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CERANUM 82 is intended for manufacturing:

• Single Crown -
• Bridges -
• Implant superstructures

CERANUM 82 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 82 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.

The provided text describes a 510(k) premarket notification for a dental casting alloy, Ceranum 82, and its substantial equivalence to a predicate device, Metalor's V-Supragold. This is a material comparison, not a medical device involving AI, image analysis, or clinical performance studies in the way the request implies. Therefore, many of the requested fields are not applicable.

Here's the relevant information extracted and presented:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device, Metalor's V-Supragold, and relevant industry standards (ANSI/ADA 5 and ISO 9693). The device (Ceranum 82) meets these criteria by demonstrating comparable physical and mechanical properties within acceptable ranges. The "acceptance" is based on showing substantial equivalence rather than meeting strict predefined thresholds for a new clinical outcome.

Note: The discussion explicitly states, "The main elements and their concentration are almost identical," and "Despite minor differences in the materials, we believe that CERAUM 82 is a substantially equivalent to Metalor's V-Supragold. These changes do not affect safety or effectiveness." This implies that the observed differences are deemed acceptable within the context of substantial equivalence.

Regarding the Study:

The study proving the device meets the acceptance criteria is a bench testing/laboratory comparison study against a legally marketed predicate device, using established industry standards.

• Test methods applied: ANSI/ADA 5 and ISO 9693.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material characterization rather than a clinical study with patients or a dataset for an algorithm. The "test set" would refer to the samples of the Ceranum 82 alloy that underwent the physical and chemical tests. The document does not specify the number of material samples tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a material science characterization; ground truth is established by standardized measurements of chemical composition and physical properties rather than expert consensus on interpretive data.

4. Adjudication method for the test set: Not applicable. Material properties are measured, not adjudicated by human readers.

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: Not applicable. This document pertains to a dental alloy, not an AI-powered diagnostic or assistive device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device involved standardized laboratory measurements of chemical composition and physical/mechanical properties in accordance with industry standards (ANSI/ADA 5 and ISO 9693), and comparison to the known properties of a predicate device.

8. The sample size for the training set: Not applicable. This is not an AI or machine learning device.

9. How the ground truth for the training set was established: Not applicable. No training set is involved for this type of device submission.

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