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510(k) Data Aggregation

    K Number
    K250290
    Device Name
    SurgiTwin
    Manufacturer
    Twinsight
    Date Cleared
    2025-08-29

    (210 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K240926
    Why did this record match?
    Device Name :

    SurgiTwin

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

    SurgiTwin is a web-based platform designed to help healthcare professionals carry out pre-operative planning for knee reconstruction procedures, based on their patients' imported imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning.

    The system works with a database of digital representations related to surgical materials supplied by their manufacturers. SurgiTwin generates a PDF report as an output. End users of the generated SurgiTwin reports are trained healthcare professionals. SurgiTwin does not provide a diagnosis or surgical recommendation.

    Device Description

    SurgiTwin is a semi-automated Software as a Medical Device (SaMD) that assists health care professionals in the pre-operative planning of total knee replacement surgery. Using a series of algorithms, the software creates 2D segmented images, a 3D model, and relevant measurements derived from the patient's pre-dimensioned medical images. The software interface allows the user to adjust the plan manually to verify the accuracy of the model and achieve the desired clinical targets. SurgiTwin generates a PDF report as an output. SurgiTwin does not provide a diagnosis or surgical recommendation.

    The intended patient population is patients over 22 undergoing total knee replacement surgery without any existing material in the operated lower limb.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for SurgiTwin:

    1. Acceptance Criteria and Reported Device Performance

    The provided document specifically details acceptance criteria for the segmentation ML model. Other functions (automatic landmark function, metric generation, implant placement, osteophyte removal) are mentioned as having "predefined clinical acceptance criteria" and "all acceptance criteria were met," but the specific numeric criteria are not listed.

    Table of Acceptance Criteria (for the Segmentation ML Model) and Reported Device Performance:

    MetricAcceptance CriteriaReported Device Performance
    Mean DSC (Dice Similarity Coefficient)> 0.95Met (> 0.95, implied by "met the acceptance criteria")
    Mean voxel based AHD (Average Hausdorff Distance)0.9Met (> 0.9, implied by "met the acceptance criteria")
    95th percentile of the boundary based HD 95 (Hausdorff Distance 95th percentile)
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