(94 days)
Smiletone® (denture base resin) is a thermoplastic resin that is intended to be used in fabrication of removable full and partial dental prosthesis, as well as occlusal splints and night guards. The product is based on a compounded mixture of polyamide and pigments.
Smiletone® is a thermoplastic material to be used for removable full or partial dental prosthesis. The product is based on a compounded mixture of Polyamide and pigments. Smiletone® is classified as 'Type 3-thermoplastic blank or powder' by EN ISO 20795-1[2013].
The provided document describes the 510(k) premarket notification for the Smiletone® denture base resin, not a device with AI or machine learning components. Therefore, many of the requested categories related to AI/ML device studies (such as multi-reader multi-case studies, effect size of AI assistance, expert qualifications for ground truth, adjudication methods, and training/test set sample sizes for algorithms) are not applicable.
However, the document does contain information about performance testing and acceptance criteria for the material.
Here's a summary of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with numerical thresholds against which the device performance is reported. Instead, it states that "All test results were satisfactory" and indicates "Pass" for each test against various standards. The acceptance criteria are implied to be meeting the requirements of the specified standards (e.g., EN ISO 20795-1, ISO 10993 series).
| Test Title | Test Standard | Reported Device Performance (Acceptance Criteria Implicitly Met) |
|---|---|---|
| Dentistry - Medical devices for dentistry - Materials testing | EN 1641 (2010) | Pass |
| Accelerate aging test | ASTM F1980 (2002) | Pass |
| Visual Inspection | Performance test Guidance of dental materials (KFDA 2014) | Pass |
| Capacity test | Performance test Guidance of dental materials (KFDA 2014) | Pass |
| Packaging (Visual Inspection) test | Performance test Guidance of dental materials (KFDA 2014) | Pass |
| Surface characteristics test | EN ISO 20795-1 | Pass |
| Shape characteristics test | EN ISO 20795-1 | Pass |
| Color test | EN ISO 20795-1 | Pass |
| Color Stability test | EN ISO 20795-1 | Pass |
| Translucency test | EN ISO 20795-1 | Pass |
| Freedom from porosity test | EN ISO 20795-1 | Pass |
| Bonding to synthetic polymer teeth test | EN ISO 20795-1 | Pass |
| Residual Monomer test | EN ISO 20795-1 | Pass |
| Sorption test | EN ISO 20795-1 | Pass |
| Solubility test | EN ISO 20795-1 | Pass |
| Ultimate flexural strength test | EN ISO 20795-1 | Pass |
| Genotoxicity test: BACTERIAL REVERSE MUTATION STUDY (AMES) | ISO 10993-3 & OECD 471 Bacterial Reverse Mutation Test | Pass |
| Cytotoxicity Test (Agar diffusion test) | ISO7405:2008 | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11 | Pass |
| Maximization Sensitization Test (LLNA-BrdU) | ISO 10993-10 & OECD 442B:2010 | Pass |
| Oral mucosa irritation test | ISO10993-10:2010 Annex B.3 | Pass |
Note on Physical Properties (Specific Values from Predicate Comparison):
While not explicitly stated as "acceptance criteria" for Smiletone, the comparison table ([6]) provides specific physical property values for Smiletone and its predicates. For Smiletone:
- Flexural strength: 68 ± 2 MPa
- Flexural modulus: 1389 ± 35 MPa
- Water absorption: 30.7 ± 0.2 µg/mm²
- Water solubility: 0.33 ± 0.1 µg/mm²
These values would implicitly need to meet certain ranges or be comparable to the predicates as part of the overall demonstration of substantial equivalence.
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the physical, chemical, and biological tests. It states that tests were performed according to standards (e.g., ISO, ASTM, OECD, KFDA guidance), which typically include requirements for sample size and testing methodology.
The data provenance is not explicitly stated in terms of country of origin of the data, but the testing appears to have been conducted based on international standards (ISO, ASTM, OECD) and a Korean FDA (KFDA) guidance, suggesting either international or Korean testing laboratories. The KFDA guidance implies the reporting entity and potentially the data origin is from Korea. The tests are prospective in the sense that they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material testing study, not an AI/ML device requiring clinical expert ground truth for interpretation.
4. Adjudication method for the test set
Not applicable. This is a material testing study.
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 is a material testing study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material testing study.
7. The type of ground truth used
The "ground truth" for the material testing is based on objective measurements and compliance with established international and national standards for denture base resins (e.g., EN ISO 20795-1 for physical properties, ISO 10993 series and OECD guidelines for biocompatibility). The results are quantitative measurements or qualitative observations (e.g., visual inspection) evaluated against predefined specifications within the standards.
8. The sample size for the training set
Not applicable. This is a material testing study, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a material testing study.
§ 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.