(215 days)
Harmony Referral System (Harmony RS) is a comprehensive software platform intended for use in importing, processing, viewing, measurement and storage of clinical images and videos as well as in management and communication of patient data, diagnostic and clinical information and reports from ophthalmic diagnostic instruments through either direct connection with the instruments or through computerized networks. The system neither performs any interpretations nor provides treatment recommendations.
Harmony Referral System is an internet-browser-based software platform that allows users to access examination data of a patient from different sources. Harmony Referral System may be used together with a number of computerized digital imaging devices and third party software. In addition. Harmony Referral System software collects and manages patient demographics, image data, and clinical reports from a range of approved medical devices. Harmony Referral System enables a real-time review of diagnostic patient information at a PC workstation. The software uses SSL encryption in network communication and secure network infrastructure with firewalls and additionally also VPN and IP-based access restrictions to ensure secure networking environment. The Harmony Referral System does not perform automated image analysis but provides measurements based on pixels of an image, which were marked by the user manually on the screen including cup-disk ratio and line and area measurements.
The provided document, a 510(k) summary for the Topcon Harmony Referral System (Harmony RS), states that no performance data was required or provided for this device. Therefore, it is not possible to describe acceptance criteria or a study proving the device meets those criteria from this document.
The document explicitly states:
Performance Data
"No performance data was required or provided. Software validation and verification demonstrate that Harmony RS performs as intended and meets its' specifications."
And under the "Substantial Equivalence" section:
"The different technological characteristics of the devices do not raise new questions of safety and effectiveness. The differences in hardware requirements and system access are all system features that can be evaluated during software validation and verification and were primarily revised to allow the system to operate with newer hardware, browsers and operating systems."
This indicates that the FDA's clearance was based on demonstrating substantial equivalence to a predicate device (Topcon Harmony, K182376) and on software validation and verification, rather than a clinical performance study with defined acceptance criteria.
While the document details the device's intended use and technical specifications, it does not contain the information requested in the prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, or adjudication methods for performance evaluation.
§ 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).