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510(k) Data Aggregation

    K Number
    K011955
    Device Name
    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
    Manufacturer
    METRON MEDICAL AUSTRALIA PTY LTD
    Date Cleared
    2001-07-16

    (24 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Type
    Special
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100

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

    The indications for use are:

    • Relief or reduction of pain; 1.
    • Reduction of muscle spasm; 2.
    • Joint contracture; and 3.
      1. Local increase in circulation.
    Device Description

    Modification to: Accusonic Plus, Model AP-100

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Accusonic Plus, Model AP-100." This letter indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use (relief or reduction of pain, reduction of muscle spasm, joint contracture, and local increase in circulation).

    However, the letter does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications. These types of details would typically be found in the 510(k) summary or the full submission, which are not provided here.

    Therefore, I cannot fulfill your request with the given input. The information you are asking for is not present in this regulatory clearance letter.

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