(84 days)
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic retinal cameras.
The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.
The Ophthalmic Software Platform RX consists of three types of software including the RX Capture for Retinal Camera, RX Server and RX Viewer.
RX Capture for Retinal Camera software: This is a software executed on a Capture PC. This software acquires images from a retinal camera that the control software captures and puts on the Capture PC. This software acquires images of eye, stores images and processes images. Also, this software displays acquired and processed images which are stored in a Server's database.
RX Viewer software: This is a software executed on a Viewer PC. This software processes images and displays acquired and processed images which are stored on the RX Capture for Retinal Camera or RX Server's database.
RX Server software: This is a software executed on a Viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in its' own database.
This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary for the Ophthalmic Software Platform RX, which details its substantial equivalence to a predicate device (Topcon IMAGEnet 5 PC Software System - K132438).
The document focuses on demonstrating that the new device has:
- The same intended use.
- Similar indications for use.
- Similar principles of operation.
- Similar technological characteristics.
Therefore, it concludes that the Ophthalmic Software Platform RX is as safe and effective as its predicate device. The information provided is typical for a 510(k) submission, which aims to demonstrate substantial equivalence rather than provide a detailed performance study with acceptance criteria.
Specifically, the document states:
- "Software verification and validation testing was 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.' The software for this device was considered as a 'moderate' level of concern." (Page 5, Section i. Software Verification and Validation)
This statement indicates that V&V was performed according to general FDA guidance for software, but it does not provide the specific acceptance criteria, method of testing, or results of a study that would address the information requested regarding device performance.
Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text.
§ 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).