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510(k) Data Aggregation
(85 days)
Embrace Pit and Fissure Sealant, Low Fill is a professional dental material, designed with no Bisphenol A, that contains fluoride releasing, light cured, glass-filled acrylate resins and is less than 10% filled. Embrace Pit and Fissure Sealant, Low Fill is available in two shades (tooth-colored and off-white) and is used to seal the pits and fissures in teeth.
Embrace Pit and Fissure Sealant, Low Fill is a fluoride releasing, light-cured acrylate resin, with no Bisphenol A, that is less than 10% filled and is available in two shades, tooth-colored and off-white.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Embrace™ WetBond™ Pit and Fissure Sealant, Low Fill" device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes performance testing (bench testing) for the device. It does not explicitly state "acceptance criteria" in a pass/fail sense, but rather lists measured performance characteristics which are presumably considered acceptable given the conclusion of substantial equivalence.
| Performance Metric | Reported Device Performance |
|---|---|
| Density / Specific gravity | 1.160 g / mL |
| Working time in ambient light | > 5 minutes |
| Light cure setting time | 20 seconds |
| Depth of cure after 20 second light cure | 1.88 mm |
| Film thickness | 9 µm |
| Compressive Strength | 33,120 ± 3000 p.s.i. / 228 ± 21 MPa |
| Diametral Tensile Strength | 5,365 ± 300 p.s.i. / 37 ± 2 MPa |
| Film Thickness (repeated entry) | 9 µm |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing. It does not specify the sample sizes used for each of the performance metrics. The data provenance is from bench laboratory testing conducted by PULPDENT CORPORATION. It is not clinical data, so terms like "retrospective" or "prospective" for human subjects do not apply here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study described is bench testing of physical/chemical properties, not a study involving human subjects or expert assessment for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the study described is bench testing of physical/chemical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The study focuses on bench testing of material properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
No, a standalone study in the context of an algorithm's performance was not conducted or described. This device is a dental material, not an AI or software device.
7. The Type of Ground Truth Used:
The "ground truth" for the bench tests would have been established by standard scientific measurement techniques and established protocols for each material property (e.g., using a universal testing machine for compressive strength, a light meter for cure time, etc.). It's based on objective physical and chemical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is a physical product undergoing bench testing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set.
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