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rainbow™ LS Block is a dental ceramic made out of Lithium disilicate. rainbow™ LS Block is milled into cores of teeth and then is fired in a furnace to harden the Li2Si2O3. Then, the core is layered with porcelain to make a finished tooth.

AI/ML Overview

The provided information describes the acceptance criteria and performance data for a dental ceramic device named "rainbow™ LS Block," submitted for 510(k) premarket notification. The study primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device (IPS e.max CAD).

Here's the breakdown of the information that can be extracted from the document, organized according to your requested points.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a table summarizing the performance data, including criteria and results, primarily from bench testing and biocompatibility.

No.	Items	Criteria	Reported Device Performance (Result)	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 (Ames, Micronucleus)	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%	(C-type) W 0.03%, L 3.90%, H 0.21%	ISO 6872
			(Disk type) W 3.42%, L2.36%, H 0.07%	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: < 0.00628 Bq/g	ISO 6872
7	Chemical solubility	Less than 100 $ \mu $g/cm²	Solubility: 12 $ \mu $g/cm²	ISO 6872
8	Flexural strength	More than 100MPa	Average: 370MPa	ISO 6872
9	Linear thermal expansion ($10^{-6}K^{-1}$)	9.95($\pm0.5$) $X 10^{-6}K^{-1}$	Average: 9.95 $X 10^{-6}K^{-1}$	ISO 6872
10	Glass-transition temperature	Less than 579$\pm20$ °C	579 °C	ISO 6872

Study Details

2. Sample size used for the test set and the data provenance

The document indicates that the evaluation was based on bench testing and biocompatibility testing. It does not specify a "test set" in the context of clinical data or images. The sample sizes for the specific tests (e.g., number of samples for flexural strength, chemical solubility) are not explicitly stated in this summary but are implied to be sufficient for compliance with the referenced ISO standards.

The data provenance is from GENOSS Co., Ltd., a company based in Korea (1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea). The study appears to be retrospective in the sense that it's a summary of completed lab tests rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this study. The ground truth for this device (a dental material) is established through physical and chemical property measurements and standardized biological tests, not through expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

This question is not applicable. There is no "test set" requiring human adjudication as this is not a diagnostic AI device or a clinical outcome study. The tests are benchtop measurements guided by 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

This question is not applicable. This is a submission for a dental material (porcelain block) and does not involve AI or human readers for diagnostic interpretation.

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

This question is not applicable. There is no algorithm or AI component mentioned for this device.

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

The ground truth for this device is based on standardized physical, chemical, and biological measurements specified by international standards like ISO 6872 (dental ceramics) and ISO 10993 (biological evaluation of medical devices). For example:

Flexural strength: Measured in MPa against a standard criterion.
Chemical solubility: Measured in $ \mu $g/cm² against a standard criterion.
Biocompatibility: Assessed against criteria like "None cytotoxicity," "None sensitization," etc., based on established biological assays.

8. The sample size for the training set

This question is not applicable. This submission is for a physical dental material, not a machine learning or AI device that would require a "training set."

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

This question is not applicable as there is no training set for this type of device.

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