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White Peaks Copra Temp is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

White Peaks Copra Temp is a device made from high quality 100% PMMA (polymethylmethacrylate) and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed using CAD technology and uses scans or models for the basis of the restoration to be milled. Copra Temp Blanks are available in a variety of thicknesses for different milling systems and are also available in a variety of Vita shades.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Copra Temp device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices (Zeno PMMA Disc and BRIGHTGLASS Discs) through material properties and intended use. The key performance metric highlighted is flexural strength.

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

The document does not specify a separate "test set" in the context of a clinical performance study. The data presented for flexural strength is from pre-clinical testing.

• Sample Size: Not explicitly stated for flexural strength testing, but it would have been part of the pre-clinical testing mentioned.
• Data Provenance: The testing was "pre-clinical," implying laboratory or bench testing rather than human subject data. The country of origin for the data is implicitly Germany, where White Peaks Dental Systems GmbH & Co. KG is located. The data is retrospective in that it's reported from completed tests.

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

This information is not applicable as the submission describes pre-clinical material testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" for flexural strength would be the measured value according to established ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a material (temporary crown and bridge resin), not an imaging or diagnostic device that typically involves human readers interpreting results.

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 software.

7. The Type of Ground Truth Used

The ground truth used for the reported performance (flexural strength) was objective measurement according to recognized international standards. The document states:

• "Pre-clinical testing was performed to determine the physical properties of Copra Temp and for Biocompatibility and the tests passed per the requirements of ISO:10477, ISO:10993-1, ISO: 10993-3, ISO: 10993-5 and ISO:10993-10."
  • ISO 10477: Dental polymer-based crown and veneering materials (likely where flexural strength methods are derived).
  • The other ISO standards relate to biocompatibility, not direct performance comparison for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device or software. The device itself is a material for fabrication.

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

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

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CopranColor is intended to be used as the coloring agent for the shading of white zirconia ceramic materials that are intended to be used by professional dental technicians to fabricate all-ceramic dental restorations for the sole use of particular patients.

CopranColor is a device that may be used as an accessory to zirkonium dioxide dental restaurations such as Copran ZR /Origin YZ. Together with the zirconium dioxide blanks the CopranColor can be used by professional dental technicians for fabrication of all.ceramic restorations.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the CopranColor device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a Class II medical device (dental porcelain powder). For such devices, acceptance criteria are typically related to material properties, biocompatibility, and functional equivalence to a predicate device, rather than diagnostic accuracy metrics common for AI/ML devices.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "Bench testing was performed to ensure that the CopranColor met its specifications" and "Biocompatibility testing was performed." However, no numbers regarding the quantity of samples (e.g., number of colored zirconia blanks, number of biocompatibility test samples) are provided.
• Data Provenance: Not explicitly stated. It's safe to assume the testing was conducted internally by White Peaks Dental Systems GmbH & Co. KG or by a contracted lab, likely in Germany given the company's address. The document does not specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This device is a coloring agent for dental materials, not a diagnostic AI/ML device requiring expert ground truth for interpretation. Therefore, this information is not applicable and not provided in the document.

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

• Not applicable as this is a material science device, not an AI/ML diagnostic interpretation system.

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. This is not an AI/ML device that assists human readers.

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

• Not applicable. This device is not an algorithm.

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

• For the material and biocompatibility testing, the "ground truth" would be established through pre-defined material specifications and standards (e.g., ISO standards for dental materials) and validated biocompatibility testing protocols. This is intrinsic to material science and regulatory compliance for such devices, rather than a "ground truth" derived from expert consensus or pathology data as seen in diagnostic tools.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The development of the coloring agent would involve chemical formulation and iterative testing, but not in the sense of an "AI training set."

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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Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for:

• Crown frameworks in the anterior and posterior areas
• Bridge frameworks in the anterior and posterior areas
• Primary conical crowns and telescopic crowns
• Cantilevered bridges with a max. of one pontic having a premolar width
• Inlays, Onlays, Veneers

Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. The devices are sold in different shapes, figures and dimensions to match the specification of the different CAD/CAM milling machines used to generate the final restaurations. This may be shapes like disks, cubes, bars and cylinders.

The provided text is related to a 510(k) premarket notification for a dental device (Copran Zr/Origin YZ Zirconia blanks) and does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is primarily a summary of the 510(k) submission, including device information, indications for use, and an FDA letter confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Information about experts used to establish ground truth.
4. Adjudication methods.
5. Details on an MRMC comparative effectiveness study or effect sizes.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document focuses on the regulatory submission process and the determination of substantial equivalence, not the detailed technical performance or validation studies that would contain the requested information.

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