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The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.

JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the implantgrade polymer, PEEK-OPTIMA® LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The discs are provided either with or without a step.

Here's an analysis of the provided text regarding the Juvora Dental Disc's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in the non-clinical performance data or the biocompatibility testing. It only mentions "testing is performed in compliance with applicable clauses" and "JUVORA™ Dental Disc has been assessed in terms of biocompatibility."

The data provenance is not specified beyond the company, Juvora (located in the UK), conducting the tests. It is implied these were internal studies conducted specifically for this 510(k) submission.

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

This information is not provided in the given text. The studies appear to be laboratory-based non-clinical performance and biocompatibility testing, which typically rely on standardized methods and measurements rather than expert consensus on a "ground truth" in the same way clinical studies might.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The studies described are non-clinical, laboratory-based tests for material properties and biocompatibility, not studies involving human interpretation or subjective assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The Juvora Dental Disc is a material for dental prostheses, not an AI-powered diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. As explained above, this device is a material, not an algorithm.

7. The Type of Ground Truth Used

For non-clinical performance data (strength): The "ground truth" is established by the specified standards and their methodologies, such as ISO 20795-1. The material's properties (e.g., flexural strength, water sorption) are measured and compared against the limits defined by these international standards.

For biocompatibility testing: The "ground truth" is established by the methods and criteria outlined in ISO 10993-1:2009 and ISO 7405:2008. This involves specific biological endpoints (cytotoxicity, systemic toxicity, irritation, etc.) which, when tested, determine if the material elicits an unacceptable biological response.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The Juvora Dental Disc is a physical material, not a machine learning model, so there is no "training set" in this context.

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

This information is not provided and not applicable for the same reason as in point 8.

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