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The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:

i) full and partial removable dentures and implant overdentures.

ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental disc, outlining its regulatory status and intended use. It does not include details on performance studies, sample sizes, ground truth establishment, or expert qualifications.

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The JUVORA™ Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:

i) full and partial removable dentures and implant overdentures.

ii) copings, substructures (cemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the polymer, PEEK-OPTIMA™ LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The disc is provided non-sterile, without any accessories, and are single use.

The JUVORA™ Dental Discs are provided in a variety of sizes:

Ø 95 x 16 mm Ø 95 x 20 mm Ø 98 x 16 mm Ø 98 x 18 mm Ø 98 x 20 mm Ø 98 x 22 mm Ø 98 x 25 mm Ø 98 x 30 mm Ø 101 x 13 mm

Ø 101 x 20 mm

The provided text describes a 510(k) premarket notification for the Juvora Dental Disc, and evaluates its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device and therefore primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device.

Unfortunately, this type of regulatory document does not typically include the detailed information required to answer your questions about acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert-driven studies (like MRMC or standalone AI performance). These elements are much more common in publications and regulatory filings for AI/ML-driven diagnostic devices, especially those that provide clinical insights or automate diagnostic tasks.

The Juvora Dental Disc is a physical dental material (a thermoplastic disc) used for manufacturing dental prostheses (dentures, crowns, bridgework). The "performance" in this context refers to its physical and biocompatibility properties, not the performance of an AI algorithm.

However, I can extract the information that is present and explain why other information is not available in this document.

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

The document compares the new device (K160918) to its predicate device (K132725) and a reference device (K133608) based on various material properties. While explicit "acceptance criteria" for each parameter aren't stated as numeric thresholds (e.g., "must be > X MPa"), the implicitly accepted performance is "substantially equivalent" to (or matching) the predicate device, or meeting relevant ISO standards.

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

• Sample Size: Not specified in the document. The physical and mechanical testing (e.g., flexural strength, water absorption, shear bond) would have involved multiple samples, but the exact number for each test is not provided in this regulatory summary.
• Data Provenance: The tests were conducted to international ISO standards (e.g., ISO 10477, ISO 20795, ISO 6872, ISO TR 11405, ISO 62, ISO 10993). This implies standard laboratory testing, likely by the manufacturer or a contracted lab. The country of origin of the data is not specified, but the manufacturer is Juvora, Ltd. based in the UK. The studies are prospective in nature, as they involve testing newly manufactured materials according to established protocols.

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)

This question is not applicable to this device submission. This is a material science and biocompatibility submission, not an AI/ML diagnostic device. "Ground truth" in this context refers to the measured physical and chemical properties of the material, not expert clinical diagnoses. The "truth" is established by adhering to the specified ISO testing standards and methodologies.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building among multiple human reviewers for tasks like image interpretation or clinical diagnosis. This document pertains to material property testing, where the "truth" is derived from standardized physical measurements, not human interpretation.

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. MRMC studies are specific to evaluating AI/ML systems in diagnostic imaging or similar contexts where human readers interact with AI assistance. This 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

Not applicable. This question relates to the performance of an AI algorithm. The device is a physical dental material.

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

The "ground truth" for this device's evaluation is primarily:

• Physical and Mechanical Properties: Measured values obtained through standardized laboratory testing following ISO (International Organization for Standardization) standards (e.g., flexural strength, flexural modulus, water absorption, shear bond strength). These are objective measurements.
• Biocompatibility: Established by testing the material's composition (PEEK-OPTIMA™) against ISO 10993 standards, which define biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's a manufactured material, and its properties are inherent to its composition and manufacturing process, not learned from data.

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

Not applicable, as there is no "training set" for this type of device.

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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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