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Version: v2.0.1

Introduction

Purpose​

The purpose of this document is to provide instructions for the safe and effective use of the MySegmenter (v2.0.1).

Scope​

This document covers the usage and operation of the MySegmenter (v2.0.1) and provides important information for users.

Indications for use​

MySegmenter (v2.0.1) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room.

The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.

Intended Patients​

The MySegmenter (v2.0.1) is intended to be used only Adults (18+)

Intended users​

The MySegmenter (v2.0.1) should only be used by trained medical professionals, this includes:

  • Clinicians: These are medical professionals such as surgeons in the fields of orthopaedics, and craniomaxillofacial involved in the planning of treatments for clinical conditions.
  • Medical imaging technologist: Professionals in the development and research of solutions and academic researchers in the field of medical imaging.
  • Medical device designer: Professionals involved in the design of medical devices for treatment of orthopaedic and maxillofacial diseases.