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Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.

Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Vericore® Gradient Temporary Disc (K152443)
Predicate Device (Primary for performance): Copra-Temp discs manufactured by White Peaks Dental Systems (K131664)

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance data primarily in comparison to a predicate device, and against ISO standards. The acceptance criteria are implicitly derived from the ISO standard requirements.

Summary of Device Performance against Acceptance Criteria:

• Flexural Strength: The device's reported flexural strength (82 MPa) meets the minimum requirement of 50 MPa per ISO 10477.
• Chemical Solubility & Water Sorption: The document states that "all tests passed the requirements" for these two characteristics according to ISO 10477. The specific numerical acceptance criteria from the ISO standard are not explicitly listed, but the reported values (-0.2 µg/mm³ for solubility and 22 µg/mm³ for water sorption) are provided in comparison to the predicate. The statement "all tests passed the requirements" implies these values were within acceptable limits.
• Biocompatibility: The device demonstrated no irritation effects on test subjects for the oral mucosa, indicating it met the biocompatibility requirements related to its specific shading ingredients.

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

• Sample Size for Test Set: Not specified in the provided document. The tests conducted (Flexural Strength, Water Sorption, Chemical Solubility, Biocompatibility focusing on irritation effects) would have involved specific numbers of samples, but these are not detailed.
• Data Provenance: Not specified in terms of country of origin or retrospective/prospective nature. The testing was conducted by Whip Mix Corporation ("Whip Mix performed biocompatibility test...") for the specific shading ingredients, or referenced predicate data based on similar testing ("same tests as performed on the predicate K131664" and "White Peaks performed biocompatibility tests").

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

• This information is not applicable to this type of device and study. The testing described (mechanical properties and biocompatibility) relies on objective measurement and laboratory analysis, not expert consensus or interpretation of subjective data like images. There is no "ground truth" established by experts in the context of diagnostic accuracy for this device.

4. Adjudication Method for the Test Set

• This information is not applicable as there is no "adjudication" in the context of mechanical properties or biocompatibility testing for this device. The results are based on objective measurements against defined standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting cases (e.g., radiology AI). The Vericore® Gradient Temporary Disc is a dental material, not a diagnostic imaging device.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For Flexural Strength, Chemical Solubility, and Water Sorption: The "ground truth" (or reference standard) is established by physical measurements according to the protocols defined in ISO 10477.
• For Biocompatibility: The "ground truth" is established by biological response assessments (e.g., observing for irritation effects) conducted according to relevant parts of the ISO 10993 series (specifically mentioned: ISO:10993-3, ISO:10993-5, and ISO:10993-10 for the predicate, and performed for oral mucosa irritation for the new device).

8. The Sample Size for the Training Set

• This concept is not applicable. This device is a physical dental material, not a machine learning model that requires a "training set."

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

• This concept is not applicable as there is no training set for this type of device.

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