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rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.

rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural tooth.

The provided document is a 510(k) Summary for a dental ceramic device, "rainbow™ LS Pressing." It outlines the device's characteristics and its substantial equivalence to a predicate device, IPS e.max Press and IPS e.max Press Multi. The document describes several non-clinical tests conducted to confirm the device's performance against established standards.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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 the non-clinical tests (bending strength, chemical solubility, linear thermal expansion coefficient, glass transition temperature, or biocompatibility tests).
The country of origin for the submitter, GENOSS Co., Ltd., is Korea. The document does not explicitly state the provenance of the test data (e.g., where the testing was physically conducted). The study appears to be an internal bench testing conducted by the manufacturer, which is typically considered prospective for the purposes of device validation.

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

This section is not applicable as the document describes non-clinical bench testing for material properties and biocompatibility, not studies involving expert adjudication of medical images or clinical outcomes.

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

This section is not applicable. As mentioned above, the study focuses on laboratory testing of material properties, not diagnostic performance 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

This section is not applicable. The device is a dental ceramic material, not an AI-powered diagnostic tool, therefore MRMC studies are not relevant.

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

This section is not applicable. The device is a material, not an algorithm. The non-clinical tests can be considered "standalone" in the sense that they evaluate the material properties directly.

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

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards:

• ISO 6872:2008 for dental ceramic materials (specifically for bending strength and chemical solubility).
• ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-03 for biocompatibility testing.

These standards define the methodologies and acceptable limits for the measured physical and biological properties.

8. The sample size for the training set

This section is not applicable. The context is the evaluation of a dental material, not a machine learning algorithm that requires a training set.

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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