(179 days)
The indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.
The product is a denture system consisting of monomer and polymer powder and liquid components.
The provided 510(k) summary (K102874) details the substantial equivalence of New Stetic Acrylics to a predicate device, Myerson's Economy Denture Base Material (K970522). The "study" that proves the device meets acceptance criteria is a series of non-clinical performance tests conducted by New Stetic, aligning with specific international standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the New Stetic Acrylics are based on ANSI/ADA Specification No. 12:2002/ISO 1567:1999 (and 2008 for heat-polymerized acrylics) for Denture Base Polymers. The reported performance for both heat-polymerized and self-polymerized acrylics (which include New Stetic Acrylics) shows that they meet or exceed these requirements.
Heat-Polymerized Acrylics (e.g., Opti-cryl, Veracil, Novacryl, Poti-cryl Pour and EZ-cryl)
| Parameters | Acceptance Criteria (ANSI/ADA SPEC. N° 12:2002/ISO 1567:2008) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Absorption | Not higher than 32 µg/mm³ | 18.10 µg/mm³ | Yes |
| Solubility | Not higher than 1.6 µg/mm³ | 0.8 µg/mm³ | Yes |
| Flexure Strength | 65 MPa Minimum | 70.8 MPa | Yes |
| Flexural Modulus | 2000 MPa Minimum | 5300 MPa | Yes |
| Residual Monomer Content | 2.2% Maximum (In weight) | 0.98% | Yes |
Self-Polymerized Acrylics (e.g., Duracryl, O-cryl and Fidelity)
| Parameters | Acceptance Criteria (ANSI/ADA SPEC. N° 12:2002/ISO 1567:2008) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Absorption | Not higher than 32 µg/mm³ | 19.50 µg/mm³ | Yes |
| Solubility | Not higher than 8.0 µg/mm³ | 5 µg/mm³ | Yes |
| Flexure Strength | 60 MPa Minimum | 65.4 MPa | Yes |
| Flexural Modulus | 1500 MPa Minimum | 3700 MPa | Yes |
| Residual Monomer Content | 4.5% Maximum (In weight) | 1.45% | Yes |
Qualitative Properties:
| Parameters | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Color | Within accepted limits | Within accepted limits | Yes |
| Polishing Capacity | Within accepted limits | Within accepted limits | Yes |
| Translucency | Within accepted limits | Within accepted limits | Yes |
| Porosity | Free from imperfections and porosity | Free from imperfections and porosity | Yes |
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of specimens tested) for each physical property. It only mentions that "All testing that is required has been performed" and presents the experimental results.
- Data Provenance: The testing was conducted in New Stetic's Quality Control Laboratory. New Stetic is located in Guarne, Antioquia, Colombia. Therefore, the data provenance is Colombia and the data is retrospective as it was collected for the purpose of the 510(k) submission based on existing testing protocols.
3. Number of Experts and Qualifications for Ground Truth
This submission pertains to the physical and chemical properties of a dental material, not a diagnostic device requiring expert interpretation of images or other subjective data. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense (e.g., radiologists, pathologists) is not applicable. The "ground truth" here is defined by the technical specifications of the ANSI/ADA and ISO standards, and the measurements are performed using calibrated laboratory equipment.
4. Adjudication Method
Not applicable. As described above, this is a non-clinical performance evaluation against established objective standards using laboratory equipment, not a subjective assessment requiring human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study is typically conducted for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission describes the testing of a dental material's physical properties.
6. Standalone Performance
Yes, in a sense. The reported performance data represents the standalone (algorithm-only, if considering the testing methodology as an "algorithm") performance of the New Stetic Acrylics samples as measured by laboratory equipment against predefined standards. There is no human-in-the-loop component in determining these physical properties.
7. Type of Ground Truth
The type of ground truth used is expert consensus/established standards. Specifically, the ground truth is defined by the requirements outlined in ANSI/ADA Specification No. 12:2002/ISO 1567:1999 (and 2008) for Denture Base Polymers. These standards are developed by industry experts and regulatory bodies to ensure the safety and effectiveness of dental materials.
8. Sample Size for the Training Set
Not applicable. This submission describes the performance testing of a physical material, not an AI or machine learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.