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    K Number
    K123393
    Device Name
    HEALICOIL SUTURE ANCHOR WITH REGENESORB
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2013-04-11

    (160 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K113294,K101459,K032197,K070925,K042778
    Why did this record match?
    Device Name :

    HEALICOIL SUTURE ANCHOR WITH REGENESORB

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

    The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

    Shoulder:
    Bankart lesion repairs
    Slap lesion repairs
    Capsular shift or capsulolabral reconstructions
    Acromioclavicular separation repairs
    Deltoid repairs
    Rotator cuff tear repairs
    Biceps tenodesis

    Knee:
    Extra-capsular repairs:
    Medial collateral ligament
    Lateral collateral ligament
    Posterior oblique ligament
    Patellar realignment and tendon repairs:
    Vastus medialis obliquous advancement
    Iliotibial band tenodesis.

    Foot & Ankle:
    Hallux valgus repairs
    Medial or lateral instability repairs/reconstructions
    Achilles tendon repairs/reconstruction
    Midfoot reconstructions
    Metatarsal ligament/tendon repairs/reconstructions

    Elbow:
    Ulnar or radial collateral ligament reconstructions
    Lateral epicondylitis repair
    Biceps tendon reattachment

    Device Description

    The HEALICOIL Absorbable Suture Anchor is a bioabsorbable suture anchor provided with up to three strands of non-absorbable sutures, pre-loaded on an insertion device and is available in two sizes, 4.75mm and 5.5mm.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided text for the K123393 submission for the HEALICOIL Absorbable Suture Anchor does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it uses the concept of "substantial equivalence" to predicate devices.

    Acceptance Criteria (Stated as Substantial Equivalence Goal)Reported Device Performance
    Insertion Strength substantially equivalent to predicate devicesDemonstrated substantially equivalent to predicate devices
    Pull-out Strength substantially equivalent to predicate devicesDemonstrated substantially equivalent to predicate devices
    In vitro degradation substantially equivalent to predicate devicesDemonstrated substantially equivalent to predicate devices

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

    The document does not specify the sample size used for the test set in the performance studies. It mentions that "performance testing was conducted," but no details on the number of samples for insertion strength, pull-out strength, or in vitro degradation are provided.

    The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, given they are performance tests specifically conducted for this submission.

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

    This information is not applicable to the type of device and study described. This device is a physical medical implant, and its performance is evaluated through biomechanical testing (insertion strength, pull-out strength, degradation), not through subjective interpretation by human experts to establish ground truth.

    4. Adjudication Method for the Test Set

    This is not applicable as the studies described are biomechanical performance tests, not studies requiring expert adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret data, often with and without AI assistance, to assess the AI's impact on human performance. This submission is for a physical orthopedic implant.

    6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

    No, a standalone algorithm-only study was not done because this device is a physical orthopedic implant, not an algorithm or AI system.

    7. Type of Ground Truth Used

    The "ground truth" for the performance studies would be the objective measurements obtained from the biomechanical tests themselves. For example:

    • Insertion Strength: The force required to insert the anchor, measured by a load cell.
    • Pull-out Strength: The force required to pull the anchor out, measured by a load cell.
    • In vitro Degradation: Measurements of material properties or mass loss over time in a controlled environment.

    This is objective, quantifiable data from physical experiments, not expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device ground truth.

    8. Sample Size for the Training Set

    This information is not applicable. This device is a physical medical implant, not an AI/machine learning model that requires a training set of data.

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

    This information is not applicable, as there is no training set for this device.

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