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

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The provided text describes a 510(k) premarket notification for a dental casting alloy named CERANUM 50. It aims to demonstrate substantial equivalence to a predicate device, DEGUBOND 4.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for CERANUM 50 are based on demonstrating substantial equivalence in composition and physical/mechanical properties to the predicate device, DEGUBOND 4, as defined by ANSI/ADA 5 and ISO 9693 standards. The device's performance is reported in direct comparison to the predicate device.

Study Proving Acceptance:
The study that proves the device meets the acceptance criteria is a comparative study against the legally marketed predicate device, DEGUBOND 4. This comparison is conducted by evaluating the composition (by weight %) and several physical and mechanical properties according to recognized standards (ANSI/ADA 5 and ISO 9693). The "Discussion" section explicitly states, "Since the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar." The "Conclusion" further asserts that "The main elements and their concentration are almost identical" and "Despite minor differences in the materials, we believe that CERAUM 50 is a substantially equivalent to DEGUSSA AG's DEGUBOND 4. These changes do not affect safety or effectiveness."

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

• Sample Size for Test Set: The document does not specify the sample size for the individual tests (e.g., how many samples were tested for hardness, melting point, etc.). It only presents single values for each property.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only mentions that the tests were conducted "as in ANSI/ADA 5 and ISO 9693," which are international standards.

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

This type of study does not involve expert-established ground truth in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" here is the measured properties of the materials themselves, evaluated against established material standards and the properties of a known predicate device. Therefore, information about the number or qualifications of experts for ground truth establishment is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Not applicable. This is a material testing study, not a clinical study requiring human adjudication of results. The "adjudication" is inherent in the measurement methods defined by the standards (ANSI/ADA 5 and ISO 9693).

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

No, an MRMC comparative effectiveness study was not done. This study is a material science comparison, not a clinical performance study involving human readers and interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a material science assessment, not an algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measured physicochemical and mechanical properties of the CERANUM 50 alloy, compared directly against the known properties of the legally marketed predicate device (DEGUBOND 4) and against the specifications outlined in relevant industry standards (ANSI/ADA 5 and ISO 9693). There is no "expert consensus," "pathology," or "outcomes data" in the typical medical device sense. The ground truth for the comparison is the measured data for both the new and predicate device.

8. The Sample Size for the Training Set

Not applicable. This type of material comparison study does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this type of material comparison study.

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