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510(k) Data Aggregation

    K Number
    K133213
    Device Name
    STARCERAM
    Manufacturer
    H.C. STARCK CERAMICS GMBH
    Date Cleared
    2013-12-05

    (48 days)

    Product Code
    EIH,ELL
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K081263,K112710
    Why did this record match?
    Reference Devices :

    K081263, K112710

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

    Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.

    Device Description

    Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a dental blank device, StarCeram®, and primarily addresses substantial equivalence to predicate devices, not performance criteria in the context of an AI/ML medical device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

    Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present:

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

    Acceptance CriteriaReported Device Performance
    No specific performance acceptance criteria for the device's output (e.g., diagnostic accuracy, sensitivity, specificity) are mentioned in this document. The submission focuses on substantial equivalence to existing predicate devices.Biocompatibility and cytotoxicity testing showed that all versions of the product comply with ISO 10993-1, demonstrating the material's safety for use in the human body.
    For the previously cleared StarCeram® Z-Med and Z-Al-Med HD (K081263), the only change to the cleared products is the additional indication for use related to all-ceramic restoration. All other aspects, including physical properties, remain unchanged.(No specific performance data is provided for this added indication, relying on substantial equivalence to the original clearance.)
    For StarCeram® Z-Al-Med-HD Colour, StarCeram® Z-Al-Med HD Translucent, and StarCeram® Z-Med TransColour, the primary difference from the predicate is the exact combination of qualities of zirconium dioxide used. All other physical properties are identical to the StarCeram® products cleared in K081263.(No specific performance data is provided for these material variations, relying on biocompatibility and substantial equivalence.)

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

    This information is not applicable as the submission does not describe a clinical study measuring device performance in the context of diagnostic accuracy or similar metrics. The "Performance Data" section explicitly states, "No performance data was required or provided." The evaluation focused on biocompatibility and substantial equivalence.

    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 information is not applicable. No test set or ground truth in the context of a diagnostic or therapeutic AI/ML device is mentioned. The assessment revolved around material properties and comparison to predicate devices.

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

    This information is not applicable.

    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

    This information is not applicable. The device is a dental blank, not an AI/ML diagnostic or assistive tool for human readers.

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

    This information is not applicable.

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

    This information is not applicable. The "ground truth" in this context would be the successful demonstration of biocompatibility per ISO standards and the physical properties aligning with predicate devices, rather than a clinical ground truth for a diagnostic task.

    8. The sample size for the training set

    This information is not applicable. No AI/ML model training is described.

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

    This information is not applicable.

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