(210 days)
Ascent F-Coat is indicated for the coating of exposed dentin under temporary restorations, and for the treatment of hypersensitive teeth.
The Ascent F-Coat cavity varnish is an ethanol based varnish agent containing 5% sodium fluoride. The material is applied to tooth surfaces where hypersensitivity is a concern The varnish is applied by a dentist to intact tooth surfaces, or to exposed dentin as a pre-I he varilish is upplication of temporary restorative materials. The material is a white opaque treamient prof to upprication of temperation of the present of in preloaded dispensing syringes with disposable brush tips.
The provided text describes a 510(k) summary for a dental product called Ascent F-Coat, which is a cavity varnish. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for a novel medical device that would typically involve extensive performance data and clinical trials.
Therefore, many of the requested categories for a comprehensive study report (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance) are not explicitly present in the provided text. The information available is mainly related to laboratory testing demonstrating equivalence.
Here's an analysis of the available information based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Ascent F-Coat) |
|---|---|
| Fluoride Ion Concentration | Contains fluoride ion at the labeled concentration of 5% or 22,600ppm. |
| Adhesion to Tooth | Provides adhesion to the tooth of 77kPa. |
| Penetration of Exposed Dentin Tubules | Capable of penetrating exposed dentin tubules to a minimum of 3-5 microns (based on photomicrographs). |
| Prevention of Fluid Ingress (Dye Penetration) | Substantially equivalent to predicate devices in preventing the ingress of fluids into the exposed dentin tubules (based on laboratory dye penetration tests). |
| Biocompatibility | Conforms to ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for any of the laboratory tests (e.g., how many teeth were tested for adhesion, how many samples for dye penetration).
- Data provenance is not explicitly stated. The tests are described as "Laboratory testing," implying they were conducted in a lab environment. There is no indication of retrospective or prospective human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The performance data seems to be based on objective laboratory measurements rather than expert human assessment for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as the performance data is based on laboratory measurements, not subjective evaluations requiring adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a dental varnish, not an AI-powered diagnostic tool, so such a study would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental product, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data appears to be objective physical and chemical measurements (e.g., fluoride concentration, adhesion force, penetration depth, dye penetration inhibition). Biocompatibility would be assessed against the ISO standard.
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The sample size for the training set:
- Not applicable. This is a physical product, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the Study (as described):
The "study" described is a series of laboratory tests demonstrating that the Ascent F-Coat cavity varnish is "substantially equivalent" to two legally marketed predicate devices (Vanish Varnish and DuraShield). The focus is on demonstrating similar technological characteristics and performance rather than proving a novel clinical benefit through a large-scale clinical trial.
The key findings from these laboratory tests are:
- The device contains the labeled 5% (22,600ppm) sodium fluoride.
- It provides an adhesion to the tooth of 77kPa.
- Photomicrographs show it penetrates exposed dentin tubules to a minimum of 3-5 microns.
- Dye penetration tests indicate it is "substantially equivalent" to predicate devices in preventing fluid ingress into dentin tubules.
- It conforms to the ISO 7405:2008 standard for biocompatibility.
The purpose of these tests was to support the claim of substantial equivalence for 510(k) clearance, asserting that the device does not raise new questions of safety or effectiveness compared to predicate devices.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.