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510(k) Data Aggregation

    K Number
    K012061
    Date Cleared
    2001-07-19

    (17 days)

    Product Code
    Regulation Number
    890.5100
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUPERIOR BATH, MODEL 6300

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

    The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

    Device Description

    Superior Bath Model 6300

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the "Superior Bath Model 6300" does not contain any information regarding:

    • Acceptance criteria for performance.
    • Results of a study to prove the device meets acceptance criteria.
    • Details about sample sizes (training or test sets).
    • Data provenance.
    • Number or qualifications of experts.
    • Ground truth establishment or type.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance studies.

    The document is a standard FDA clearance letter confirming that the device, a bath for patients, is substantially equivalent to a legally marketed predicate device. It defines the "indications for use" as "The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only."

    Therefore, I cannot fulfill your request for the tables and study details based on the information provided in the input.

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