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The Dyonics Vision 635 Image Management System - HERNES™-Ready is designed to be used to capture intraoperative still and motion images using the camera head, the optional footswitch, the front panel of the system, the keyboard, or with optional voice-activated of touch panel control via HERMES. Images are then stored in one of several standard image formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.
To capture intraoperative still and motion images.

The Dyonics Vision 635 Image Management System (DV 635) is designed to provide surgeons the ability to capture still images and motion video during surgical procedures in various file formats for archival and presentation purposes. The DV 635 connects to any device with standard video outputs via standard video connections, and provides video throughput to video monitors, and other video peripheral devices. The DV 635 utilizes an external keyboard for input of basic patient and case information, and to set the system configuration. To capture images, the DV 635 utilizes user inputs from front panel switches, camera head buttons, the keyboard, optional footswitch, or optional voiceactivated or touch panel central control via HERMES™. Images and motion video clips are stored on an internal hard disk drive, and later transferred to a removable storage media, including CD-R and ZIP™ disks, or to an network drive or printer via a Ethernet connection. The DV 635 may also print images directly to a postscript printer via a print server.

The provided document is a 510(k) summary for the Dyonics Vision 635 Image Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with various safety standards. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to image quality or diagnostic accuracy.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on regulatory compliance and the device's technical specifications, not on clinical performance evaluation against specific metrics.

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