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510(k) Data Aggregation

    K Number
    K052763
    Manufacturer
    Date Cleared
    2005-11-10

    (41 days)

    Product Code
    Regulation Number
    888.3060
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STELLA CERVICAL PLATE

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Stella Cervical Plate." This type of document does not contain any information about acceptance criteria or a study proving device performance against such criteria.

    The purpose of a 510(k) clearance is to establish that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics. This process typically relies on demonstrating equivalence in design, materials, and sometimes testing that compares the new device to the predicate device, but it does not involve clinical effectiveness studies or the establishment of specific acceptance criteria for a device's performance in the way implied by your request.

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

    1. A table of acceptance criteria and reported device performance: This is not present.
    2. Sample size used for the test set and data provenance: No such test set is described.
    3. Number of experts used to establish ground truth and qualifications: Not applicable, as no ground truth is established in this context.
    4. Adjudication method: Not applicable.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or mentioned.
    6. Standalone (algorithm only) performance study: Not applicable, as this is a physical medical device, not an AI algorithm.
    7. Type of ground truth used: Not applicable.
    8. Sample size for the training set: Not applicable (no AI training set).
    9. How ground truth for the training set was established: Not applicable.

    The letter simply states that the FDA reviewed the premarket notification and found the device substantially equivalent to a predicate device, thereby allowing it to be marketed.

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