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rainbow™ Shade is a dental ceramic made out of colored ZrO2(Y-TZP). rainbow™ Shade is milled into cores of teeth and then is fired in a furnace to harden the ZrO2. Then, the core is layered with porcelain to make a finished tooth.

AI/ML Overview

The provided text describes the performance data for a dental ceramic device named "rainbow™ Shade." It includes acceptance criteria and results from various tests, primarily focusing on biocompatibility and physical properties.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Here are the tables from the document, summarizing the acceptance criteria and the device's performance:

Biocompatibility Testing

No.	Items	Criteria	Result	Standard
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

No.	Items	Criteria	Result	Standard
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% H 0.43%, Ø 0.03%	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	Not Freedom from extraneous materials	ISO 6872
6	Radioactivity	238U Less than 1.0 Bq/g	238U: < 0.000124Bq/g 226Ra: < 0.010Bq/g	ISO 6872
7	Chemical solubility	Less than 100 µg/cm²	Solubility: 0µg/cm²	ISO 6872
8	Flexural strength	More than 800MPa	Average: 913MPa	ISO 6872
9	Linear thermal expansion	10.8(±0.5) X 10⁻⁶K⁻¹	Average: 10.44 X 10⁻⁶K⁻¹	ISO 6872
10	Shipping Test	Result: Pass	Pass	ISTA2011 Integrity Test 3A

Low Temperature Degradation Test

No.	Items	Criteria	Result	Standard
1	Monoclinic phase fraction	Normal: Less than 20% after low temperature degradation: Less than 25%	Normal: 1.26% 134°C, 5 hours: 1.69%	ISO 6872
2	Flexural strength	Less than 20% and more than 800MPa before/ after low temperature degradation	Normal: 850MPa 134°C, 5 hours: 832MPa	ISO 6872

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the individual tests (e.g., number of specimens for flexural strength, number of animals for biocompatibility tests).

Data provenance: The submitter is GENOSS Co., Ltd. located in Gyeonggi-do, Korea. This suggests the testing was likely conducted in Korea or by a laboratory collaborating with the Korean company. The document does not specify if the studies were retrospective or prospective, but based on the nature of bench and biocompatibility testing for a new device submission, these would inherently be prospective studies performed to characterize the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the studies presented are primarily laboratory bench tests and biocompatibility tests, not studies requiring expert interpretation of medical images or clinical outcomes on patients. The "ground truth" for these tests is established by the test methodology and standards themselves (e.g., ISO 10993, ISO 6872).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3. No adjudication method is mentioned or implied for these types of tests. The results are quantitative measurements or qualitative observations by laboratory personnel following established protocols.

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

This section is not applicable. The device "rainbow™ Shade" is a pre-sintered zirconia block for dental restorations, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. As stated above, this is a material science device, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance data presented is derived from established scientific and engineering standards and methodologies. For example:

Biocompatibility tests: Ground truth is defined by the methodologies and interpretations outlined in the ISO 10993 series of standards (e.g., absence of cytotoxicity, sensitization, genotoxicity according to test methods).
Physical and chemical property tests: Ground truth is based on the measurements obtained through standardized test procedures (e.g., ISO 6872 for dental ceramics) and compared against specified numerical criteria (e.g., flexural strength > 800MPa).

8. The sample size for the training set

This section is not applicable. The device is a physical material, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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