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Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.

The Surgery Image Recorder (SIR) is an acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures. The SIR is designed to provide surgeons the ability to capture still images and streaming video from standard video outputs typically associated with imaging devices used during endoscopic surgery. To allow for the entry of patient demographic information and to provide a user interface the SIR will have and VO for a USB type keyboard and mouse, and will also provide I/O's for a USB compatible color printer, video outputs, serial outputs and network connectivity. Additionally, the SIR will be able to store data to its internal hard disk drive and to removable storage media (e.g., DVD, CD-R).

The provided 510(k) summary for the Camtronics Surgery Image Recorder (SIR) states that performance data is "Not required for determination of substantial equivalence for this class of device." It also states, "Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for device performance evaluation is present in the document. The device was deemed substantially equivalent to a predicate device based on comparison of technological characteristics and intended use, not on specific performance metrics or clinical study outcomes.

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