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510(k) Data Aggregation

    K Number
    K250498
    Device Name
    BPS Wrist Fracture System
    Manufacturer
    OrthoNovis, Inc.
    Date Cleared
    2025-03-17

    (25 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K242343,K191641
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BPS Wrist Fracture System is indicated for the fixation of simple and complex intra-articular and extra-articular fractures, and for osteotomies of the distal radius in adults. The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.

    Device Description

    The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius. To meet various patient anatomical needs, the BPS Wrist Fractures several sizes of distal radius plates as well as various styles of locking, non-locking, and cortical bone screws. The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136.

    AI/ML Overview

    I'm sorry, but based on the provided FDA 510(k) clearance letter for the "BPS Wrist Fracture System," this device is a physical medical implant (a metallic bone fixation appliance) and not an AI or software-based medical device.

    Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not present in this document.

    The 510(k) summary explicitly states:

    • "The BPS Wrist Fracture System includes bone plate and bone screw implants designed for fixation of certain fractures, fusions, or osteotomies in the distal radius."
    • "The plates are manufactured from Commercially Pure Titanium Grade 4 per ASTM F67. The screws are manufactured from Titanium Alloy Grade 5 (Ti-6Al-4V ELI) per ASTM F136."
    • The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section only mentions "cleaning, sterilization, biocompatibility, mechanical and performance characteristics," which are typical for physical implants, not AI/software.

    None of the provided text suggests any AI or software component requiring the kind of study details you've asked for.

    To answer your specific questions related to AI/software, I would need a 510(k) clearance letter or similar documentation for an AI/software medical device.

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