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510(k) Data Aggregation

    K Number
    K031804

    Validate with FDA (Live)

    Device Name
    COMPRESS DISTAL FEMORAL REPLACEMENT
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2003-12-18

    (190 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K945028,K972401
    Predicate For
    K011996,K041352,K043547
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.

    The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.

    Device Description

    The ComPreSs™ Distal Femoral Replacement is a metallic femoral segmental fixation stem intended to replace the distal part of the femur in cases of severe bone loss. The design of the ComPreSs™ stem allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.

    AI/ML Overview

    The provided documentation describes the ComPreSs™ Distal Femoral Replacement, a medical device. Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Mechanical Strength/Safety: Device addresses all failure mechanisms.Non-Clinical Testing: "Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study."
    Stress Shielding: Device produces less stress shielding than standard cemented implants.Non-Clinical Testing: "Results of mechanical testing showed that the ComPreSs™ Distal Femoral Replacement produces less stress shielding than a standard cemented implant."
    Clinical Equivalence: Clinically substantially equivalent to similar knee prostheses for similar indications.Clinical Results: "The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent to similar knee prostheses implanted for similar indications."
    Substantial Equivalence: Based on mechanical testing and clinical data, the device is substantially equivalent to the predicate device.Summary: "Based on the results of mechanical testing and clinical data, the ComPreSs™ Distal Femoral Replacement is substantially equivalent to the predicate device."

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

    The document states, "Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study." and then refers to "The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent..."

    • Sample Size for Clinical Study (Test Set): The specific sample size for the clinical study is not provided in the given text.
    • Data Provenance: The country of origin of the data is not specified. The text only mentions "clinical results." It is likely prospective, as it refers to a "clinical study" being initiated after mechanical testing.

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

    This information is not provided in the document. The text only mentions "clinical results" and "clinical data" without detailing how ground truth was established by experts.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    There is no mention of an MRMC comparative effectiveness study or any effect size of human readers improving with or without AI assistance. The device in question is a physical medical implant, not an AI-assisted diagnostic tool.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

    This question is not applicable as the device is a physical implant and not an algorithm.

    7. The Type of Ground Truth Used

    The type of ground truth used for the "clinical results" is not explicitly stated. Given it's a femoral replacement, the ground truth would likely be based on patient outcomes (e.g., pain reduction, range of motion, implant stability, absence of complications) as observed in the clinical study, compared to the outcomes of the predicate device. However, this is inferred, not explicitly stated.

    8. The Sample Size for the Training Set

    This information is not provided. The text refers to "clinical results" but does not distinguish between a training set and a test set for this device type. Given it's a medical implant, training sets in the context of biological data or machine learning are not typically relevant here; the "training" would be more akin to in-vitro or in-vivo testing to optimize the design, which isn't detailed with sample sizes in this summary.

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

    This information is not provided and is largely not applicable in the conventional sense for a physical medical implant. The design and testing would involve engineering principles and mechanical testing to establish performance parameters, rather than "ground truth" derived from patient data for a training set in the way one would for an algorithm.

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