(114 days)
ARGEN PMMA Discs are polymethylmethacrylate blanks for dental use. These blanks are used to mill long-term temporary substructures for crowns & bridgework. The blanks are intended to be used in various CAD/CAM systems.
Polymethylmethacrylate (PMMA) discs or blanks for use in dental CAD/CAM systems.
The provided regulatory submission describes a 510(k) premarket notification for the ARGEN PMMA device, a polymethylmethacrylate (PMMA) disc for dental CAD/CAM systems. The submission asserts substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the information required to directly answer some of the questions (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods) is not explicitly detailed in the provided documents. The approach taken is a comparison of material properties to demonstrate equivalence.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, "acceptance criteria" are implied by demonstrating that the ARGEN PMMA device has comparable physical and chemical properties and biological performance to its predicate devices. The reported "performance" is that these properties are similar or identical.
| Property / Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ARGEN PMMA) |
|---|---|---|
| Composition | Polymethylmethacrylate (PMMA) hot cured polymer | Polymethylmethacrylate (PMMA) hot cured polymer |
| Indications for Use | Used to mill long-term temporary substructures for crowns & bridgework in CAD/CAM systems | Used to mill long-term temporary substructures for crowns & bridgework in CAD/CAM systems |
| Physical Properties | Similar e-modulus, flexural strength, and deflection to predicates | Comparable e-modulus, flexural strength, and deflection to predicates |
| Chemical Properties | Similar to predicates | Similar to predicates |
| Polymerization Grade | High | High |
| Aesthetic Function | Same as predicates | Same as predicates |
| Biological Performance | Non-toxic, same as substantially equivalent Dental Acrylic teeth | Non-toxic, same as substantially equivalent Dental Acrylic teeth |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The submission relies on comparative data and general material properties rather than a specific test set for performance validation in the typical sense of a diagnostic or therapeutic device study.
- Data Provenance: Not explicitly stated. The tests conducted (ASTM F895-84:1984, ISO 10993.5:1999, US Pharmacopeia XXVIII) are international standards, suggesting data would be generated according to these protocols, but the specific origins are not mentioned.
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/Not mentioned. The submission is not a clinical study involving expert interpretation of results, but rather a materials science comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. No expert adjudication process is described for this type of submission.
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 device is a dental material (PMMA discs), not an AI-powered diagnostic or therapeutic system. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on established material science standards and properties of the predicate devices. The claim is that ARGEN PMMA meets these established material characteristics. For biological performance, it refers to the non-toxic nature of PMMAresin, which is a widely accepted characteristic in dentistry.
8. The sample size for the training set
- Not applicable. This type of submission does not involve a "training set" in the context of machine learning or statistical modeling.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in this context.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.