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510(k) Data Aggregation

    K Number
    K971018
    Device Name
    SMC ACETABULAR COMPONENT
    Manufacturer
    SIGNAL MEDICAL CORP.
    Date Cleared
    1997-10-24

    (218 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K950827
    Why did this record match?
    Reference Devices :

    K950827

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

    Osteoarthritis
    Rheumatoid Arthritis
    Traumatic Arthritis
    Where the use of a more conservative procedure has failed or is unacceptable

    Device Description

    The Signal Medical Corporation Acetabular Component is manufactured of forged titanium, 6 aluminum, 4 vanadium, ELI metal (ASTM F-136, F620). The design is made available in thirteen (13) sizes ranging from 48mm to 72mm. The outside diameter of the cup is coated with a commercially pure titanium sintered beaded surface to enhance either bone ingrowth or cement adherence depending on the choice of the surgeon. Also three circumferentially spaced pins or spikes at 120 degree intervals provide for a primary skeletal fixation and reduce the chance of rotation. The inside assembly of the device and the polyethylene insert are identical to the StelKast Corporation Proform Porous Acetabular Assembly (K950827). The inside diameter system provides a locking ring and three pegs that secure the ultra high molecular weight polyethylene articular surface in place. The acetabular inserts are identical to the StelKast Corporation (K950827) inserts. The ultra high molecular weight polyethylene inserts are secured to the acetabular shell as described above and are designed to accept 28mm femoral heads on their inside diameter.

    AI/ML Overview

    Unfortunately, the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Signal Medical Corporation Acetabular Component. The documents primarily focus on the 510(k) submission and FDA clearance process, detailing the device description, indications for use, and a letter confirming substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case study results.

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