(78 days)
Synergy ODM is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, clinical information, reports from ophthalmic diagnostic instruments through either a direct comection with the instruments or through computerized networks.
Synergy ODM is a modification to Synergy ODM cleared in K132667. The key differences between the cleared product and the one that is the subject of this 510(k) are minor modifications to the GUI. addition of a mobile GUI. minor workflow enhancements, additional measurements based on existing line and area measurement tools, minor enhancements to the data acquisition and export functionality, addition of two new reports, minor enhancements to external access to Synergy ODM, performance enhancements to decrease start up time, enhancement to external interfaces, changes to configuration options and tools which are not accessible to the end user, modifications required to maintain compatibility with external products, modification to tools which are not accessible to the user, and bug fixes.
Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition. Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.
The provided text describes a 510(k) premarket notification for the "Synergy ODM" device. It is a software platform for managing ophthalmic images and patient data. However, the document explicitly states that "No performance data was required or provided." Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.
Here's why I cannot fulfill your request based on the provided text:
- No performance data: The critical sentence "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications" indicates that the regulatory submission did not include a study with performance metrics against acceptance criteria.
- Substantial Equivalence: The submission focuses on demonstrating "Substantial Equivalence" to a predicate device (Topcon Corporation Synergy ODM, K132667) rather than proving performance against novel acceptance criteria. This means the device is considered safe and effective because it is very similar to an already approved device, not because a new clinical performance study was conducted.
Since the document explicitly states no performance data was provided, I cannot generate the requested table or answer the other questions about acceptance criteria and study details. The device's approval was based on demonstrating substantial equivalence to a predicate device, not on a new performance study.
§ 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).