(85 days)
Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis.
Biomic Color Opaque is a liquid primarily composed of Methylacryloyl propyl trimethoxy silane, deionized water, 1, 3-butanediol, ferric chloride, citric acid, cerium nitrate, erbium nitrate, cobaltous nitrate, manganous acetate, and aluminum nitrate.
This product is designed for use on the internal surface of dental zirconia material prostheses. It penetrates tightly with the zirconia surface, forming an extremely thin shade layer that reduces the internal surface permeability of the zirconia material prosthesis. The devices are intended to be used solely by dental technicians for the fabrication of zirconia restorations for individual dental patients.
For staining, the zirconia materials must be immersed into the staining solution or brushed with the liquid before sintering at high temperature. The staining solution consists of two components: Type I - a color component (A、B、C、D、W、L、M、R、S、X), and Type II - an OP component, 1:1 collocation is recommended. These components are mixed together for use on the zirconia material to achieve the desired shade.
The provided FDA 510(k) clearance letter and its accompanying summary for the "Biomic Color Opaque" device do not contain information about clinical studies or performance data related to AI/algorithm-driven performance, ground truth establishment, or multi-reader multi-case (MRMC) studies.
The document explicitly states under Section 7.0, "Summary of Clinical Test," that "Clinical testing was not required for this submission." This indicates that the device's clearance was based on non-clinical data (bench testing, biocompatibility, sterility, shelf-life) and a comparison to a predicate device, not on AI/algorithm performance. The device itself is a "Porcelain Powder For Clinical Use" (specifically a pre-sintered zirconia coloring liquid), not an AI-driven diagnostic or image analysis tool.
Therefore, it is impossible to provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/algorithm-driven study based solely on the provided text.
However, I can extract the acceptance criteria and performance related to the physical and chemical properties of the device, as that is the type of testing described.
Here's a summary of the acceptance criteria and performance as described for this specific device (a coloring liquid), not for an AI algorithm:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Acceptance Criteria Category | Specific Test Items (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Physical and Mechanical Properties | - Appearance | Verified to meet acceptable criteria |
| - Uniformity | Verified to meet acceptable criteria | |
| - No Foreign Matter | Verified to meet acceptable criteria | |
| - Flexural Strength | Verified to meet acceptable criteria | |
| - Chemical Solubility | Verified to meet acceptable criteria | |
| - Linear Expansion Coefficient | Verified to meet acceptable criteria | |
| Biocompatibility | - Cytotoxicity (ISO 10993-5) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) |
| - Sensitization (ISO 10993-10) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - Oral Mucosa Irritation (ISO 10993-23) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - Acute Systemic Toxicity (ISO 10993-11) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - Pyrogen Test (ISO 10993-11) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - Subcutaneous Implant Test (ISO 10993-6) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - Bacterial Reverse Mutation Test (ISO 10993-3) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - TK Gene Mutation Test (ISO 10993-3) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| - Chemical Characterization Study (ISO 10993-18) | Addressed and performed according to standards (ISO 10993-1, ISO 7405) | |
| Sterility and Shelf-Life | - Sterility | Provided non-sterile |
| - Shelf-Life | 18 months (based on testing report) |
Regarding the AI/Algorithm-Specific Questions:
Since the device is a dental coloring liquid and not an AI-driven device, the following information is not applicable or not provided in the document:
- Sample size used for the test set and the data provenance: Not applicable; no AI test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth for AI performance required.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. The ground truth for this device's performance relates to its physical/chemical conformity to standards.
- The sample size for the training set: Not applicable; no AI training set.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided FDA document details the regulatory clearance for a traditional medical device (dental coloring liquid) based on its physical, chemical, and biological properties, and its substantial equivalence to a predicate device. It does not pertain to the evaluation of an AI-powered medical device.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.