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GenesisZr® 4Y+(ST1100) Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.

GenesisZr® 4Y+ (ST1100) Zirconia are disc and block 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 a crown, bridge or coping.

The provided text is a 510(k) Premarket Notification for a dental device, GenesisZr® 4Y+(ST1100) Zirconia. This document focuses on demonstrating substantial equivalence to a predicate device based on physical, chemical, and performance characteristics, rather than clinical efficacy studies. Therefore, it does not describe an acceptance criteria table, a study proving device performance in a clinical setting, or details related to AI/human-in-the-loop studies.

Instead, the document details nonclinical testing to demonstrate the device meets established specifications and international standards for dental ceramic materials.

Here's an analysis of the provided text based on your request, highlighting what is present and what is absent:

Device: GenesisZr® 4Y+(ST1100) Zirconia

The provided document describes a premarket notification (510(k)) for a dental material, specifically zirconia blanks used for dental restorations. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, primarily through nonclinical testing, material characterization, and adherence to recognized standards. It typically does not involve clinical studies or human-in-the-loop performance evaluations as would be expected for a diagnostic AI device.

Therefore, the requested information regarding acceptance criteria for clinical performance, sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance for an AI device is not applicable to this document.

However, I can extract information related to the device's physical and performance characteristics, which serve as its "acceptance criteria" in the context of this 510(k) submission, and how its performance against these criteria was "proven" through nonclinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its physical and chemical properties, as measured through laboratory testing, and its compliance with relevant ISO standards.

Note: The "acceptance criteria" here are largely derived from the requirements of the cited ISO standards (ISO 6872:2015 "Dentistry - Ceramic materials" and ISO 13356:2015 "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)"). The device's reported performance data are directly compared against these standards to demonstrate compliance.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of specimens tested) for each physical and chemical property test. It states that "United Dental Resources Corporation performed a series of tests" and that "sintered tests coupled with mechanical bench testing confirmed that the device meets specifications."
• Data Provenance: The data is generated from nonclinical bench testing conducted by the manufacturer, United Dental Resources Corporation. The provenance is internal to the company for the purpose of this regulatory submission. The document does not mention the country of origin of the raw data beyond the company's address (University Park, Illinois 60484, USA). The testing is retrospective in the sense that it was completed prior to the 510(k) submission, but it's not retrospective clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This submission is for a material device, not an AI diagnostic tool or a device requiring subjective interpretation by human experts to establish ground truth for performance. The "ground truth" for this device lies in its measurable physical and chemical properties and compliance with engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human readers or subjective interpretations, there is no need for an adjudication method. Performance is determined by objective laboratory measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is relevant for diagnostic imaging devices or AI tools where human reader performance is a key metric. For a dental ceramic material, MRMC studies are not applicable. The document states: "Clinical tests have not been performed."

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

• No. This term is only relevant for software/AI devices. The GenesisZr® 4Y+(ST1100) Zirconia is a physical material blank.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on objective measurements of physical and chemical properties against established international standards (ISO 6872:2015 and ISO 13356:2015). This is a form of engineering/material specification compliance. It is not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

• Not Applicable. This is not a machine learning or AI device, so there is no "training set." The device is a manufactured product with defined material properties.

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

• Not Applicable. See point 8.

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