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510(k) Data Aggregation
(301 days)
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). These blanks are fabricated into dental core (zirconia substructure) of crowns and bridges. The core can be used as final prosthesis by itself or can be layered with porcelain. rainbow™ Shine 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™ Shine 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 single crowns, bridges including from 2-bridge to 16bridge(full arch). It is also supplied in six different colors (A0, A0.5, A1, A2, A3, A4) for each shapes. rainbow™ Shine 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.
This document is a 510(k) summary for the rainbow™ Shine dental ceramic. The document asserts the device's substantial equivalence to a predicate device based on non-clinical testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Reported Predicate Performance (rainbow™ High Shine) | Comparison to Acceptance Criteria |
|---|---|---|---|---|
| Bending Strength (Flexural Strength) | > 500 MPa (for Class 5 dental ceramics) | 865 MPa | 706 MPa | Meets and exceeds |
| Sintering Density | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 6 g/cm³ | 6 g/cm³ | Assumed to meet |
| Radioactivity | < 1.0 (Bq/g) | < 1.0 Bq/g | < 1.0 Bq/g | Meets |
| Linear thermal expansion (10⁻⁶ K⁻¹) | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 10.4 (±0.5) | 10.4 (±0.5) | Assumed to meet |
| Chemical Solubility | < 100 µg/cm² (for Class 6 dental ceramics, though rainbow™ Shine is Class 5. This appears to be a slight discrepancy in the document's wording but implies a stringent standard) | 0 µg/cm² | 3 µg/cm² | Meets and exceeds |
| Biocompatibility | ISO 10993-1:2009 standards (Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Genotoxicity) | Biocompatible | Biocompatible | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (bending strength, chemical solubility, etc.). It only mentions that "Non-clinical device testing was conducted to confirm the performance of the subject device" and "Bench tests for performance comparison...includes the following testing." The data provenance is not specified, but since Genoss Co., Ltd. is based in Korea and the submission is to the FDA, it is likely the testing was conducted in a laboratory setting, potentially in Korea or by a contracted lab. The study is retrospective in nature, presenting the results of pre-market testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical, benchtop tests (e.g., material property measurements) and biocompatibility assessments, which are performed in a laboratory settings and do not directly involve human experts in establishing a "ground truth" for clinical outcomes in the same way an imaging study might. The "ground truth" for these tests are the established scientific and engineering principles and the recognized consensus standards (like ISO 6872:2008 and ISO 10993-1:2009).
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are non-clinical and do not involve human interpretation or subjective assessment that would require an adjudication method.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a dental ceramic block, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (bending strength, chemical solubility, etc.), the "ground truth" is defined by the recognized consensus standards, specifically ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993-1:2009 (Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process). These standards define the methods for testing and the acceptable ranges for the performance characteristics of dental ceramic materials.
8. The Sample Size for the Training Set
This information is not applicable. This device is a dental ceramic and does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(191 days)
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shine is milled into cores of artificial teeth and then is finally sintered in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.
The provided document is a 510(k) summary for a dental ceramic device named "rainbow™ Shine". It details the device's characteristics and compares it to a predicate device, "RAINBOW BLOCK", to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate RAINBOW BLOCK / ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Comparison Status / Notes |
|---|---|---|---|
| Device Classification | Type II - Class 6 (for predicate) | Type II - Class 5 | The subject device and predicate device satisfy dental ceramic classification requirements by ISO 6872:2008. The difference in class and bending strength is noted, with rainbow™ Shine having a lower bending strength due to complete Y2O3 stabilization for higher translucency. Despite this, it meets the ISO standard. |
| Bending Strength (Flexural strength) | 1144 MPa (for predicate) / > 500 MPa (ISO 6872:2008 for Class 5) | 706 MPa | Bending strength for rainbow™ Shine is higher than required by ISO 6872:2008 for Class 5 dental ceramics (> 500 MPa), despite being lower than the predicate. |
| Sintering Density (g/cm³) | 6.00-6.04 (for predicate) | 6 | Same (within range of predicate and likely meets ISO, though specific ISO density not stated) |
| Radioactivity (Bq/g) | < 1.0 Bq/g (for predicate) | < 1.0 Bq/g | Same |
| Chemical Solubility (µg/cm²) | 14.47 (for predicate) / < 2000 µg/cm² (ISO 6872:2008 for Class 5) | 3 | Chemical solubility for rainbow™ Shine satisfies the requirement by ISO 6872:2008 for Class 5 dental ceramics (< 2000 µg/cm²), and is lower/better than the predicate. |
| Biocompatibility | Biocompatible (for predicate) | Biocompatible | Same, confirmed by ISO 10993 testing. |
| Materials | Tosoh Powder (for predicate) | Tosoh Powder | Same base material, with slight differences in Y2O3 percentages and trace elements (SiO2, Fe2O3, Na2O, Er2O3) used as colorants, which reportedly have no material effects on biocompatibility. |
| Form | Preformed block (for predicate) | Preformed block | Same |
| Sterilization | Non-sterile (for predicate) | Non-sterile | Same |
| Indication for use | As described for predicate | As described for subject device | Same |
| Use | Prescription (for predicate) | Prescription | Same |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for the non-clinical bench tests (bending strength, sintering density, radioactivity, chemical solubility). It only states that "Non-clinical device testing was conducted to confirm the performance of the subject device." The data provenance is implied to be from the manufacturer (GENOSS Co., Ltd.) through their conducted tests, but the country of origin of the testing facilities or whether the data is retrospective or prospective is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The ground truth for the performance criteria is established by recognized standards (ISO 6872:2008), not through expert consensus on individual cases.
4. Adjudication method for the test set
Not applicable. The tests are bench tests against a recognized standard, not clinical studies requiring adjudication of diagnostic outcomes.
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 science and biocompatibility assessment of a medical device (dental ceramic), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. The "standalone" performance here relates to the inherent material properties and biocompatibility of the ceramic block itself, which were tested via bench and biocompatibility tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating the device's performance is:
- Recognized consensus standards: Specifically, ISO 6872:2008 (dentistry - ceramic materials) for physical properties like bending strength and chemical solubility, and ISO 10993-1:2009 (Biological evaluation of medical device) for biocompatibility.
- Comparison to a legally marketed predicate device: The characteristics of the RAINBOW BLOCK predicate device also serve as a reference for comparison.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no concept of a "training set" in the context of this device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device. The "ground truth" for the device's properties is established through standardized testing methodologies as defined by ISO standards.
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