Second Opinion® 3D

“Second Opinion® 3D is a radiological automated image processing software device intended to identify and mark clinically relevant anatomy in dental CBCT radiographs; specifically Dentition, Maxilla, Mandible, Inferior Alveolar Canal and Mental Foramen (IAN), Maxillary Sinus, Nasal space, and airway. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.”

“The cleared device is a software device, indicated for use by dental health professionals as an aid in reviewing CBCT radiographs. The device utilizes computer vision technology, developed using machine learning techniques, to identify clinically relevant anatomy on CBCT radiographs. Second Opinion® 3D consists of three parts: Application Programing Interface (“API”) Machine Learning Modules (“ML Modules”) Client User Interface (UI) (“Client”) The API sends imagery to the machine learning modules for processing and subsequently receives metadata generated by the machine learning modules which is passed to the interface for rendering. Second Opinion® 3D uses machine learning to identify areas of interest such as Individual teeth, including implants and bridge pontics; Maxillary Complex; Mandible; Inferior Alveolar Canal and Mental Foramen (defined as IAN); Maxillary Sinus; Nasal Space; Airway. Images received by the ML modules are processed yielding detections which are represented as metadata. Both devices use neural network-based computer vision algorithms for 3D modelling of patient anatomy.”

“Pearl developed Security controls and processes in accordance with FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions dated September 2023. These processes are used in both the development of Second Opinion® 3D and in post-market surveillance to ensure the product upholds the highest standards of privacy and security.”