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The Origin Zirconia Dental Material is an integrated system of dental ceramic which supports dental restorations and which are milled into prosthetic devices such as Crowns, Bridges, and Copings for partial and fully edentulous patients. The material can be milled into a variety of customized dental restorations to meet the specific needs of individual dental patient is named by a physician or dentists written prescription specifying the type of restoration to be produced.

Origin Zirconia is intended to be used as a biocompatible material to be milled into precise customized dental restoration units for either crowns, copings or bridges which may be further processed by the addition of ceramic layering to create aesthetic lifelike restorations.

Origin Zirconia is intended to be used as prescribed by a qualified and licensed physician or dentist by a written prescription which names the patient for which each individual dental restoration is to be produced.

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This document is a 510(k) premarket notification acceptance letter from the FDA for a dental material named "Origin Zirconia." It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics that would be typically associated with AI/ML devices.

The information provided is primarily related to the regulatory clearance of a dental material, not a software algorithm or an AI device. Therefore, most of the requested fields regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, standalone performance, training sets, ground truth establishment) are not applicable to the content of this document.

However, I can extract the general "indications for use" as this represents the intended purpose and, implicitly, the minimum functional requirements for the dental material.

Here's the breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: The document describes the "Indications for Use" for the Origin Zirconia Dental Material. These act as the functional acceptance criteria for the material itself. It states it should support dental restorations and be milled into prosthetic devices (Crowns, Bridges, Copings). It also needs to be biocompatible and customizable for individual patients under prescription. The 510(k) clearance implies that the device meets the safety and effectiveness standards comparable to a predicate device for these uses.

• Reported Device Performance: The document does not provide specific quantitative performance metrics (e.g., strength, durability, fit accuracy) in a table. It only states that the device is "substantially equivalent" to legally marketed predicate devices. The FDA's clearance is based on the material meeting these functional indications for use and demonstrating substantial equivalence, which would imply performance similar to existing devices on the market for these applications.

  • Table (Conceptual, based on indications):

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

• Information Not Present: This document does not mention any test set sample sizes or data provenance as it pertains to a material rather than an algorithm.

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)

• Information Not Present: This concept is not applicable to the clearance of a dental material. The "ground truth" for a material would typically be its physical and chemical properties and performance characteristics, assessed through standardized lab tests and potentially clinical trials, rather than expert interpretation of data.

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

• Information Not Present: This is not applicable to the clearance of a dental material.

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

• Information Not Present: This is not applicable as the device is a dental material, not an AI system.

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

• Information Not Present: This is not applicable as the device is a dental material, not an AI system.

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

• Information Not Present: The document implies that the ground truth for approving "Origin Zirconia" would relate to its physical properties, biocompatibility, and functional performance (e.g., strength, wear resistance, fit), typically assessed through laboratory testing and comparison to established predicate devices and standards for dental materials. This is not explicitly detailed in the letter.

8. The sample size for the training set

• Information Not Present: This is not applicable as the device is a dental material, not an AI system.

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

• Information Not Present: This is not applicable as the device is a dental material, not an AI system.

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