(90 days)
kneeEOS is a software indicated for assisting orthopedic surgeon in preoperative planning of knee orthopedic surgery. The software allows for overlaying of 3D/2D implants models on radiological images EOS based and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.
kneeEOS 1.0 allows surgeons to perform preoperative surgical planning of total knee arthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. The images displayed are x-rays from EOS System (K152788) and 3D model of the knee from sterEOS Workstation (K160914). kneeEOS also displays preoperative parameters and updated values of these parameters after planning. kneeEOS is accessible on any computer via ONEFIT Management System (Class I device - Product code LMD - 510(k) Exempt) that provides a secure internet interface and storage through authentication mechanisms.
The provided text is a 510(k) summary for the ONEFIT medical kneeEOS device. It describes the device, its intended use, and compares it to a predicate device (TraumaCad Release 2.0). However, the document does not contain explicit acceptance criteria, performance metrics, or details of a specific study to prove the device meets said criteria.
Instead, the document states that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This general statement indicates that testing was performed according to FDA guidelines for software in medical devices, but it does not provide the specific performance data requested.
Therefore, I cannot populate the table or answer the specific questions about the study from the provided text. The document concludes that the device is "as safe and effective as its predicate" based on "Performance data demonstrate that the kneeEOS is as safe and effective as its predicate," but these performance data are not detailed in this 510(k) summary.
§ 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).