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510(k) Data Aggregation

    K Number
    K040656
    Device Name
    MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2004-05-25

    (74 days)

    Product Code
    HWC,KTT
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K954712,K981529,K993289,K983942,K040212
    Predicate For
    K050226,K083648,K122170
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Smith & Nephew, Inc. Intramedullary Hip Screws are for single use only.

    Device Description

    Intramedullary Hip Screw

    AI/ML Overview

    The provided text does not describe a study to prove acceptance criteria for a device using an AI algorithm.

    Instead, it is a 510(k) premarket notification summary for a medical device called an "Intramedullary Hip Screw" manufactured by Smith & Nephew, Inc. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design features, indications for use, and material composition.

    Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the information is not present in the provided text.

    Here's a breakdown of what the document does provide:

    1. A table of acceptance criteria and the reported device performance

    The document states:

    • Acceptance Criteria (Implied): Mechanical test data showed the device is "capable of withstanding expected in vivo loading without failure."
    • Reported Device Performance: "A review of the mechanical test data indicated that the Intramedullary Hip Screw is equivalent to predicate devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
    Acceptance Criteria (Implied)Reported Device Performance
    Withstand expected in vivo loading without failure.Indicated as equivalent to predicate devices; capable of withstanding expected in vivo loading without failure based on mechanical test data review.
    Equivalent to predicate devices in mechanical performance.Stated to be equivalent to predicate devices currently used clinically based on mechanical test data.
    Similar in indications for use, design, principles, & materials.Substantial equivalence is based on similarities in indications for use, design features, operational principles, and material composition to listed predicate devices.

    Missing Information (as per your request, because it's an AI-related prompt and this document is not AI-related):

    1. Sample sizes used for the test set and data provenance.
    2. Number of experts used to establish ground truth and their qualifications.
    3. Adjudication method for the test set.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance.
    5. If a standalone (algorithm only) performance study was done.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    7. The sample size for the training set.
    8. How the ground truth for the training set was established.
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