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510(k) Data Aggregation
(200 days)
It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.
Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%95%), ferric chloride (09%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%1%) and Yttrium chloride(012%).
The document describes the Pre-Sintered Zirconia Coloring Liquid and its non-clinical testing for safety and performance.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Testing of Pre-Sintered Zirconia Coloring Liquid | |
| Specification: Product technical requirements | Pass |
| Appearance: Homogeneous and impurity-free liquid | Pass |
| Post-dyeing comparison requirements: No significant difference in color between dental specimens and VITA veneer colorimeter or standard dental specimens | Pass |
| Heavy metal content: Less than 10 mg/L (in Pb) | Pass |
| Biocompatibility Testing | |
| Cytotoxicity (ISO 10993-5:2009): Non-cytotoxic | Pass |
| Delayed hypersensitivity (ISO 10993-10:2010): Non-Delayed hypersensitivity | Pass |
| Intradermal reaction (ISO 10993-10:2010): Non-Intradermal reaction | Pass |
| Acute systemic toxicity (ISO 10993-11:2017): Non-Acute systemic toxicity | Pass |
| Subchronic systemic toxicity (ISO 10993-11:2017): Non-Subchronic systemic toxicity | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for each physical and biocompatibility test. It mentions "dental specimens" for the post-dyeing comparison and implies testing on samples for heavy metal content, cytotoxicity, hypersensitivity, intradermal reaction, and systemic toxicity. The provenance of the data is not explicitly stated beyond being "non-clinical testing" conducted on the subject device. It is assumed to be internal testing by Chengdu Besmile Medical Technology Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the involvement of experts for establishing ground truth in the non-clinical tests described. The "ground truth" for these tests would be defined by the standardized methodologies (e.g., ISO standards for biocompatibility, instrumental measurements for heavy metals, visual comparison against color guides for post-dyeing).
4. Adjudication method for the test set
Not applicable for these types of non-clinical tests. The tests rely on objective measurements and adherence to specified standards rather than expert adjudication.
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 pre-sintered zirconia coloring liquid, not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material product, not a software algorithm.
7. The type of ground truth used
- Physical Testing: Ground truth is established by:
- Specification: Product technical requirements.
- Appearance: Visual inspection against established criteria (homogeneous and impurity-free).
- Post-dyeing comparison: Comparison against VITA veneer colorimeter or standard dental specimens.
- Heavy metal content: Analytical measurement against a specified threshold (less than 10 mg/L in Pb).
- Biocompatibility Testing: Ground truth is established by adherence to the criteria defined in the specific ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11) for non-cytotoxicity, non-hypersensitivity, non-intradermal reaction, and non-systemic toxicity.
8. The sample size for the training set
Not applicable. This device is a material product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is relevant for this device.
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