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This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges.

CERANUM 90 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 90 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength. durability and color of gold.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CERANUM 90 device, structured to answer your specific questions.

In this 510(k) summary, the device is a dental casting alloy, and the "study" is a comparison to a legally marketed predicate device, not a typical diagnostic or AI-based study. As such, some of your requested categories (like MRMC studies, training set, or expert adjudication for image ground truth) are not applicable.

Acceptance Criteria and Device Performance for CERANUM 90

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Interpretation: For this type of device, "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device (Jel Bios 90). The expectation is that the new device's composition, physical, and mechanical properties are sufficiently similar or superior such that the device is as safe and effective as the predicate. The document highlights that the "main elements and their concentration are almost identical" in composition, and provides a direct comparison of physical/mechanical properties.

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

• Sample Size: Not applicable in the context of a typical clinical test set for a diagnostic device. This submission is based on material property testing and chemical composition analysis of the CERANUM 90 alloy itself, compared to the specifications of the predicate alloy. The quantity of material tested to obtain these properties is not specified but would follow standard material testing protocols (e.g., ANSI/ADA 5 and ISO 9693).
• Data Provenance: The data is generated from testing of the CERANUM 90 alloy, implying a prospective testing approach where the manufacturer performed tests on their own product. The country of origin of the data is not specified, but the manufacturer is SB Lucius, Inc. based in Anaheim, CA, USA, so testing likely occurred in the US or a qualified international lab.

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

• Not applicable. Ground truth, in this context, refers to the accurately measured properties of the alloy, established through standardized material testing methods (ANSI/ADA 5 and ISO 9693), not through expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. There is no human adjudication for material property measurements. The results are quantitative and objective based on defined test methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, which is not the case for a dental casting alloy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This device is a material, not an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this submission consists of:
  • Chemical Composition: Determined by analytical chemistry techniques.
  • Physical and Mechanical Properties: Determined by standardized material testing methods (e.g., melting point, hardness, yield strength, elongation, CTE, density) as specified by ANSI/ADA 5 and ISO 9693.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The material properties are inherent to the alloy's formulation and manufacturing process.

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

• Not applicable. There is no training set. The properties of the CERANUM 90 alloy are established through direct measurement and adherence to manufacturing specifications.

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