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SMART Bun-Yo-Matic X-Ray software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is X-ray. The SMART Bun-Yo-Matic X-Ray software provides: · Visualization report of the three-dimensional mathematical models of the anatomical structures of the foot and ankle and three-dimensional models of orthopaedic fixation devices. · Measurement templates containing radiographic measures of foot and ankle, · Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters. The visualization report containing the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the visualizations of the measurements in the context of three-dimensional models, orthopaedic fixation device models and surgical instrument parameters can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

The SMART Bun-Yo-Matic X-Ray device is a software tool that takes x-rays of the foot and produces 3D axes on contextual bone models to help a user plan for hallux valgus correction. The final output of the device is a case report that provides images of the patient's axes, as well as measurements prior to correction and following a surgical correction selected by the user.

SMART Bun-Yo-Matic CT software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is Computed Tomography (CT). SMART Bun-Yo-Matic CT software provides: · Visualization report of the three-dimensional mathematical models of the anatomical structures of foot and ankle and three-dimensional models of orthopaedic fixation devices, · Measurement templates containing radiographic measures of foot and ankle, · Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters. The visualization report containing the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the visualizations of the threedimensional structural models, orthopaedic fixation device models and surgical instrument parameters combined with the measurements can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

The SMART Bun-Yo-Matic CT device is an automatic software tool that segments foot and ankle bones from computed tomography (CT) images and provides a case report showing images of a 3D model of the segmented structures with pre-operative and post-correction measurements. The correction is for hallux valgus through a Lapidus Arthrodesis procedure. The case report also provides parameters of an orthopedic surgical instrument and an example of an implant construct for the procedure. The device includes machine learning derived outputs. Details on the validation are summarized below. The testing for 82 CT image series presented 100% correctly identified bones of foot and ankle. The existence of metal was identified correctly for 98.8% of the images (specificity 98%, sensitivity 100%).

Bonelogic software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. Bonelogic software provides: - Semi-automatic segmentation with manual or assisted input of bony structure identification from CT imaging input, - Three-dimensional mathematical models of the anatomical structures of foot and ankle, - Measurement templates containing radiographic measures of foot and ankle, and tools for manually obtaining linear and angular measurements, - Surgical planning application for foot and ankle using three-dimensional models of the anatomical structures and radiographic measures. The three-dimensional models of the anatomical structures combined with the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the three-dimensional structural models combined with the measurements can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

The Bonelogic is a software tool that segments bone anatomy using dedicated semiautomatic tools and fully automatic algorithms. More specifically, Bonelogic is intended to segment foot and ankle bones from computed tomography (CT) images. The segmented structures may then be used to create 3D models of their respective bones and replicate the anatomy of a patient. The semi-automatic tools of the software require a healthcare professional to mark the different bones in an initial 3D rendered model prior to when the segmentation process is initialized. This method is called the semi-automatic workflow with manual input. The software also comprises an optional semiautomatic workflow with assisted input that replaces the required user input with an estimate based on a locked artificial neural network (ANN) model. The fully automatic algorithm processes the final result in the same way based on input generated by the semi-automatic workflow with user input and with ANN model. The user still needs to mark the laterality and as a new step acknowledge the bones discovered by the ANN model.

Bonelogic software is intended to be used by specialized medical practitioners to assist in the characterization of human anatomy with 3D visualization and specific measurements. The medical image modalities intended to be used in the software are computed tomography (CT) images, cone beam computed tomography (CBCT) images and weight-bearing cone beam CT (WBCT) images. The intended patient population is adults over 16 years of age. Bonelogic software contains the measurement template with a set of distance and angular measurements can be used for diagnostic purposes. The three dimensional (3D) models are displayed and can be manipulated in the software. Together, the information from the measurements and the 3D visualization can be used for treatment planning in the field of orthopedics (foot and ankle, and hand wrist). The 3D models can be outputted from the software for traditional or additive manufacturing. The physical models generated based on the 3D digital models are not intended for diagnostic use.

Bonelogic product is a software tool to be used by specialized medical practitioners. The software tool is aimed to help the user in the characterization of human anatomy, and identifying possible trauma or deformities, the diagnose and the treatment planning should always be based on the professional skills of the specialist doctor. The medical image modalities intended to be used in the software are computed tomography (CT) images, cone beam computed tomography (CBCT) images and weight-bearing cone beam CT (WBCT) images. Bonelogic software has got a modular architecture. The software includes following functionality: - Importing medical images in DICOM format - Viewing of DICOM data - Selecting a region of interest using generic segmentation tools - Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms - Verifying and editing a region of interest - Calculating a digital 3D model and editing the model - Measuring on 3D models - Exporting images, measurements, and 3D models to third-party packages - Planning treatments on the 3D models - Interfacing with packages for Finite Element Analysis