Recommendations

The following recommendations are suggested to maximize the effectiveness of the software:

• Engage with the training material provided by MySegmenter including user documentation and tutorial videos provided online.
• MySegmenter can be utilized by biomedical engineers, researchers, or personnel with equivalent training or experience as intended users. However, for diagnosis and planning purposes the device must be used in the conjunction with expert clinical professionals.
• The quality of medical images mainly determines the accuracy of the 3D model generated by MySegmenter. Specific Image acquisition protocols are left to user discretion; however, it is recommended to use updated industry standards; and only recent images should be use for the purposes described in the intended use.
• The device provides the most optimal results with datasets of good resolutions. A slice thickness and slice increment of 1 mm or less is recommended for diagnosis and planning decisions.