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510(k) Data Aggregation

    K Number
    K181587
    Device Name
    ORTHOLOC SPS Shoulder Plating System
    Manufacturer
    Tornier Inc.
    Date Cleared
    2018-10-05

    (112 days)

    Product Code
    HRS,HWC,KTT,KTW
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011815,K000684,K011335,K041860,K082625,K100146,K102352,K111432
    Predicate For
    K191711
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

    Device Description

    ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use.

    AI/ML Overview

    This document describes acceptance criteria and outlines performance testing for the ORTHOLOC™ SPS Shoulder Plating System. However, it does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria. Instead, it describes non-clinical bench testing for a physical medical device (bone plating system).

    Therefore, I cannot populate the requested table and answer the study-specific questions (2-9) about AI device performance, sample sizes, ground truth, experts, or MRMC studies.

    Here's the information that can be extracted from the provided text regarding the physical device and its testing:

    Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

    Acceptance Criteria CategorySpecific Test PerformedReported Device Performance / Conclusion
    Mechanical PerformancePlate Bending and Fatigue (to ASTM F382-17)Supports substantial equivalence to predicate devices.
    Screw Torsion, Driving Torque, and Axial Pullout (to ASTM F543-17)Supports substantial equivalence to predicate devices.
    Engineering Analysis of the Greater Tuberosity PlateSupports substantial equivalence to predicate devices.
    Cross Sectional Analysis comparing the subject and predicate platesSupports substantial equivalence to predicate devices.
    Safety and EffectivenessN/A (addressed by performance testing and comparison to predicates)Does not raise new questions of safety or effectiveness.
    Substantial EquivalenceComparison of technological characteristics with predicate devicesSubstantially equivalent in intended use, materials, design, and sterilization method to the predicate devices. Design differences do not raise new issues and are supported by performance testing.

    Regarding the study, based on the provided text:

    1. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical bench testing of a physical device, not an AI model.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    3. Adjudication method for the test set: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
    6. The type of ground truth used: Not applicable for an AI device. For the physical device testing, the "ground truth" would be established engineering standards (ASTM F382-17, ASTM F543-17) and comparative physical properties with predicate devices.
    7. The sample size for the training set: Not applicable. This is not an AI/algorithmic device.
    8. How the ground truth for the training set was established: Not applicable.
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