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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.

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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, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.

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 for K132667 states: "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications."

Therefore, it is not possible to describe acceptance criteria or a study proving device performance based on the provided document. The device, Synergy ODM, is a software platform for image management in ophthalmology, and its 510(k) clearance was based on substantial equivalence to predicate devices, without requiring clinical performance data.

Ask a specific question about this device