(326 days)
Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.
Coloring liquid are water-based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperature.
The provided text is a 510(k) summary for a medical device called "Coloring Liquid." This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the format typically used for AI/ML-based diagnostic devices.
Therefore, many of the requested sections (acceptance criteria for a diagnostic device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size, standalone performance, ground truth types) are not applicable or not provided in this regulatory submission.
The document primarily addresses the safety and effectiveness of the Coloring Liquid through comparison to a legally marketed predicate device and non-clinical bench testing.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available:
Device Name: Coloring Liquid
1. A table of acceptance criteria and the reported device performance
For this device, the "acceptance criteria" are primarily based on demonstrating similar properties and performance to the predicate device, particularly regarding safety (biocompatibility) and functional characteristics (coloration of zirconia). Specific quantitative performance metrics typical of diagnostic devices are not present.
| Acceptance Criteria (Bench Testing/Biocompatibility) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5:2009): No cytotoxicity effect | No cytotoxicity effect |
| Oral Mucosa Irritation (ISO 10993-10:2010): Not a primary oral mucosa irritant | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization (ISO 10993-10:2010): Not a sensitizer | Not a sensitizer under the conditions of the study |
| Subchronic Toxicity (ISO 10993-11:2006): No subchronic toxic effects | No subchronic toxic effects observed |
| Genotoxicity (ISO 10993-3:2003): No genotoxic effects | No genotoxic effects observed |
| Functional Equivalence: | |
| Intended Use: Complete or partial coloration of zirconia ceramic materials | Same as predicate |
| Technology: Water based with inorganic pigments | Same as predicate |
| Operating Principle: Brush or immerse zirconia ceramic materials with coloring liquid before sintering | Same as predicate |
| Ingredient similarity (minor differences evaluated) | Similar, with a minor difference in dispersant (polyethylene glycol) deemed safe and not reacting with other ingredients. |
| Non-clinical testing met specifications | All tests were verified to meet acceptance criteria (specific criteria not detailed for coloration performance) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document states "Bench testing was performed" and "Biocompatibility testing was performed," but does not detail the number of samples or specimens used for these tests.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). These are non-clinical (bench and biocompatibility) tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a diagnostic device involving expert interpretation of medical images or data. The "ground truth" for biocompatibility is established by standardized ISO testing protocols.
4. Adjudication method for the test set
Not applicable. There is no human adjudication process described for the non-clinical tests.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
For biocompatibility, the "ground truth" is defined by the results of standardized ISO 10993 series tests (e.g., cytotoxicity, irritation, sensitization, subchronic toxicity, genotoxicity). For functional aspects (coloration), the ground truth is implicitly based on achieving the intended aesthetic effect on zirconia, but specific quantitative metrics or expert evaluations of color matching are not detailed in this summary.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.