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510(k) Data Aggregation

    K Number
    K974703
    Device Name
    CARBON FIBER BREAST BOARD
    Manufacturer
    MEDTEC, INC.
    Date Cleared
    1998-03-10

    (84 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARBON FIBER BREAST BOARD

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

    The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.

    Device Description

    Carbon Fiber Breast Board

    AI/ML Overview

    I am sorry, but based on the provided documents, I cannot extract the information required to describe the acceptance criteria and the study proving the device meets them. The documents are a 510(k) clearance letter and an Indications for Use statement for a "Carbon Fiber Breast Board." These documents confirm the regulatory clearance of the device but do not contain detailed study information such as:

    • Acceptance criteria: There's no mention of specific performance metrics or thresholds the device needed to meet.
    • Reported device performance: No data on the device's performance is provided.
    • Study details: Information regarding sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth establishment, or training set sizes is absent.

    The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria for a novel device.

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