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The Dyonics Vision 635 Digital Capture System is indicated to be used in the operating room to digitally capture intra-operative still and motion images using the camera head, the foot switch, the front panel of the capture unit or the keyboard. Images are then stored in one of several standard image file formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.

The Dyonics Vision 635 Digital Capture 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 or optional footswitch. 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 text describes the Dyonics Vision 635 Digital Capture System. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for substantiating device claims.

The document is a 510(k) summary for a medical device which focuses on outlining the device's administrative information, description, intended use, and a comparison to a predicate device for demonstrating substantial equivalence to the FDA. It explicitly states that "These changes do not impact the safety or efficacy of the device," suggesting that a detailed performance study like what you're asking for was not deemed necessary for this particular 510(k) clearance due to its nature as an image capture and storage system with features similar to a predicate device.

Therefore, I cannot fulfill your request for the tables and study details because that information is not present in the provided text.

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