Search Results
Found 1 results
510(k) Data Aggregation
(124 days)
rainbow™ Trans is used in the manufacture of a dental core.
rainbow™ Trans is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Trans 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 describes the predicate device and the new device (rainbow™ Trans) being submitted for 510(k) premarket notification. The study provided is a comparison of technical characteristics and performance data against established standards, rather than a clinical study involving human subjects or AI performance. Therefore, many of the requested categories (sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract the acceptance criteria and reported device performance from the "Performance Data" section.
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Item | Acceptance Criteria | Reported Device Performance | Standard |
|---|---|---|---|---|
| Biocompatibility Testing | ||||
| 1 | Cytotoxicity | None cytotoxicity | None cytotoxicity | ISO 10993-5 |
| 2 | Sensitization (Local Lymph Node Assay) | None sensitization | None sensitization | ISO 10993-10 |
| 3 | Oral mucosa irritation | Less than stimulus threshold | Minimal irritation | ISO 10993-10 |
| 4 | Acute systemic toxicity | None acute Systemic toxicity | None acute Systemic toxicity | ISO 10993-11 |
| 5 | Genotoxicity | None genotoxicity | None genotoxicity | ISO 10993-3 |
| Performance Bench Testing | ||||
| 1 | Visual | No impurities and No specific changes | No impurities and No specific changes | ISO 6872 |
| 2 | Size | Size error of; Standard Size < ±5% | Size error of; Standard Size < ±5% | ISO 6872 |
| 3 | Package | No damage | No damage | ISO 6872 |
| 4 | Uniformity | Uniform | Uniform | ISO 6872 |
| 5 | Freedom from extraneous materials | Not Freedom from extraneous materials (This appears to be a typo in the document; it likely means "Freedom from extraneous materials" with a positive outcome) | Not Freedom from extraneous materials (Assuming this also refers to a positive outcome in context) | ISO 6872 |
| 6 | Radioactivity | 238U Less than 1.0 Bq/g | 238U: < 0.000124 Bq/g, 226Ra: < 0.010 Bq/g | ISO 6872 |
| 7 | Chemical solubility | Less than 100 µg/cm² | Solubility: 9 µg/cm² | ISO 6872 |
| 8 | Flexural strength | More than 800 MPa | Average: 902 MPa | ISO 6872 |
| 9 | Linear thermal expansion | 10.8 (±0.5) x 10⁻⁶ K⁻¹ | Average: 10.8 x 10⁻⁶ K⁻¹ | ISO 6872 |
| 10 | Shipping Test | Result: Pass | Pass | ISTA2011 Integrity Test 3A |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document mentions "Biocompatibility testing on the proposed rainbow™ Trans has been completed" and "The proposed rainbow™ Trans was evaluated using the following performance bench testing." Typically, these types of tests involve a statistically sufficient number of samples as determined by the specific ISO standards, but the exact count is not given.
- Data Provenance: The tests were conducted by GENOSS Co., Ltd. (based in Gyeonggi-do, Korea). The data is from laboratory bench testing rather than clinical data from a specific country or patient population; therefore, it is prospective in the sense that the tests were performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this involves laboratory bench testing and biocompatibility assessments against quantitative standards, not expert interpretation of clinical cases.
4. Adjudication method for the test set:
- Not applicable. The tests are against predefined quantitative criteria from ISO 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 is not a study of an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Ground Truth: Quantitative and qualitative specifications defined by internationally recognized consensus standards, specifically ISO 10993 series for biocompatibility and ISO 6872 for dental ceramics. The "ground truth" for the shipping test was the ISTA2011 Integrity Test 3A.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Ask a specific question about this device
Page 1 of 1