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510(k) Data Aggregation

    K Number
    K192619
    Device Name
    Pitkar Locked Plating System
    Manufacturer
    S H Pitkar Orthotools Pvt Ltd.
    Date Cleared
    2020-02-27

    (157 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K153374,K013248,K030597,K062564,K033995,K011815,K012114,K073186
    Why did this record match?
    Device Name :

    Pitkar Locked Plating System

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

    Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

    Device Description

    The purpose of this submission is to request clearance for the new Pitkar Locked Plating System. The Pitkar Locked Plating System implants are designed to address fractures of the humerus, radius, ulna, femur, tibia, fibula, and clavicle. The system is comprised of plates, screws and instruments to facilitate the installation of the implants. The plates and screws are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

    AI/ML Overview

    This document is a 510(k) summary for the Pitkar Locked Plating System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for an AI/algorithm-based device.

    Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves an AI/algorithm-based device meets the acceptance criteria. The document describes a metallic bone fixation appliance, which is a physical medical device, not a software or AI product.

    The relevant sections of the document discuss:

    • Device Description: Plates, screws, and instruments manufactured from Titanium Alloy for fixation of fractures.
    • Performance Data (Nonclinical): This refers to mechanical testing of the physical implants, such as bend tests for plates and torsional/pull-out tests for screws, against ASTM standards. It also mentions biocompatibility.
    • Comparison to Predicate Devices: The rationale for substantial equivalence is based on similarities in design, materials, and sterilization to existing marketed devices.

    There is no mention of:

    • AI or algorithms
    • Test sets, training sets, or data provenance
    • Experts establishing ground truth for image analysis
    • Adjudication methods
    • Multi-reader multi-case (MRMC) studies
    • Standalone algorithm performance
    • Effect size of human readers with/without AI assistance

    In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and study proving an AI/algorithm-based device meets those criteria.

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