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The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, and Skytron Stellar Series O.R. 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 hysterectorny, laparoscopic & thoracoscopic 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. 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 ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.

The HERMES® O.R. Control Center is a computer-driven system designed to provide surgeons with voice control over ancillary medical devices, thereby simplifying device adjustments and reducing reliance on manual interfaces or verbal communication with other operating room personnel.

Here's an overview of its acceptance criteria and the studies performed:

1. Acceptance Criteria and Reported Device Performance:

The provided document lists several international and internal standards the device was tested against. It doesn't explicitly state quantitative performance metrics or acceptance thresholds for these in a comparative table format. Instead, it indicates compliance with these standards.

2. Sample Size for Test Set and Data Provenance:

The document does not specify a sample size for a "test set" in the context of clinical performance or diagnostic accuracy. The tests listed are primarily engineering and compliance standards (e.g., electrical safety, EMC, software verification), which typically involve testing the device itself against predefined specifications rather than a set of patient data.

3. Number of Experts for Ground Truth and Qualifications:

This information is not applicable and not provided in the document as the device is a control system, not a diagnostic or AI-driven system requiring expert-established ground truth for image or data interpretation.

4. Adjudication Method for Test Set:

This information is not applicable and not provided as the device is a control system, not a diagnostic or AI-driven system requiring adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted and is not applicable for this device. The HERMES® O.R. Control Center is a device control system, not an AI-assisted diagnostic tool that would improve human reader performance. Its purpose is to simplify control of other surgical devices, not to aid in diagnosis or interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-loop):

The concept of "standalone performance" as it pertains to an algorithm interpreting data does not directly apply here. The HERMES system's core function is voice control, which is inherently a human-in-the-loop interaction. However, the "CMI System Functional Testing" (VA-23763) and "CMI Software Verification and Validation" (CP-15345) would assess the device's internal algorithms and functionalities independently of a surgeon's specific use case, ensuring it accurately recognizes commands and sends correct signals. The document does not provide specific metrics from these tests.

7. Type of Ground Truth Used:

The "ground truth" for this device would be tied to its functional performance and compliance with engineering standards:

• Compliance with International Standards: The device's operation was measured against the established parameters and requirements of standards like IEC 601-1 for electrical safety, and EN series for EMC.
• Design Specifications: For internal functional testing and software validation, the "ground truth" would be the predefined design specifications and expected behavior of the system, such as accurately interpreting voice commands and correctly controlling integrated medical devices.

The document does not refer to clinical outcomes, pathology, or expert consensus in the same way a diagnostic AI might.

8. Sample Size for Training Set:

This information is not provided and is not directly applicable in the context of traditional machine learning training sets. While the voice recognition component would have been developed using a dataset, this document focuses on regulatory compliance and does not detail the development process of the voice recognition module.

9. How Ground Truth for Training Set was Established:

This information is not provided. If voice recognition software was indeed a core component that required training, the ground truth for that training data would typically involve annotated audio samples where specific voice commands are correctly labeled with their intended actions. However, the document provided does not delve into the specifics of the voice recognition training.

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