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510(k) Data Aggregation

    K Number
    K172165
    Device Name
    Q-Fix Suture Anchor
    Manufacturer
    ArthroCare Corporation
    Date Cleared
    2017-08-17

    (30 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K133727
    Why did this record match?
    Reference Devices :

    K133727

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

    The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

    Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis

    Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair

    Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment

    Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure

    Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction

    Hip: Acetabular labral repair

    Device Description

    The Q-Fix Suture Anchor (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. This family of suture anchors previously was available in two sizes, 1.8mm and 2.8mm. This submission proposes an additional size of Q-Fix Suture Anchor, the 1.8mm Q-Fix MINI Suture Anchor.

    The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

    The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

    The Q-Fix Suture Anchor consists of the bone anchor and associated instruments for implanting the bone anchor.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device (Q-Fix Suture Anchor) and does not contain information related to software or AI device performance studies. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical bench testing.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets those criteria, as there is no mention of a software or AI-driven device, nor are there any clinical studies involving human readers or ground truth establishment in the context of AI performance.

    The document states:

    • "No clinical or animal data are included in this submission." (Page 4, under "Clinical Data")
    • "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing." (Page 4, under "Non-Clinical Data")

    This submission is for a physical medical device (a suture anchor), and the testing described is mechanical, not related to diagnostic accuracy or AI performance.

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