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510(k) Data Aggregation

    K Number
    K181746
    Device Name
    MICRORAPTOR Knotless Suture Anchor
    Manufacturer
    Smith and Nephew, Inc.
    Date Cleared
    2018-09-28

    (88 days)

    Product Code
    MAI,MBI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K180361,K071586
    Why did this record match?
    Device Name :

    MICRORAPTOR Knotless Suture Anchor

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

    The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications:

    Hip
    • Acetabular labrum repair/reconstruction

    Shoulder

    • Capsular stabilization
    • Bankart repair
    • Anterior shoulder instability
    • SLAP lesion repairs
    • Capsular shift or capsulolabral reconstructions
    • Biceps tenodesis
    • · Rotator cuff tear repairs
    Device Description

    The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. This device is provided sterile, for single use only.

    AI/ML Overview

    The provided text is a 510(k) Summary for the MICRORAPTOR Knotless Suture Anchor, a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical or AI-based study.

    Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    The "Summary Performance Data" section mentions that the device met "performance specifications for insertion strength and pullout strength" and "met performance specifications for cyclic loading based on the predicate." However, it does not explicitly state what those specifications (acceptance criteria) were or provide numeric results of the testing. It implies that these were mechanical engineering tests, not studies involving human readers or AI.

    This document is for a physical medical device (suture anchor), not software or an AI device. The questions in the prompt are more relevant to AI/software device submissions, particularly those involving image analysis or diagnostic support.

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