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The HERMES™ 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 AESOP®3000HR (HERMES-Ready). 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 hemia repair, laparoscopic appendectomy, 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™ Control Center is a computer-driven system whose basic function is to offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. The intent of the HERMES™ 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 AESOP®3000HR 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 the HERMES™ OR Control Center System with AESOP® 3000HR, but it primarily focuses on its regulatory submission for 510(k) clearance and general device information. It does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen in performance testing reports.

The document details safety and effectiveness summaries, product classification, and FDA clearance, but it lacks the granular data expected for answering questions about detailed performance studies.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists general manufacturing and safety standards (IEC, UL, EN, CAN/CSA) to which the device is designed and tested, but these are not performance-based acceptance criteria with corresponding device performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device's function is to offer voice control for parameter settings, not to assist with diagnostic interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

• Device Name: HERMES™ Operating Room Control Center with AESOP® 3000HR
• Purpose: To offer surgeon selection of attachment device parameter settings using voice control, simplifying control of medical device settings and eliminating the need for manual adjustments or verbal communication with other personnel.
• Predicate Devices: HERMES Operating Room Control Center and Accessories (K990691) and AESOP®3000 (K972699).
• Standards Met (design and testing): IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL 2601-1, Conducted & Radiated Emission EN55022/A1: 1995 Immunity Tests EN61000-4-2: 1995; EN61000-4-3: 1995; EN50140:1994; EN61000-4-4:1995; EN61000-4-5:1995; EN61000-4-6:1995, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92.
• Indications for Use: Used with specific Stryker and W.O.M. equipment in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated. Examples include laparoscopic cholecystectomy, hernia repair, appendectomy, hysterectomy, spinal fusion, lung biopsy, and cardiac procedures requiring endoscopic visualization.
• Users: General surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
• Regulatory Clearance: 510(k) substantial equivalence to predicate devices granted by the FDA on June 25, 1999 (K991444).

To answer the specific questions posed, a different type of document, such as a detailed test report or a clinical study report, would be required. The provided text is primarily a regulatory summary for 510(k) clearance.

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