(22 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™ Electro-surgical 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, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew 400 Insufflator. 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 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 providing voice control for ancillary devices in surgical settings.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 601-1 (Medical Electrical Equipment) | Compliant |
| IEC 601-1 Amendment 1 | Compliant |
| IEC 601-2-18 | Compliant |
| UL 2601-1 (Underwriters Laboratory) | Compliant |
| CAN/CSA-C22.2 No. 601.1 (Medical Electrical Equipment Part 1, General Requirements for Safety) | Compliant |
| EN55022/A1 (Conducted Emission) | Compliant |
| EN55022/A1 (Radiated Emission) | Compliant |
| EN61000-4-2 (Electrostatic Discharge) | Compliant |
| EN61000-4-3 and EN50140 (RF Immunity) | Compliant |
| EN61000-4-4 (EFT/Bursts Immunity) | Compliant |
| EN61000-4-5 (Surge Immunity) | Compliant |
| EN61000-4-6 (Conducted Immunity) | Compliant |
| EN60601-1 (International Standard for Medical Electrical Equipment) | Compliant |
| EN60601-1-1 (General Requirements for Safety - Collateral Standard) | Compliant |
| EN 60601-1-2 (Emissions and Immunity Test Measurements) | Compliant |
| VA-24772 (CMI System Functional Testing) | Completed and verified |
| CP-15345 (CMI Software Verification and Validation) | Completed and verified |
| VA-19795 (CMI Environmental Testing) | Completed and verified |
2. Sample Size Used for the Test Set and Data Provenance
The provided document details various engineering and safety standards (e.g., IEC, EN, UL, CAN/CSA) and internal company tests (CMI System Functional Testing, Software Verification and Validation, Environmental Testing). These types of tests typically involve controlled laboratory environments and specific test configurations, rather than human subject test sets with "data provenance" in the sense of patient data. Therefore, the concept of sample size and data provenance (country of origin, retrospective/prospective) for clinical test sets is not applicable to the data presented in this submission, as it focuses on demonstrating compliance with technical and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests performed are primarily engineering and hardware/software verification and validation, which rely on defined test procedures and specifications rather than expert consensus on clinical ground truth.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the types of engineering and safety tests outlined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted, as the submission focuses on the safety and effectiveness of a control system for medical devices, not on the interpretation of medical images or data by human readers. The device aims to simplify control during surgery, not to aid in diagnostic or interpretive tasks where an MRMC study would be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The submission describes device testing in terms of compliance with various technical and safety standards (e.g., electrical safety, EMC, software functionality). These demonstrate the algorithm's functionality and performance in a standalone capacity within the system's design parameters. However, it's important to note that the device's intended use is inherently with a human operator (the surgeon) in the loop, as it provides "voice control for ancillary devices" and aims to eliminate "relying on verbal communications between the surgeon and other personnel." The described tests verify the technical integrity of the standalone components. While the performance of the voice control algorithm itself would have been tested, the document does not break down specific "standalone algorithm performance" metrics separate from the broader system functional tests (e.g., VA-24772, CP-15345).
7. Type of Ground Truth Used
The ground truth for the various tests appears to be:
- Established industry standards and regulations: For tests like IEC, UL, EN, and CAN/CSA, the ground truth is compliance with the specified requirements and limits defined in those standards.
- System specifications and design documents: For CMI's internal functional, software, and environmental testing (VA-24772, CP-15345, VA-19795), the ground truth would be predetermined performance specifications, design requirements, and expected operational parameters of the HERMES® O.R. Control Center.
8. Sample Size for the Training Set
This information is not provided and is not applicable. The HERMES® O.R. Control Center is a control system that seems to rely on voice recognition and device integration. While a voice recognition component would historically have a training set, the submission does not detail its development or any machine learning training sets. Instead, the focus is on the safety, electrical, and functional performance of the integrated system.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable.
§ 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.