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Refractron Technologies Corporation Bisque Zirconia Blanks (Type BYZ), are indicated for use as a substructure for ceramic dental restorations.

Refractron Porcelain Powder Blanks are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine-grained, bisque body allows intricate shapes to be machined with specified tolerances. Refractron Technologies Corporation Blanks (exactly Zircar Zirconia, Inc. Blanks) are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. Products are either porous or dense. Porous blanks can then be sintered to full density and strength. Dense blanks do not need a final heat treatment and are therefore ready for veneering immediately after machining. All appliances are for the sole use of the particular patient only. At the dental lab (Refractron's customer that processes the blanks) a metal chuck is glued on the end of the blank that holds it in the CAD/CAM machine which is used to machine the final dental restoration. At the completion of the machining steps, the dental restoration is fired, i.e. sintered, in the oven to harden the ZrQ2.

The provided document is a 510(k) premarket notification for a medical device, specifically Refractron Bisque Zirconia Blanks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.

The document explicitly states: "The Refractron Bisque Zirconia Blank is substantially equivalent in function and intended use to the Zircar Zirconia, Inc. Bisque Zirconia Blanks - K081850." and "It has been shown in this pre-market notification submission, that the differences between the Refractron Porcelain Powder Blanks and the Zirconia Blanks do not raise any questions regarding their safety and effectiveness. They are, as explained below, the same product."

Therefore, the information typically requested in your prompt (such as acceptance criteria, reported device performance metrics from a study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not present in this type of regulatory submission because it's not a de novo clearance or a PMA where such detailed performance studies are usually required. The "study" here is essentially a comparison to a predicate device to show identical or very similar characteristics and performance.

Here's a breakdown based on the information that is available in the provided text:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: The primary "acceptance criterion" for a 510(k) is substantial equivalence to a predicate device. This means demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document asserts that "The Refractron Porcelain Powder Blanks, as designed and manufactured, are as exactly safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referred predicate device. They are in fact, one-in-the same." No specific performance metrics (e.g., strength, durability, fit) are reported in a quantifiable table within these pages; rather, it's a qualitative statement of equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This document does not describe a clinical or performance study with a test set of data. The submission relies on demonstrating the material properties and manufacturing process are equivalent to the predicate, which itself would have undergone testing previously.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. As there is no clinical or performance test set described, there are no experts establishing ground truth for such a set within this document. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No test set or need for adjudication is mentioned.

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 device is a dental material, not an AI-assisted diagnostic tool, so MRMC studies are irrelevant.

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

• Not Applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" implicitly relied upon is the established safety and effectiveness profile of the predicate device (Zircar Zirconia, Inc. Bisque Zirconia Blanks - K081850), as determined by previous FDA clearance processes. The current submission argues that the Refractron blanks are identical or sufficiently similar to this predicate, meaning no new safety or effectiveness concerns are raised.

8. The sample size for the training set:

• Not Applicable. No training set for a machine learning algorithm is involved.

9. How the ground truth for the training set was established:

• Not Applicable. No training set for a machine learning algorithm is involved.

In summary, this document is a 510(k) Premarket Notification focused on demonstrating substantial equivalence to an existing predicate device rather than presenting performance data from a novel study against specific acceptance criteria.

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