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The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is 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 cheleeystectomy, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, 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 users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

The HERMES Operating Room 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 intended use of the HERMES OR Control Center is a Voice Control system whose function is to allow for simplified and direct control of Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings by the surgeon, thereby eliminating the necessity of using multiple input interfaces now common in the operating room, or relying upon verbal communications between the surgeon and other personnel in the OR in order to adjust Stryker Endoscopy 882 Camera and Quantum 5000 Light Source.

The provided text is a 510(k) Premarket Notification for the HERMES OR Control Center System. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on a clinical study with detailed performance metrics and acceptance criteria in the way a research paper would.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone (algorithm only) performance
7. Type of ground truth used (e.g., pathology, outcomes data)
8. Sample size for the training set
9. How ground truth for the training set was established

Instead, the document focuses on:

• Device identification and intended use: The HERMES OR Control Center is a computer-driven system offering voice control for Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings. It's intended to simplify control and eliminate the need for multiple input interfaces or verbal communication to adjust settings during various endoscopic procedures like laparoscopy, thoracoscopy, and sinuscopy.
• Substantial equivalence: The device is claimed to be substantially equivalent to AESOP 510(k)'s K931783 and K960655, Model 882 Camera: K820624, and Quantum 5000 Light Source: K961971. This is the primary method of demonstrating safety and effectiveness for a 510(k) submission.
• Compliance with standards: The HERMES OR Control Center was designed and tested to several international and national standards for medical electrical equipment, including IEC 601-1, UL 2601-1, EMC Directive European Union 89/336/EEC, and CAN/CSA-C22.2. It also mentions "HERMES System Functional Test Requirements," but does not detail these requirements or results.
• Regulatory clearance: The FDA reviewed the 510(k) notification and determined the device to be substantially equivalent for the stated indications for use, thereby permitting it to be marketed.

In summary, this regulatory document for the HERMES OR Control Center does not provide the kind of detailed performance study information with explicit acceptance criteria, ground truth, and reader studies that would be found in a clinical trial report or a scientific publication. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant safety standards.

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