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510(k) Data Aggregation

    K Number
    K013513
    Device Name
    DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
    Manufacturer
    PAIN CONCEPTS, INC.
    Date Cleared
    2002-01-17

    (87 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAIN CONCEPTS, INC.

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

    The Pain Concepts' Dekompressor™ Percutaneous Lumbar Discectomy Probe is intended for use for the aspiration of disc material during percutaneous lumbar discectomies.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Dekompressor™ Percutaneous Lumbar Discectomy Probe." It indicates that the device has been found substantially equivalent to a predicate device already on the market.

    However, this document does not contain any information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set information for an AI/algorithm.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is purely about regulatory clearance, not about a detailed performance study of an AI-powered device.

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