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MIRACLE 98 is intended for manufacturing: - Porcelain to metal fabrication of single units

MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.

The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

Based on the provided 510(k) summary for the "MIRACLE 98" dental casting alloy, the device is a Class II device (Gold-based alloys and precious metal alloys for clinical use). The approval is based on substantial equivalence to a predicate device, Heraeous Kulzer's Jel Bios Pure (K002645), rather than a clinical study with acceptance criteria in the typical sense of a diagnostic or AI device.

Here's the information formatted as requested, with "N/A" where the information is not applicable to this type of device and submission:

Acceptance Criteria and Device Performance for MIRACLE 98 (K031010)

This submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Heraeous Kulzer's Jel Bios Pure, K002645) by comparing material composition and physical/mechanical properties. The "acceptance criteria" are implied by the similarity of these characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Pass" determination is based on the submitter's conclusion that "The main elements and their concentration are almost identical" and "Despite minor differences in the materials, we believe that MIRACLE 98 is a substantially equivalent to Heraeous Kulzer's Jel Bios Pure. These changes do not affect safety or effectiveness." The FDA concurred with this assessment in their letter.

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

• Sample Size: N/A for a clinical or diagnostic test set. The data consists of reported material properties for a specific formulation of the alloy. It is a comparison of two material specifications, not a test on a "test set" of patients or cases.
• Data Provenance: N/A in the typical sense. The properties are likely derived from laboratory testing of the alloy materials, as per ANSI/ADA 5 and ISO 9693 standards. The country of origin for the data is not specified, but the submitter is SB LUCIUS, INC. (Anaheim, CA, USA). The data is not retrospective or prospective in the clinical study context.

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

• Number of Experts: N/A. Ground truth for material properties is established through standardized laboratory testing and chemical analysis, not expert interpretation of results in a clinical setting.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. There is no "test set" requiring expert adjudication. The comparison is based on objective material specifications and test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• MRMC Study: No. This is a material science submission, not a diagnostic imaging or AI device.

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

• Standalone Performance: No. This is a dental material, not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is the scientifically determined chemical composition and physical/mechanical properties of the alloy materials, as measured according to recognized industry standards (ANSI/ADA 5 and ISO 9693).

8. The Sample Size for the Training Set

• Training Set Sample Size: N/A. This is a material device; there is no "training set" in the context of machine learning.

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

• Ground Truth Establishment for Training Set: N/A.

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