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510(k) Data Aggregation

    K Number
    K130385
    Device Name
    COMPRESSIBLE LIMB SLEEVE SYSTEM
    Manufacturer
    MAXSTAR INDUSTRIAL CO. LTD.
    Date Cleared
    2014-02-18

    (368 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K173158
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UAM-8100 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

    Device Description

    Compressible Limb Therapy System UAM-8100

    AI/ML Overview

    This document, a 510(k) clearance letter for the Compressible Limb Therapy System UAM-8100, does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

    The letter primarily:

    • Confirms that the FDA has reviewed the 510(k) premarket notification.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines post-market regulatory requirements (e.g., registration, labeling, adverse event reporting).
    • Provides the "Indications for Use" for the device.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance: This information is not present. The letter is a clearance for marketing, not a detailed technical report of performance.
    2. Sample size used for the test set and the data provenance: Not mentioned.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
    4. Adjudication method for the test set: Not mentioned.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
    6. If a standalone study was done: Not mentioned.
    7. The type of ground truth used: Not mentioned.
    8. The sample size for the training set: Not mentioned.
    9. How the ground truth for the training set was established: Not mentioned.

    To obtain this type of information, one would typically need to review the actual 510(k) submission document itself, which contains the detailed technical and clinical study data submitted to the FDA for review. The letter provided is the FDA's decision based on that submission.

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