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    K Number
    K062960
    Device Name
    CONSERVE FEMORAL RESURFACING COMPONENT
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2006-12-01

    (63 days)

    Product Code
    KXA
    Regulation Number
    888.3400
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONSERVE FEMORAL RESURFACING COMPONENT

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

    The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

    The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.

    Device Description

    The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:

    • Manufactured from Cobalt Chrome Alloy .
    • 11 Sizes in 2mm increments .
    AI/ML Overview

    The provided text describes a 510(k) summary for the CONSERVE® Femoral Resurfacing Component but does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

    The document is for a medical device (a prosthetic hip component) and uses "substantial equivalence" to a predicate device as its basis for clearance, not performance metrics from a study against predefined acceptance criteria for an AI/ML algorithm.

    Therefore, most of the requested information cannot be extracted from this document, as it outlines a different type of regulatory submission.

    Here's what can be stated based on the provided text:

    Acceptance Criteria and Device Performance for the CONSERVE® Femoral Resurfacing Component:

    This document is a 510(k) summary for a physical medical device (CONSERVE® Femoral Resurfacing Component), not an AI/ML-driven device. As such, it does not detail specific quantitative acceptance criteria or a study proving the device meets these criteria in the manner typically described for AI/ML performance. Instead, its acceptance is based on substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence to Predicate Device: Indications for use, design, and materials are substantially equivalent to the Orthomet Resurfacing Femoral Component. The fundamental scientific technology has not changed.The CONSERVE® Femoral Resurfacing Component's indications for use and design are identical to the Orthomet Resurfacing Femoral Component. The materials are substantially equivalent. This supports the safety and effectiveness of the component.
    Intended Use: For hemi resurfacing to reduce or relieve pain and/or improve hip function in skeletally mature patients with non-inflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, painful hip dysplasia). For cemented use only.The device's stated indications for use match the criteria for intended use, and are identical to the predicate device.

    Regarding the specific points for an AI/ML study, the information is not present in the provided text:

    • 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/ML algorithm evaluated on data sets.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical hip implant is not established in this manner.
    • 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
    • 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
    • 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML ground truth. The "truth" for this device relates to its material properties, design specifications, and clinical performance (which is inferred from historical data of the predicate device).
    • 8. The sample size for the training set: Not applicable.
    • 9. How the ground truth for the training set was established: Not applicable.
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