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The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems.

The Optos Advance Software is a web-based software system application intended for use in storing, managing, and displaying patient data, diagnostic data, videos and images from computerized diagnostic instruments or video documentation systems. The Optos Advance Software is an image review application that allows the user to view DICOM compatible images. The Optos Advance Software organizes the digitized images into studies and sessions. The digitized studies and sessions may be viewed by using an overall or bilateral display (i.e., display provides comparisons between old and new images). The software also allows physicians or technicians to create on-line notes with the ability to zoom in or out (i.e., enlarge or decrease magnification of images) and annotate such images with arrows or text boxes to highlight areas the user determines by training and experience to be of interest. The Optos Advance Software does not automatically highlight, annotate, or otherwise alter the images. In addition, the digitized studies and sessions and on-line notes may be viewed, archived on a central file server, or electronically shared in a secure manner with other health care professionals. The Optos Advance Software allows the user to interface a Scanning Laser Ophthalmoscope, Fundus Camera, OCT or other DICOM compliant diagnostic camera with the Optos Advanced Software via a secure network connection to the Optos Advance Server. The server has a watchdog service which processes the DICOM information sent via the network. The information is then processed and placed in local storage on the Optos Advance Server. The data is obfuscated at the server side to protect any patient information transferred. The Optos Advance Software does not require any customized software installed on the client PC. The images, annotations and DICOM data are all stored on the Optos Advance Server, which handles the archiving, reporting, and retrieval of the data. This server can be set up remotely over an HTTPS connection which allows secure remote transfer of the stored data for archive purposes.

The provided text describes a 510(k) summary for the Optos Advance Software. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general software verification and validation.

The document explicitly states:

• "A full software and system verification and validation was performed as per the Software Development Lifecycle Process in Optos PLC." This is a general statement about standard software development practices, not a detailed performance study with acceptance criteria and results.
• The comparison to the predicate device (Carl Zeiss Surgical GmbH FORUM Software) is based on "substantially similar indications for use" and "minor differences in technological characteristics...raise no new questions of safety and effectiveness." This is an argument for substantial equivalence, not a direct performance study comparing the device against specific metrics.

Therefore, I cannot provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, or details about MRMC or standalone studies. The document does not contain this type of information.

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