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510(k) Data Aggregation

    K Number
    K234009
    Device Name
    Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
    Manufacturer
    Mighty Oak Medical
    Date Cleared
    2024-07-12

    (206 days)

    Product Code
    QIH,LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K183105,K183489
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Acorn Segmentation is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file. Acorn Segmentation is also intended for measuring and treatment planning. The Acorn Segmentation output can also be used for the fabrication of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.

    Acorn Segmentation and 3DP Models should be used in conjunction with expert clinical judgment.

    Device Description

    Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn Segmentation for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn Segmentation is structured as a modular package. This includes the following functionality:

    • Importing medical images in DICOM format
    • Viewing images and DICOM data
    • Selecting a region of interest using generic segmentation tools
    • Segmenting specific anatomy using dedicated semi-automatic tools or automatic algorithms
    • Verifying and editing a region of interest
    • Calculating a digital 3D model and editing the model
    • Measuring on images and 3D models
    • Exporting 3D models to third-party packages

    Acorn Segmentation contains both machine learning based auto-segmentation as well as semi-automatic and manual segmentation tools. The auto-segmentation tool is only intended to be used for thoracic and lumbar regions of the spine (T1-T12 and L1-L5). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal and craniomaxillofacial anatomy.

    Acorn 3DP Model is an additively manufactured physical replica of the digital 3D model generated in Acorn Segmentation. The output file from Acorn Segmentation is used to additively manufacture the Acorn 3DP Model.

    AI/ML Overview

    The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX).

    Here's the breakdown:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Metric)Target Acceptance CriteriaReported Device Performance
    Geometric accuracy of digital models (Dice-Sorensen Coefficient) - Automatic Segmentation (Thoracic and Lumbar spine)Average Dice-Sorensen Coefficient ≥ 0.93Average Dice-Sorensen Coefficient > 0.93
    Geometric accuracy of digital models (Dice-Sorensen Coefficient) - Semi-automatic and Manual Segmentation (Musculoskeletal & Craniomaxillofacial bone)Average Dice-Sorensen Coefficient ≥ 0.93Average Dice-Sorensen Coefficient > 0.93
    Geometric accuracy of physical replicas (Mean Deviation)Mean Deviation
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