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510(k) Data Aggregation
(279 days)
Non-Sterile Zirconia Block (Model: Zircos-E ACE) is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Non-Sterile Zirconia Block (Model name: Zircos-E ACE) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.
The provided document is a 510(k) Summary for a medical device called "Non-Sterile Zirconia Block (Model: Zircos-E ACE)". This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics, rather than a study proving the device meets specific acceptance criteria for diagnostic or clinical performance in the way an AI/software device would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device are not applicable to this submission.
Here's a breakdown of the information available and why certain aspects are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison table (Table 1) between the subject device and the predicate device based on various technical characteristics. It asserts "Equivalence" for each characteristic, indicating that the subject device's performance is expected to be comparable and meet similar standards as the predicate. The "acceptance criteria" here are largely implied by the predicate characteristics and compliance with a standard (ISO 6872).
| ITEM | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| Product Code | EIH | EIH |
| Regulation Number | 872.6660 | 872.6660 |
| Indication for use | Production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. | Production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. |
| Feature | Colored | Colored |
| Shape | Discs | Discs |
| Type and Class per ISO 6872:2015 | Type II Class 5 | Type II Class 5 |
| Sterility | Non-sterile | Non-sterile |
| Chemical Composition | ZrO2 with others | ZrO2 with others |
| Crystal Morphology | Tetragonal | Tetragonal |
| Density | 6.00g/cm³ | 6.00g/cm³ |
| Sintering temperature | $1500\pm50°C$ | $1500\pm50°C$ |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 (Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including Performance Test per ISO 6872 Fourth Edition 2015-06-01, Dentistry Ceramic Materials.) |
| Contact Level | Surface device with permanent contact | Surface device with permanent contact |
| Biocompatibility | Tested for Cytotoxicity, irritation, sensitization, acute systematic toxicity, genotoxicity, no adverse react | Tested for Cytotoxicity, irritation, sensitization, accurate systematic toxicity, genotoxicity, no adverse react. (Specifically: Cytotoxicity per ISO 10993-5:2009; Intracutaneous Reactivity Test per ISO 10993-10:2010; Sensitization Test per ISO 10993-10:2010; Acute Systematic Toxicity per ISO 10993-11:2006). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of clinical or diagnostic performance. For the non-clinical tests (Density, Biocompatibility), the sample sizes used are standard for material testing, but not explicitly detailed in this summary.
- Data Provenance: The tests are non-clinical, conducted according to ISO standards. The origin of the raw material data for these tests is internal to the manufacturer or their testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a material (zirconia block) for dental restorations, not a diagnostic or AI device that requires expert ground truth for its performance evaluation. The "ground truth" for material properties is established by physical and chemical testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is for material testing, not a diagnostic study requiring adjudication of expert interpretations.
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 is a material device, not an AI or software product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a material device, not an AI or software product.
7. The type of ground truth used:
- For the performance characteristics, the "ground truth" is derived from international standard specifications (e.g., ISO 6872 for ceramic materials, ISO 10993 for biocompatibility) and direct quantitative measurements of the material's physical, chemical, and biological properties.
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not Applicable. As above.
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