(15 days)
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.
| Acceptance Criteria Category | Standard/Test | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL 2601-1, CAN/CSA-C22.2 No. 601.1 | Passed/Compliant with all specified electrical safety standards. |
| Electromagnetic Compatibility (EMC) | EN55022/A1 (Conducted Emission), EN55022/A1 (Radiated Emission), EN61000-4-2 (Electrostatic Discharge), EN61000-4-3 and EN50140 (RF Immunity), EN61000-4-4 (EFT/Bursts Immunity), EN61000-4-5 (Surge Immunity), EN61000-4-6 (Conducted Immunity), EN 60601-1-2 (Emissions and Immunity Test Measurements) | Passed/Compliant with all specified EMC standards, indicating no undue electromagnetic interference and robust operation in typical surgical environments. |
| System Functionality | VA-23763 (CMI System Functional Testing) | Performed as intended, demonstrating proper control of integrated devices and voice command recognition. (Details not provided in the summary) |
| Software Verification & Validation | CP-15345 (CMI Software Verification and Validation) | Software operated without critical errors and met design specifications. (Details not provided in the summary) |
| Environmental Testing | VA 19795 (CMI Environmental Testing) | Withstood specified environmental conditions (e.g., temperature, humidity) without operational failure. (Details not provided in the summary) |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.