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510(k) Data Aggregation

    K Number
    K182919
    Device Name
    SI-Restore® Sacroiliac Joint Fixation System
    Manufacturer
    Biofusion Medical
    Date Cleared
    2019-01-25

    (98 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K112028
    Predicate For
    K200868
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

    Device Description

    The SI-Restore® Sacroiliac Joint Fixation System consists of a cannulated titanium (Ti 6AI4V ELI, per ATSM F136) screw with a titanium (Ti 6AI4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The Implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation for and placement of the implant.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for the Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System. This document describes a medical device (a bone fixation system), not a software or AI/ML-based device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.

    The document discusses the following types of performance data for this physical medical device:

    • Static Axial Pull-out and Static Torque to Failure testing (per ASTM F543-13)
    • Static Three-Point Bending and Dynamic Three-Point Bending (per ASTM F1264-14)

    These tests confirmed that the device performed as intended and supported the claim of substantial equivalence to a legally marketed predicate device (SI-LOK™ Sacroiliac Joint Fixation System, K112028).

    Since the request specifically asks about acceptance criteria and studies for an AI/ML device, and this document pertains to a physical orthopedic implant, I can only state that the requested information is not present in the provided text because the device in question is not an AI/ML product.

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