NBIR Device Tracking vs Dynamic3DFaceAsymmetryApp

The NBIR Device Tracking App is a HIPAA-compliant app that can be used to quickly capture data that is required for the purposes of device tracking – a federally-mandated requirement of manufacturers of breast implants. This means physicians can simultaneously fulfill their device tracking requirements for Allergan, Mentor and Sientra by participating in the NBIR. The app uses OCR technology to scan and capture data from patient demographic forms and breast implant device barcodes. Captured data is securely packaged in a case report form and submitted to NBIR. The NBIR is a collaboration between The Plastic Surgery Foundation, the FDA, and breast implant device manufacturers for the purpose of strengthening the post-market surveillance infrastructure for current and future breast implant devices. For more information, please visit thepsf.org/NBIR

Facial symmetry means that both sides of the face, right and left, are alike on median sagittal plane. The term “Facial asymmetry” refers to imbalance of an individual’s facial features on either side of their face. Facial asymmetry is quantified by means of 3D-photography based measurements. Methods available for clinicians to identify and assess facial asymmetry of three-dimensional (3D) ones, are stereo photogrammetry, laser scanning and contact digitalisation but are expensive time consuming methods and not easily available. App take advantage of iPhone’s trueDepth front camera and take surface scans of subjects’ faces continuously. TrueDepth camera provides depth data in real time allowing stereo photogrammetry imaging. A wireframe texture of grid lines appears over user’s face matching the size, shape, topology of the user's face in real time. Total of 1220 unique anthropometric topographical landmarks of face (ID number) points are automatically and continuously captured over face surface. 587 points left, 587 points right and 46 points in midline saggital plane face.The distances and differences of points to sagittal, frontal, transverse plane from right and to left side are calculated for each unique pair of anthropometric topographical landmarks of face. Mean difference of distances of anthropometric landmarks points toward one side right or left are depicted over face’s side with colour respectively, namely differences less than 1 mm in green colour (symmetric), between 1 to 2 mm in yellow colour and over 2 mm, points are depicted in red colour (asymmetric). App offers : -dynamic measurements in real time of face symmetry. Coloured anthropometric topographical landmarks over 3D face’s wire frame give information continuously about the degree and the direction of asymmetry left or right respectively helping to identify easily the affected region of face. -quantitative assessment of face asymmetry allows to assess the severity of the side and region of asymmetry and place it within or outside the range of normative. Asymmetry index AI, face dominance left or right, average distances from the left side in mm (AvgL), average distances from the right side in mm (AvgR) and maximum distances difference from symmetric nodes of the two sides are being calculated (MaxDiff) in all planes. Disclaimer. Regarding its plausibility app offers no diagnosis or treatment. App provide an early indication that further evaluation may be warranted by Speciality Doctor. Algorithm in App detects in surface Irregularity between left and right site of the face. Explicitly is announced that the app is not for diagnosis. Clinical judgment and experience are required to properly use the software. App alone do not replace an M.D. or specialist. All information received from the App output must be reviewed before any attempted treatment. The software is not for primary image interpretation. Any influence to the operators in making decisions remains user own responsibility and experience. App does not dispense medical advice. App is intended solely for personal use. By using apps personal data are not collected in any form for use, store, disclosure, sharing, and retention of any data by third party or in iCloud. In case during App use,  user collects personal data  from others individuals must have the individuals consent to the collection in accordance with Privacy Policy and terms of services of the user. Obtaining explicit consent from subject using the App is mandatory and obligation of the user.     Data gathered from facial mapping tools (e.g. ARKit, Camera APIs, or Photo APIs) should not be used for marketing, advertising or use-based data mining, including by third parties. Unauthorised use, disclosure or access by third parties is strongly prohibited and If a user ceases to consent or affirmatively revokes consent must promptly cease all such use.