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1. Metal free indirect restorations: full crown, inlays, onlays, laminated veneer

MSCB is a block system consisting of a porcelain block cemented to a milling machine specific mandrel. This block/mandrel is designed to be milled in a CAD/CAM milling machine that is programmed to fabricate an indirect restoration. After milling, the restoration can be customized by use of porcelain stain. The composition of this product allows for milling without need to fire in a porcelain furnace.

MSCB-001 system is a feldspathic (glass) porcelain system based on partially crystalline but mostly vitreous materials derived from phyllosilicates such as potash or sodafeldspar, several commercially available fluxes, and various refractive oxides for mechanical enhancement.

This document describes the performance testing for the MSCB-001 device, a porcelain block system used for indirect dental restorations, to demonstrate its substantial equivalence to a predicate device and conformance to ISO 6872:2008.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the total sample size for the test set for each property. However, for Chemical Solubility, Flexural Strength, and Linear Thermal Expansion, three individual measurements are listed for both the MSCB-001 (split into LT A2 and HT A2 translucencies) and the predicate device. This suggests a minimum of 3 samples per translucency/device per test, totaling at least 18 individual tests across the two MSCB-001 variations and the predicate for these properties.

The data provenance is retrospective, as the testing was conducted on samples of the device and compared to a legally marketed predicate device. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This study is a bench performance test comparing physical and chemical properties of a dental material to a recognized international standard (ISO 6872:2008) and a predicate device. Therefore, it does not involve human readers or experts establishing ground truth in the context of clinical interpretation or diagnosis. The "ground truth" for the test set is defined by the objective measurements according to the specified ISO standard.

4. Adjudication Method for the Test Set

Not applicable. As a bench performance test, there is no adjudication process involving human experts to determine a "ground truth" outcome. Results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a bench performance study of a dental material, not a clinical study involving human readers or cases. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense, this is a "standalone" assessment of the device's physical and chemical properties. The performance metrics (chemical solubility, flexural strength, linear thermal expansion, and radioactivity) are inherent to the material itself and are measured objectively, without human intervention in the result determination beyond operating the testing equipment. This is not an "algorithm" in the typical sense of AI, but the device's performance is evaluated independently.

7. Type of Ground Truth Used

The ground truth used is based on objective measurements against established international standards (ISO 6872:2008) for dental ceramics and comparison to the properties of a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in this document, as this is a bench performance test, not a machine learning study.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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