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EthanZirM Ziconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures. crowns and bridges). EthanZirM Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.

EthanZir™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.

The provided document describes a 510(k) premarket notification for a dental device called "EthanZir™ Zirconia." This document focuses on demonstrating substantial equivalence to a predicate device based on physical and chemical properties, rather than clinical performance or AI-related metrics. Therefore, many of the requested fields regarding acceptance criteria for AI performance, sample sizes for test sets, expert ground truth, MRMC studies, and training set details are not applicable or cannot be extracted from this specific document.

However, I can extract information related to the acceptance criteria for the physical and performance characteristics of the EthanZir™ Zirconia blanks and the nonclinical testing performed to prove these specifications are met.

Here's the information that can be extracted:

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

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "Sintered tests coupled with mechanical bench testing" and "Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted." However, the number of samples or specimens tested is not provided.
• Data Provenance: Not specified regarding country of origin or whether it was retrospective/prospective. The tests were performed by "Besorah Dental Solutions."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This document describes the physical and chemical testing of a material, not the performance of an AI algorithm requiring expert-established ground truth from medical images.

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

• Not Applicable. This document describes material testing, not the evaluation of an AI algorithm with multiple 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:

• No. A MRMC comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic tool.

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

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

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

• The "ground truth" or reference standards for the material testing would be established by controlled laboratory measurements using calibrated equipment and following international standards (ISO 6872:2008 and ISO 13356: 2008).

8. The sample size for the training set:

• Not Applicable. This document does not describe an AI/machine learning model, so there is no training set.

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

• Not Applicable. As there is no AI model, there is no training set ground truth.

Summary of Device Performance Proof:

The document states: "Besorah Dental Solutions performed a series of tests to assess whether the device is safe and effective to use. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. EthanZir™ Zirconia blanks comply with ISO 6872:2008, "Dentistry - Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"."

In essence, the "study" proving the device meets the acceptance criteria consisted of nonclinical laboratory bench testing to measure the physical and chemical properties of the EthanZir™ Zirconia blanks against the specified international standards. No clinical testing or AI performance evaluation was conducted or needed for this type of device submission.

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