Search Results
Found 1 results
510(k) Data Aggregation
(217 days)
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono is used in the manufacture of a dental core through milling by machine followed by sintering.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is milled into core (zirconia substructure) of artificial teeth and then is finally sintered in a furnace to harden the ZrO2.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2, and fitted to the patients as crowns and bridges.
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as anterior crowns, posterior crowns, bridges
rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
The provided text describes the 510(k) premarket notification for the "rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono" dental ceramic. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.
The information provided in the document focuses on the bench testing and biocompatibility testing performed on the device to establish its safety and performance characteristics, comparing it to a predicate device. It does not present a study related to AI or human reader performance/improvement, nor does it describe a ground truth establishment process involving experts or pathology for a test set. This is because the device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or assistive tool.
Therefore, for the aspects related to AI/human reader studies, ground truth establishment, or MRMC studies, the requested information is not applicable to this specific device and the provided document.
Here's the breakdown of the information that is available in the document, framed by the acceptance criteria provided in your prompt, and noting where the requested information is not relevant to this type of device submission:
Device: rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono (Dental Ceramic)
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests, primarily mechanical and chemical, with their acceptance criteria and results.
| No. | Test Item | Acceptance Criteria (Bench Test) | Reported Device Performance (Result) |
|---|---|---|---|
| 1 | Visual | No impurities and No specific changes | Met established specifications |
| 2 | Size | Standard weight <±5% | Met established specifications |
| 3 | Package | No damage | Met established specifications |
| 4 | Uniformity | Uniform after sintering | Met established specifications |
| 5 | Freedom from extraneous materials | Free from extraneous materials | Met established specifications |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | < 1.0 Bq/g (also listed as < 1.0 in comparison table) |
| 7 | Flexural strength | More than 500 MPa | 807.1 MPa (comparison table) / Also "Met established specifications" |
| 8 | Linear thermal expansion | (10.7 ± 0.5) X 10^-6^ K^-1^ | 10.7 (comparison table) / Also "Met established specifications" |
| 9 | Chemical Solubility | Less than 100 µg/cm^2^ | 28.8 µg/cm^2^ (comparison table) / Also "Met established specifications" |
| Biocompatibility Tests | |||
| 1 | Cytotoxicity | None cytotoxicity | Pass |
| 2 | Sensitization | None sensitization | Pass |
| 3 | Irritation or intracutaneous reactivity | None irritation | Pass |
| 4 | Systemic toxicity (acute) | None systemic toxicity | Pass |
| 5 | Genotoxicity | No Toxicity | Pass |
| 6 | Subchronic toxicity | No Toxicity | Pass |
| 7 | Implantation | No Toxicity | Pass |
| 8 | Chronic toxicity | No Toxicity | Pass |
| 9 | Carcinogenicity | No Toxicity | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact sample size for each bench test (e.g., number of blocks tested for flexural strength) is not explicitly stated in the summary document. It states that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the rainbow™ Multi-Layer Block / bright 3-Layer / bright Mono met the established specifications."
- Data Provenance: The tests were conducted to support a submission to the U.S. FDA by Genoss Co., Ltd. from South Korea. The type of data is bench test data and biocompatibility test data, performed on the device material itself. This is not a human clinical study in the sense of retrospective or prospective patient data, but rather laboratory testing of a material.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. As this is a dental material, the "ground truth" for its performance is established through standardized laboratory testing (e.g., ISO 6872 for dental ceramics, ISO 10993 for biocompatibility) and direct physical/chemical measurements by qualified lab personnel. There is no concept of "experts establishing ground truth" in the diagnostic imaging sense for this device.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reviewing images). For physical and chemical material testing, the results are typically quantitative measurements or qualitative observations by laboratory technicians/scientists following established protocols, not subjective assessment requiring 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 is a dental ceramic block, not an AI-powered device or software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Again, this is a physical dental material, not an algorithm or software. As such, the concept of "standalone algorithm performance" does not apply. The device's "performance" is its material properties and safety.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by international standards (e.g., ISO 6872 for dental ceramics, ISO 10993 for biological evaluation of medical devices). These standards define the accepted methodologies and criteria for testing the material's physical, chemical, and biological properties. The results of these tests, conducted according to the standards, serve as the evidence of the device's performance and safety.
8. The Sample Size for the Training Set
- Not Applicable. As this is a physical medical device (dental ceramic) and not an AI/Machine Learning model, there is no concept of a "training set" in the computational sense. The product development and manufacturing process involve R&D and quality control, but not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" for this device, as it is not an AI/ML product.
Ask a specific question about this device
Page 1 of 1