(219 days)
- For direct restorations, for use in all classes of cavities, including veneers and incisal edge repairs.
- For indirect anterior and posterior restorations, including inlays, onlays, and veneers.
AXIOM is a light-cured hybrid dental restorative composite material, comprised of a Bis-GMA based resin, barium glass filler and fumed silica, suitable for dental filings. The cured product has a high surface luster, high strength and good wear resistance.
Here's a breakdown of the information you requested, based on the provided text:
This submission is for a dental restorative composite material, not an AI-powered diagnostic device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context. The provided text describes a 510(k) submission for a physical medical device (dental filling material) and focuses on demonstrating substantial equivalence to predicate devices through comparative bench testing and material safety.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Parameters) | Reported Device Performance (AXIOM) | Study Proving Acceptance |
|---|---|---|
| Diametral strength | Found to be similar to predicate devices / within acceptable range | Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4). The submission states: "This is further validated by the comparative bench test conducted; diametral strength, flexural strength, Young's modulus, shrinkage, and hardness." |
| Flexural strength | Found to be similar to predicate devices / within acceptable range | Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4). |
| Young's modulus | Found to be similar to predicate devices / within acceptable range | Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4). |
| Shrinkage | Found to be similar to predicate devices / within acceptable range | Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4). |
| Hardness | Found to be similar to predicate devices / within acceptable range | Comparative bench testing against predicate devices (3M Z100 Restorative, Kerr Corporation Prodigy 4). |
| Cytotoxicity | Non-cytotoxic | Testing for cytotoxicity. The submission states: "AXIOM has been tested for cytotoxicity and mutagenicity and were found to be non-cytotoxic and non-mutagenic." |
| Mutagenicity | Non-mutagenic | Testing for mutagenicity. The submission states: "AXIOM has been tested for cytotoxicity and mutagenicity and were found to be non-cytotoxic and non-mutagenic." |
Key takeaway: The acceptance criteria for this device are based on demonstrating comparable physical and safety properties to existing, legally marketed predicate devices through specific bench tests.
Information Not Applicable to This Device (as it is not an AI/diagnostic device)
- Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to samples of the material used in laboratory bench tests, not patient data for a diagnostic algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical material's properties is established through standardized laboratory measurements, not expert review of images or data.
- Adjudication method for the test set: Not applicable. Laboratory test results are objective measurements.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for an AI diagnostic algorithm, not a dental filling material.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: For the physical/safety tests, the ground truth is the objective measurement from the specified laboratory tests (e.g., a measured MPa for flexural strength). For claims of "similar to predicate," the ground truth is the established performance characteristics of the predicate devices.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of the 510(k) process for AXIOM:
The manufacturer, Tri Dental Innovators, submitted AXIOM, a light-cured hybrid dental restorative composite, for 510(k) clearance. Their primary method of demonstrating safety and effectiveness was through showing substantial equivalence to existing predicate devices (3M Z100 Restorative and Kerr Corporation Prodigy 4). This was achieved by:
- Component Comparison: Stating that all components of AXIOM are found in legally marketed predicate devices and share similar technological characteristics based on monomer chemistry.
- Comparative Bench Testing: Conducting specific laboratory tests (diametral strength, flexural strength, Young's modulus, shrinkage, and hardness) to show that AXIOM performs comparably to the predicate devices.
- Biocompatibility Testing: Demonstrating that AXIOM was non-cytotoxic and non-mutagenic.
The FDA reviewed this information and determined that AXIOM was substantially equivalent for its intended use (all classes of cavities), allowing it to be marketed.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.