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510(k) Data Aggregation

    K Number
    DEN200035
    Device Name
    BEAR (Bridge-Enhanced ACL Repair) Implant
    Manufacturer
    Miach Orthopaedics, Inc.
    Date Cleared
    2020-12-16

    (195 days)

    Product Code
    QNI
    Regulation Number
    888.3044
    Type
    Direct
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BEAR® (Bridge Enhanced ACL Repair) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.

    Device Description

    The BEAR® Implant (22 mm in diameter and 45mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the torn ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.

    AI/ML Overview

    The provided text describes the clinical study (BEAR II) conducted to support the safety and effectiveness of the BEAR® (Bridge-Enhanced ACL Repair) Implant. It is important to note that this document is a regulatory submission for a medical device and not a study validating an AI-powered diagnostic device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., ground truth establishment for training, expert consensus for test sets, MRMC studies, standalone algorithm performance) are not applicable to this submission.

    However, I can extract and present the acceptance criteria and the study results relevant to the BEAR® Implant's clinical performance, as described in the provided text.

    Acceptance Criteria and Reported Device Performance for BEAR® Implant

    The acceptance criteria for the BEAR® Implant are primarily demonstrated through non-inferiority testing against a control (ACLR – ACL Reconstruction with autograft) for primary effectiveness endpoints and superiority/non-inferiority for secondary effectiveness endpoints. Safety parameters are also assessed for comparable rates between the BEAR group and the control group.

    1. Table of Acceptance Criteria and Reported Device Performance

    The core of the clinical acceptance is based on the primary effectiveness endpoints of the BEAR II study: IKDC Subjective Score and Instrumented AP Knee Laxity.

    Acceptance Criteria (Endpoint)Null Hypothesis (for non-inferiority)Reported Device Performance (Mean ± SD)p-valueMeets Criteria?
    Primary Effectiveness Endpoints (24 Months Post-Surgery)
    IKDC Patient Reported ScoreTrue difference in means (BEAR - Control) ≤ -11.5 (clinically significant difference)BEAR: 88.6 ± 13.4Control: 84.6 ± 13.3
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