expert review in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/provided for the reasons stated above.
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 information is not applicable/provided. This device is a dental sealant/bonding agent, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/provided. This device is a physical product (a spray sealant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not applicable/provided. The submission is not based on a ground truth derived from clinical data in the traditional sense for evaluating device performance against a gold standard. Instead, it relies on the known or established performance of predicate devices and the chemical/physical properties of the new device relative to those predicates.
8. The sample size for the training set:
- This information is not applicable/provided. This is a physical product, not a software algorithm that would require a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable/provided.
In summary: The provided 510(k) document is a regulatory submission for a physical dental product (sealant) demonstrating substantial equivalence to pre-existing, legally marketed predicate devices. It does not contain the kind of detailed performance study data, acceptance criteria, sample sizes, or expert ground truth establishment that would be found in a submission for a novel, AI-driven diagnostic device. The "acceptance criteria" here are implicitly met by demonstrating that the device is "as safe and as effective" as its predicate devices, based on similar indications for use, technological characteristics (materials, physical form, application), and anticipated performance.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.