(114 days)
The product is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns,facings, and veneers.
The product is casted by cold isostatic cool pressuring and processed by pre-sintering with zirconia powder as the material.
There are two product families within our subject device - HS Series and HTIII Series, which are quite similar in Physical & Mechanical Properties. And the two product families all boast two shapes - the ones without steps and the ones with 2 steps, and eight sizes - 98×10mm for the ones without steps and 98×12mm, 98×14mm, 98×16mm, 98×18mm, 98×20mm, 98×22mm and 98×25mm for the ones with 2 steps.
This document is a 510(k) premarket notification for an All-Ceramic Zirconia Block, a type of dental material. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of a new diagnostic algorithm.
Here's a breakdown of the provided information, focusing on how the device demonstrates compliance with standards:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from the characteristics of the predicate device and relevant international standards for dental materials. The study proves the device meets these criteria by demonstrating similar properties to the predicate and compliance with specified ISO standards.
| Characteristic | Predicate Device (Acceptance Criteria) | Subject Device (Reported Performance) | Met? |
|---|---|---|---|
| Indication for Use | Production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. | Indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. | Yes |
| Material of Construction | Zirconia Powder | Zirconia Powder | Yes |
| Crystal Morphology | Tetragonal | HS&HTIII: Tetragonal | Yes |
| Color | White | HS&HTIII: White | Yes |
| Density (pre sintering) | 3.10 g/cm³ | HS: 3.10 g/cm³, HTIII: 3.30 g/cm³ | Mostly Yes (HTIII slightly different, but likely within acceptable range for substantial equivalence given the overall similar properties) |
| Density (post sintering) | 6.05 g/cm³ | HS&HTIII: 6.0-6.1 g/cm³ | Yes |
| Fracture Toughness (pre sintering) | 55 Mpa | HS: 53.48 Mpa, HTIII: 54.9 Mpa | Yes (Very close to predicate) |
| Fracture Toughness (post sintering) | 1200 Mpa | HS&HTIII: 1250 Mpa | Yes (Subject device is slightly higher, indicating potentially better performance, which supports equivalence or superiority from a safety/effectiveness perspective for this property) |
| Elastic modulus (post sintering) | 210 Gpa | HS&HTIII: 210 Gpa | Yes |
| Sintering temperature | 1480°C | HS: 1500°C, HTIII: 1450°C | Mostly Yes (Both within a reasonable range of the predicate; specific temperature depends on material formulation and desired properties) |
| Shrinkage (pre sintering) | 20.00% | HS: 0.3%, HTIII: 1.02% | No, there appears to be a significant discrepancy here. The predicate's pre-sintering shrinkage is 20%, while the subject device lists 0.3% and 1.02%. This might indicate a misunderstanding of the table field or different measurement methodologies, or it could be a notable difference. However, the subsequent post-sintering shrinkage percentage for the subject device (HS: 20%, HTIII: 18.4%) is closer to the predicate's post-sintering shrinkage (22.00% as listed under "Shrinkage (post sintering)" for the predicate). This discrepancy needs clarification for a full assessment. |
| Shrinkage (post sintering) | 22.00% | HS: 20%, HTIII: 18.4% | Yes (Comparable to predicate) |
| Porosity | 0% | HS & HTIII: 0% | Yes |
| Shapes & Sizes | 7 different product families of shapes and a multitude of different sizes | 2 product families, 2 shapes and 8 sizes | No (Acknowledged difference, but stated not to affect core usage/substantial equivalence) |
| Effectiveness | Tested According to ISO 6872 | Tested According to ISO 6872 | Yes |
| Safety | Evaluated according to ISO 10993-1 | Tested According to ISO 10993-3, -5, -10, -11. | Yes (Subject device tested to more specific parts of ISO 10993, demonstrating compliance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for specific tests (e.g., how many blocks were tested for density or fracture toughness). This is common for material testing where results are often presented as mean values from a batch or specific number of samples required by the standard.
- Data Provenance: The document states "The subject device was tested to evaluate its safety and effectiveness according to the following standards". It doesn't specify the country of origin for the testing data, but the manufacturer is based in Rizhao City, Shandong Province, China. The tests are non-clinical (laboratory-based), not clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material science characterization and equivalence study, not a study involving human expert interpretation of data or images to establish ground truth for a diagnostic device. The "ground truth" here is defined by the physical, mechanical, and biological properties measured and compared against established international standards and the predicate device's characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving human interpretation or adjudication. The "adjudication" is done through direct measurement and comparison with predefined specifications and standards.
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 pertains to an All-Ceramic Zirconia Block, a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to an All-Ceramic Zirconia Block, a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests (biocompatibility and effectiveness parameters like density, fracture toughness) are the specifications and requirements defined by the referenced international standards (ISO 6872, ISO 10993 series) and the characteristics of the predicate device. Compliance with these standards and similarity to the predicate establishes the "truth" of the device's acceptable performance for regulatory purposes.
8. The sample size for the training set
Not applicable. This is a material characterization study for substantial equivalence, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a material characterization study for substantial equivalence, not a machine learning model.
§ 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.