LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984458
    Device Name
    DEPUY ACE SPIDER PLATE
    Manufacturer
    DEPUY ACE MEDICAL CO.
    Date Cleared
    1998-12-31

    (16 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K965028
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • · Fixation of Metaphyseal Fractures of the Distal Tibia
    • · Proximal Metaphyseal Tibial Fractures
    • · Calcaneus Body Fractures
    • · Proximal Humeral Head/Shaft Fractures
    • · Distal Femur Fracture -- Comminuted Shaft Fractures
    Device Description

    The DePuy ACE Spider Plate is a low profile, "one-hole plate" design with a family of diameters to account for various fracture locations and spiked projections to engage the metaphyseal bone in any anatomic region. Five different overall diameters (three small, two large) have been designed to provide adequate clinical flexibility. The top profile has an overall diameter with a central hole for screw fixation; two of the washers have an offset screw hole with an additional k-wire hole. There are eight radiused cutouts producing eight arms that are designed to engage the metaphyseal bone.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device called the "DePuy ACE Spider Plate." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a study with acceptance criteria.

    Therefore, the input does not contain information about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for a test set or data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method for a test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth used (expert consensus, pathology, outcomes data).
    8. Sample size for a training set.
    9. How ground truth for the training set was established.

    The document focuses on establishing substantial equivalence to a predicate device (Acumed Suture Washer) based on similar design and function, rather than presenting a performance study against predefined acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1