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510(k) Data Aggregation

    K Number
    K960222
    Date Cleared
    1996-03-08

    (52 days)

    Product Code
    Regulation Number
    888.1100
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PERCUTANEOUS ENDOSCOPIC DISCECTOMY

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

    The instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hemias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons.

    The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).

    Device Description

    Discectorny Instruments are made of medical grade stainless steel. They are used for partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes. Percutaneous access is achieved by small incisions and introduction of sleeves.

    AI/ML Overview

    The provided text describes surgical instruments and does not contain information about an AI/ML device or its performance characteristics. Therefore, I cannot generate the requested table and study information.

    The document discusses:

    • Device Name: Orthopedic Manual Surgical Instruments, Percutaneous Discectorny System (Trade Name: Forceps, dilator, working sleeves, cannulas, trephines, deflectors)
    • Intended Use: Partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes (Percutaneous Lumbar Disc Decompression).
    • Technological Characteristics: Basic arthroscopic instruments with longer shafts, integrated in tubular sheaths, providing punching, grasping, cutting, suction/irrigation functions.
    • Performance Data: Instruments were tested to assure no breakage of the jaw or other parts.
    • Clinical Tests: "No Clinical tests were performed."

    Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, and this document pertains to manual surgical instruments with no mention of AI/ML, I cannot fulfill the request as specified.

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