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The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and Berchtold Surgical Lights. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The HERMES OR Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. The intent of the HERMES OR Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on the Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and Berchtold Surgical Lights in the Operating setting, or relying upon verbal communications between the surgeon and other personnel in the operation room in order to adjust surgical equipment.

The provided text describes a 510(k) premarket notification for the HERMES™ OR Control Center, a computer-driven system designed to allow surgeons to control medical device settings using voice commands.

However, the document does not contain information related to acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, etc.) as requested in the prompt. The text focuses on regulatory classification, indications for use, and substantial equivalence to a predicate device, along with adherence to various electrical and safety standards.

Therefore, I cannot fulfill the request to discuss the acceptance criteria and the study proving the device meets them based on the provided input.

The document lists various standards the device is designed and tested to, such as IEC 601-1, UL 2601-1, and EN standards for emissions and immunity. These are safety and electrical performance standards, not typically acceptance criteria for clinical efficacy or diagnostic accuracy.

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