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510(k) Data Aggregation

    K Number
    K123680
    Device Name
    COPRANCOLOR
    Manufacturer
    WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
    Date Cleared
    2013-02-21

    (83 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COPRANCOLOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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.

    Acceptance Criteria (Inferred from documentation)Reported Device Performance
    Material Specifications: Ensuring CopranColor meets unspecified internal specifications related to its use as a coloring agent for zirconia dental restorations."All tests were verified to meet acceptance criteria." (Specific details of these criteria or test results are not provided).
    Biocompatibility: Confirmation that the materials used in CopranColor are safe for use in dental restorations."Biocompatibility testing was performed to verify the equivalent safety of the materials that are used." The document also states, "The materials used in the new devices are all biocompatible as the predicate device."
    No Negative Effect on Physical Material Properties: The coloring liquid should not adversely affect the physical properties of the zirconia blanks it colors."The colouring liquid has no negative effect to the physical material properties." (No specific test results quantifying this are provided, but this is explicitly stated).
    Substantial Equivalence: Demonstrated equivalence to predicate device (ZENOTEC Zr / ZENOSTAR Color Zr) in terms of intended use, operating principles, technology, and manufacturing process.The document concludes that "CopranColor in combination with the zirkonia blanks has the same technological characteristics as the predicate device ZENOTEC Zr / ZENOSTAR Color Zr" and "we conclude the device is substantially equivalent to the predicate device."

    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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