(171 days)
The Surgimap Spine software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as spine related measurements of the images, to plan surgical procedures (osteotomies), and includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Surgimap Spine is a software solution developed for the medical community. It is intended to be used to view, store, and transport images as well as perform spine related measurements and plan surgical procedures. The image formats supported encompass the standard image formats (jpeg, tiff, png, ....) and also the DICOM images. Images can be stored in a database and measurements (generic or spine specific) can be overlaid to each image. Surgimap Spine also offers the ability for the end user to plan certain surgical procedures such as osteotomies of the spine and templating generic implants (screws and interbody cages). SurgiSmap Spine is a standalone application developed for windows environment. Surgimap Spine can be downloaded directly from www.surgimap.com via the Internet and run off a digital storage such as USB or personal computer hard drive
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Surgimap Spine) and includes general information such as contact details, device description, intended use, and a comparison with a predicate device. It explicitly states "Performance data. Not Applicable."
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).