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510(k) Data Aggregation

    K Number
    K110399
    Device Name
    GLADIATOR PLASMA CLASSIC HIP STEM
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2011-05-10

    (88 days)

    Product Code
    KWA,JDL,LZO
    Regulation Number
    888.3330
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K021346,K012091,K004043,K060358
    Why did this record match?
    Device Name :

    GLADIATOR PLASMA CLASSIC HIP STEM

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

    The GLADIATOR® Plasma Classic Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

    Indications for Use:

    1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
    2. inflammatory degenerative joint disease such as rheumatoid arthritis;
    3. correction of functional deformity; and,
    4. revision procedures where other treatments or devices have failed

    GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

    Device Description

    The GLADIATOR® Plasma Classic Hip Stem is a straight uncemented stem, and features a rectangular cross-section, proximally a trapezoidal section manufactured from base material of Titanium alloy (Ti6Al4V - ASTM F620, equivalent to ISO 5832-3). The profile tapers vertically both in frontal and lateral view, to achieve fixation stability in three planes. The stem possesses a 0.5mm thick titanium plasma spray coating on the proximal third of the stem surface, conforming to ASTM F1580. The stem length ranges from 125 mm in length, is available in 10 sizes (1-10), and features 0.5mm thick titanium plasma spray on the proximal third of the stem surface. The stem is available in standard and extended neck offsets.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the GLADIATOR® Plasma Classic Hip Stem. This submission aims to demonstrate substantial equivalence to existing predicate devices, not to prove the device meets specific acceptance criteria through a clinical study in the way a new drug or high-risk medical device might.

    Here's an analysis based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Nonclinical Testing:
    Distal and Proximal Fatigue Evaluation (per ISO 7206-4, -6 and -8)The GLADIATOR® Plasma Classic Hip Stem "has been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8." (Implies successful completion of these tests to demonstrate mechanical durability and safety comparable to predicate devices).
    Range of Motion Evaluation (per ISO 21535)The range of motion "was evaluated for GLADIATOR® Plasma Classic Hip Stem according to ISO 21535 (2007)." (Implies the range of motion is within acceptable limits, comparable to predicate devices and suitable for intended use).
    Substantial Equivalence (General Criteria for 510(k) pathway):
    Identical Indications for Use to Predicate Devices"The indications for use of the GLADIATOR® Plasma Classic Hip Stem are identical to the previously cleared predicate devices." (This is a statement of claim, not a performance metric per se, but a key acceptance criterion for 510(k)).
    Substantially Equivalent Design Features to Predicate Devices"The design features of the subject device are substantially equivalent to the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices." (Again, a statement of claim for 510(k); the nonclinical tests would support this claim regarding performance).
    Identical Materials to Predicate Devices"The materials used for the GLADIATOR® Plasma Classic Hip Stem are identical to the materials used for the predicate devices." (A direct statement comparing materials for substantial equivalence).
    Safety and Effectiveness Adequately Supported by Substantial Equivalence Information, Materials Information, and Analysis Data"The safety and effectiveness of the GLADIATOR® Plasma Classic Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." (This is the ultimate conclusion, asserting that the provided nonclinical data and comparison to predicates are sufficient for regulatory approval via 510(k)). This is an overall acceptance criterion for the submission itself.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: The document does not specify a "test set" in the context of clinical data for the new device. The testing mentioned in the nonclinical section (fatigue and range of motion) would typically involve a small number of physical samples of the device components, rather than patient data. The document does not provide the number of samples used for these nonclinical tests.
    • Data Provenance: The data provided is purely nonclinical (mechanical testing). Therefore, there is no country of origin for patient data and it is not retrospective or prospective clinical data.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    • Not applicable. This is not a clinical study involving diagnosis or outcome assessment where expert consensus on "ground truth" would be established. The "ground truth" for the nonclinical tests would be the predetermined international standards (ISO 7206, ISO 21535) and the results of the physical tests against these standards.

    4. Adjudication Method for the Test Set:

    • Not applicable. There is no "test set" in the clinical sense requiring an adjudication method. The nonclinical tests follow established international standards.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

    • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not provided for the class III hip stem." This indicates that no human factors or reader performance studies were conducted.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

    • Not applicable. This device is a physical hip stem, not an algorithm or AI product.

    7. The Type of Ground Truth Used:

    • For the nonclinical tests, the "ground truth" is the compliance with established international standards (ISO 7206 series for fatigue and ISO 21535 for range of motion). These standards define acceptable performance parameters for hip joint prostheses.

    8. The Sample Size for the Training Set:

    • Not applicable. There is no training set in the context of a machine learning model or clinical trial for this device. The "training" for this type of device involves engineering design, material selection, and manufacturing processes guided by established engineering principles and prior knowledge from predicate devices.

    9. How the Ground Truth for the Training Set Was Established:

    • Not applicable. As there's no training set for a data-driven model, there's no ground truth to establish for it. The underlying "ground truth" for the device's design and manufacturing is the body of medical engineering knowledge, regulatory requirements, and the successful performance history of its predicate devices.
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