Search Results

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

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.

Ask a specific question about this device

Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of all ceramic restorations for individual dental patients.

Luminesse® Pre-sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse® ZR blanks to provide individualized tooth (or teeth) shading. It is a liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks. Dental restorations are designed and manufactured by a certified dental professional (Technician) using CAD/CAM technology.

The provided document is a 510(k) Pre-Market Notification for a medical device called "Luminesse® Pre-Sintered Zirconia Coloring Liquid." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.

Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study for an AI/software device. Instead, it demonstrates substantial equivalence based on a comparison of technological characteristics and performance data that the new device shares with a predicate device.

Here's a breakdown of the requested information based on the provided document, highlighting where the information is not applicable due to the nature of a 510(k) substantial equivalence submission for this type of device:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for a coloring liquid, the "acceptance criteria" are not framed as performance metrics for an AI or diagnostic device, but rather as characteristics of the material that show it is similar to the predicate. The performance data presented refers to standard physical and chemical properties.

Conclusion from Document: The document concludes that "the differences…do not raise new questions of safety and effectiveness." The data supplied for both new and predicate device on physical and mechanical properties demonstrate similarity, "albeit unequal results," and are "within the expected specifications for zirconia dying liquid materials for dental application."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A): This is a 510(k) submission for a coloring liquid, not a diagnostic or AI device that typically involves test sets of patient data. The "test set" here refers to the samples of the coloring liquid itself that were tested for physical and chemical properties. There is no mention of the specific number of liquid samples tested, nor is there information about data provenance in terms of country of origin or retrospective/prospective studies. The performance data is based on material property testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable (N/A): Ground truth established by experts is relevant for diagnostic or AI systems where human interpretation is the gold standard. For a coloring liquid, the "ground truth" is determined by objective physical and chemical measurements (e.g., pH, density, boiling point), which are standard laboratory procedures, not expert consensus on qualitative data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretation, typically in studies involving human readers or AI. This is not relevant for the objective physical and chemical testing of a dental coloring liquid.

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 (N/A): MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing multiple readers on multiple cases. This device is a coloring liquid, not a diagnostic or AI tool, so an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable (N/A): This concept applies to standalone AI algorithms. The Luminesse® Pre-Sintered Zirconia Coloring Liquid is a physical material, not an algorithm. Its performance is inherent to its physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Laboratory Measurements / Physical and Chemical Standards: The "ground truth" or reference for the device's characteristics are standardized measurements of physical properties (e.g., general physical form, specific physical form, odor, color, boiling point, density, specific gravity, solubility) and chemical properties (e.g., pH). These are determined in a laboratory setting using established analytical methods, not through expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

• Not Applicable (N/A): This device is a material, not a machine learning model. Therefore, there is no "training set" in the context of AI or data-driven model development.

9. How the ground truth for the training set was established

• Not Applicable (N/A): Since there is no training set as described above, this question is not applicable.

Ask a specific question about this device