(435 days)
ZedView is indicated for pre-operative planning and post-operative evaluations for various surgical procedures such as artificial joint replacement (arthroplasty), osteotomy, trauma, deformity correction.
ZedView is a software package that provides computer-assisted 3D planning and evaluations using 2D image data in DICOM or other formats, for various pre-operative surgical procedures and post-operative evaluations. The software is composed of various modules described below.
The provided text is a 510(k) summary for ZedView ver.14.0. It defines the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics, especially in the context of an AI/ML device.
The document explicitly states: "6.8 Clinical Performance Test Summary: None." This indicates that no clinical performance tests (which would typically involve evaluating the device against acceptance criteria) were performed or submitted.
The submission focuses on demonstrating substantial equivalence based on similar device specifications, operational principles, technical characteristics, and intended use as its predicate device, ZedView (K133022), rather than providing performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.
If this were a different type of submission (e.g., a De Novo request for a novel AI/ML device), or if the 510(k) summary had included detailed performance testing, then such information would be available.
§ 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).