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510(k) Data Aggregation
(169 days)
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blanks are available in various specifications, which are combinations of different dimensions and shapes (Semics, Rods, Blocks and Discs). Furthermore, each specification is available in twenty two (22) color configurations.
This document describes the premarket notification (510(k)) for the "Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established primarily through conformity to ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993 series for biocompatibility. The reported device performance is presented in "Table 1 Results of Non-clinical Tests" and compared against the predicate device in "Table 2 Comparison of Technology Characteristics."
| Item | Acceptance Criteria (typically based on ISO 6872 or ISO 10993 standards) | Reported Device Performance (Nissin Dental Zirconia Blank) |
|---|---|---|
| Radioactivity | Conforms to ISO 6872 (Predicate: <1.0 Bq · g-1) | <5.0 x 10^-3 Bq · g-1 |
| Flexural strength | ≥ 800MPa (Conforms to ISO 6872) | ≥ 800MPa |
| Linear thermal expansion coefficient | (10.5 ± 0.5) x 10^-6 K^-1 (Conforms to ISO 6872) | (10.5 ± 0.5) x 10^-6 K^-1 |
| Chemical solubility | <100 µg · cm^-2 (Conforms to ISO 6872) | <100 µg · cm^-2 |
| Density | 6g/cm3 (Predicate: 6.00g/cm³) | 6g/cm3 |
| Cytotoxicity | No Cytotoxicity (Conforms to ISO 10993-5:2009) | The test article showed none Cytotoxicity. |
| Intracutaneous Reactivity Test | Low reactivity, typically mean score difference < 1.0 (Conforms to ISO 10993-10:2010) | Mean score difference between test sample and vehicle blank is 0.00 and 0.42. |
| Sensitization Test | No sensitization (Conforms to ISO 10993-10:2010) | The test material showed no device of causing sensitization. |
| Systematic Toxicity | No systematic toxicity (Conforms to ISO 10993-11:2006) | The test article showed no systematic toxicity and met the requirement of ISO 10993-11: 2006 standard. |
| Mouse Lymphoma Mutagenesis Assay | Negative for mutagenesis (Conforms to ISO 10993-3:2003) | The results indicated that the extracts of test article did not cause a positive response... and were concluded to be negative. |
| AMES | Non-mutagenic (Conforms to ISO 10993-3:2003) | The test article is considered non-mutagenic in this assay. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of samples for flexural strength, number of animals for biocompatibility tests). The tests are described as non-clinical and conducted to verify design specifications. The provenance of the data is from the manufacturer's testing, likely in China, as the sponsor is Nissin-Metec China Co., Ltd. These are retrospective tests conducted on the device prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For non-clinical material testing and biocompatibility assessments, "ground truth" is typically established by laboratory standards and validated testing protocols (e.g., ISO standards), rather than expert consensus on individual cases. The tests are designed to measure intrinsic material properties and biological reactivity.
4. Adjudication Method for the Test Set
Adjudication methods for test sets are relevant for studies involving human interpretation or subjective assessments. For the non-clinical material and biocompatibility tests described, such methods are not applicable and not mentioned. The results are objective measurements or categorical outcomes (e.g., "no cytotoxicity").
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) systems where human readers interact with AI. The device in question is a dental zirconia blank, a material used for restorations, not an AI system that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an AI algorithm was not done. This device is a material, not an algorithm. The performance tests are for the physical and biological properties of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by objective measurements against recognized international standards (e.g., ISO 6872 for material properties) and validated laboratory protocols for biocompatibility testing (e.g., ISO 10993 series). For instance, flexural strength has a specific numerical value, and cytotoxicity is determined by cell viability assays compared to controls. This is not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical material, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as point 8.
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