(29 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 FXTM Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, and Smith & Nephew Dyonics® Power Shaver. 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 & 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 users of the HERMES O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
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 offer surgeons voice control for ancillary devices in the operating room. This system aims to simplify the control of medical device settings, eliminating the need for manual interfaces on various ancillary devices or verbal communication between the surgeon and other personnel.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Safety Standards (Electrical and Medical Equipment) | |
| IEC 601-1 (International Standard for Medical Electrical Equipment) | Device tested to this standard, indicating compliance with general safety requirements for medical electrical equipment. |
| IEC 601-1 Amendment 1 (International Standard for Medical Electrical Equipment) | Device tested to this standard, indicating compliance with an amendment to the general safety requirements. |
| IEC 601-2-18 (International Standard for Medical Electrical Equipment) | Device tested to this specific standard, likely related to the particular type of medical electrical equipment. |
| UL 2601-1 (Underwriters Laboratory) | Device tested to this standard, indicating compliance with UL safety requirements. |
| CAN/CSA-C22.2 No. 601.1 (Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1) | Device tested to this Canadian/CSA standard, indicating compliance with general safety requirements for medical electrical equipment. |
| EN60601-1 (International Standard for Medical Electrical Equipment) | Device tested to this European standard, indicating compliance with general safety requirements for medical electrical equipment. |
| EN60601-1-1 (General Requirements for Safety – Collateral Standard) | Device tested to this collateral standard, indicating compliance with specific safety aspects. |
| Electromagnetic Compatibility (EMC) | |
| EN55022/A1 (Conducted Emission) | Device tested for conducted emissions, indicating compliance with limits on electromagnetic interference generated and conducted through power lines. |
| EN55022/A1 (Radiated Emission) | Device tested for radiated emissions, indicating compliance with limits on electromagnetic interference generated and radiated into the environment. |
| EN61000-4-2 (Electrostatic Discharge) | Device tested for electrostatic discharge immunity, indicating its ability to withstand static electricity without malfunction. |
| EN61000-4-3 and EN50140 (RF Immunity) | Device tested for radiofrequency (RF) immunity, indicating its ability to operate correctly in the presence of RF electromagnetic fields. |
| EN61000-4-4 (EFT/Bursts Immunity) | Device tested for electrical fast transient/burst immunity, indicating its ability to withstand short-duration, high-frequency electrical bursts. |
| EN61000-4-5 (Surge Immunity) | Device tested for surge immunity, indicating its ability to withstand transient overvoltages. |
| EN61000-4-6 (Conducted Immunity) | Device tested for conducted immunity, indicating its ability to operate correctly in the presence of electromagnetic disturbances conducted through signal lines. |
| EN 60601-1-2 (Emissions and Immunity Test Measurements) | Device tested to this standard, indicating compliance with general requirements for EMC in medical electrical equipment. |
| Functional and Software Performance | |
| VA-24734 (CMI System Functional Testing) | Device underwent CMI System Functional Testing, demonstrating that the system performs its intended functions as specified. (Details of specific functions or metrics are not provided in the summary.) |
| CP-15345 (CMI Software Verification and Validation) | Device underwent CMI Software Verification and Validation, confirming that the software meets its specified requirements and is fit for its intended use. (Specific verification/validation metrics are not provided.) |
| Environmental Performance | |
| VA-19795 (CMI Environmental Testing) | Device underwent CMI Environmental Testing, demonstrating its ability to safely and effectively operate within specified environmental conditions (e.g., temperature, humidity). (Specific test parameters or results are not provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not contain information regarding:
- The sample size used for any specific test set.
- The data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The 510(k) summary does not contain information about:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
The tests conducted are primarily engineering and compliance-based (electrical safety, EMC, software verification, environmental testing), rather than clinical performance evaluations that would typically involve expert-established ground truth. The focus is on the device's adherence to recognized standards for safety and fundamental operation.
4. Adjudication Method for the Test Set:
Given the nature of the tests (compliance with IEC, UL, CSA, EN standards, functional testing), an adjudication method in the context of expert review for a "test set" (as might be seen in diagnostic AI) is not applicable or detailed in this summary. The tests involve quantifiable measurements against established standards, and functional checks against specification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
Based on the provided text, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The device is an O.R. control system, not a diagnostic imaging AI that would typically undergo such a study. The "AI" component is its voice control for ancillary devices, which is assessed for functionality and safety rather than diagnostic accuracy or comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The "HERMES® O.R. Control Center" is itself a standalone system (it functions independently as a computer-driven control center). The provided tests are evaluating the performance of this system as a whole, including its software, electronics, and voice recognition capabilities. There isn't a clear distinction made between "algorithm only" performance versus "human-in-the-loop," as the device's primary function is to serve the human surgeon. Its performance is its standalone capability to interpret voice commands and control ancillary devices.
7. The Type of Ground Truth Used:
For the compliance tests (IEC, UL, CSA, EN standards), the "ground truth" is the published requirements and limits defined by those international and national standards. For CMI System Functional Testing, Software Verification and Validation, and Environmental Testing, the "ground truth" would be the detailed specifications and design requirements internally defined by Computer Motion, Inc. for the HERMES system.
8. The Sample Size for the Training Set:
The 510(k) summary does not contain information regarding a "training set" or its sample size. This type of information is typically relevant for machine learning or AI models that learn from data, which is not explicitly discussed here in that context. While the voice recognition component undoubtedly involves some form of training, details are not provided.
9. How the Ground Truth for the Training Set Was Established:
As no specific training set is discussed, the summary does not provide information on how its ground truth might have been established. For any voice recognition components, ground truth during development would likely involve carefully curated voice commands and their corresponding intended actions, possibly recorded by various speakers in different conditions, and transcribed/labeled for training purposes. However, these specifics are beyond the scope of the provided 510(k) summary.
§ 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.