(88 days)
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Vsmilehappyzir Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
Vsmilehappyzir Dental Zirconia Pre-Shaded Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry -- Ceramic materials.
The provided document is a 510(k) summary for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, and non-clinical performance testing. It does not describe a study involving a device that provides AI/algorithm-based diagnostic or clinical assistance, nor does it involve human readers or image analysis.
Therefore, many of the requested categories are not applicable to the information contained in this document.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures... All tests were verified to meet acceptance criteria." It then lists several tests and their 'Pass' results, indicating acceptance. However, it does not explicitly state the numerical acceptance criteria for each test.
| Test Item | Reported Device Performance |
|---|---|
| Cytotoxicity (ISO 10993-5:2009) | Pass (Non-cytotoxic for 2h, mildly cytotoxic for 24h in filter diffusion; accepted in agar diffusion; no potential toxicity to L-929 cells) |
| Oral Mucosa Irritation (ISO 10993-10:2010) | Pass (No evidence of causing oral mucosa irritation) |
| Delayed Dermal Contact Sensitization (ISO 10993-10:2010) | Pass (No evidence of causing delayed dermal contact sensitization) |
| Subacute Toxicity (ISO 10993-11:2017) | Pass (Did not induce subacute systemic toxicity) |
| Subchronic Toxicity (ISO 10993-11:2017) | Pass (No obvious histopathological difference; normal organ structure) |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Pass (No evidence of causing acute system toxicity) |
| In Vitro Mammalian Cell Gene Mutation (ISO 10993-3:2014) | Pass (Considered non-mutagenic) |
| Micronucleus (ISO 10993-3:2014) | Pass (Did not induce potential genotoxicity) |
| Bacterial Reverse Mutation (ISO 10993-3:2014) | Pass (No potential mutagenesis) |
| Muscle Implant (ISO 10993-6:2016) | Pass (Did not induce local effects after implantation) |
| Radioactivity, Flexural strength, Chemical solubility, Linear thermal expansion coefficient, Freedom from extraneous materials, Uniformity, Shrinkage factor, Pre-sintered density, Sintered density, Fracture toughness | "Very similar to predicate device," and confirmed "met its specifications" and "acceptance criteria." Specific numerical values for these tests and their acceptance criteria are not provided in this summary. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing" and "Biocompatibility testing." For biocompatibility, it indicates specific animal models where applicable (e.g., Syrian hamsters for oral mucosa irritation, guinea pig for dermal sensitization, rats for subacute/subchronic toxicity, ICR mice for acute systemic toxicity/genotoxicity, rabbits for muscle implant). However, it does not specify the number of samples or animals used for each test. The results are reported as "Pass," implying sufficient sample sizes were used to meet the standard's requirements.
Data provenance: The testing was performed according to international ISO standards (e.g., ISO 6872:2015, ISO 10993 series). The submitter is a Chinese company (Hunan Vsmile Biotechnology Co., Ltd.). This is non-clinical lab testing, not human patient data.
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. This is not a study involving expert assessment of images or clinical cases to establish ground truth. The "ground truth" for these tests is defined by the objective measurement of physical and biological properties against established ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as this is not a study involving human interpretation or consensus.
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 document describes material science testing for dental zirconia blanks, not an AI-assisted diagnostic or clinical effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes material science testing for dental zirconia blanks, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device performance is the adherence to specifications derived from international standards (ISO 6872:2015 for ceramic materials, ISO 10993 series for biocompatibility). These are objective, measurable physical and biological properties.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this type of 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.