(60 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 Dvonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, Smith & Nephew Dyonics® Power Shaver, and the Smith & Nephew Dyonics® 325Z DV Camera. 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 cholecystectorny, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection. laparoscopically assisted hvsterectomy. 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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document describes a 510(k) submission for a modification to the HERMES® O.R. Control Center. The provided text primarily focuses on regulatory compliance with various standards and provides limited detail on specific performance acceptance criteria or detailed study results beyond the fact that testing was conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several international and internal standards to which the device was tested. The "acceptance criteria" for these would typically be compliance with the requirements outlined in each standard. However, the document does not provide specific numerical performance metrics or acceptance thresholds for these tests, nor does it present the reported device performance values against such thresholds. It only states that the device "has been tested to the following standards."
Therefore, the table below reflects the tests performed, but the specific acceptance criteria and performance data are not detailed in the provided text.
| Test Title | Type of Standard/Test | Acceptance Criteria (from standard) | Reported Device Performance |
|---|---|---|---|
| IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, EN 60601-1, EN 60601-1-1 | Medical Electrical Equipment Safety | Compliance with general safety requirements | Not specified in document |
| UL 2601-1 | Underwriters Laboratory Safety | Compliance with general safety requirements | Not specified in document |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Safety | Compliance with general safety requirements | Not specified in document |
| EN55022/A1 (Conducted Emission) | Electromagnetic Compatibility (EMC) | Limits for conducted electromagnetic disturbances | Not specified in document |
| EN55022/A1 (Radiated Emission) | Electromagnetic Compatibility (EMC) | Limits for radiated electromagnetic disturbances | Not specified in document |
| EN61000-4-2 (Electrostatic Discharge) | Electromagnetic Compatibility (EMC) | Immunity levels to electrostatic discharge | Not specified in document |
| EN61000-4-3 and EN50140 (RF Immunity) | Electromagnetic Compatibility (EMC) | Immunity levels to radiated radio-frequency electromagnetic fields | Not specified in document |
| EN61000-4-4 (EFT/Bursts Immunity) | Electromagnetic Compatibility (EMC) | Immunity levels to electrical fast transient/bursts | Not specified in document |
| EN61000-4-5 (Surge Immunity) | Electromagnetic Compatibility (EMC) | Immunity levels to surge | Not specified in document |
| EN61000-4-6 (Conducted Immunity) | Electromagnetic Compatibility (EMC) | Immunity levels to conducted disturbances induced by RF fields | Not specified in document |
| EN 60601-1-2 (Emissions and Immunity Test Measurements) | Electromagnetic Compatibility (EMC) | Compliance with EMC requirements | Not specified in document |
| VA-24772 | CMI System Functional Testing | Internal criteria for system functionality | Not specified in document |
| CP-15345 | CMI Software Verification and Validation | Internal criteria for software quality and correctness | Not specified in document |
| VA-19795 | CMI Environmental Testing | Internal criteria for environmental robustness | Not specified in document |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on "sample size" in the context of test sets for performance evaluation (e.g., number of procedures, patients, or data points). The listed tests are primarily related to product safety, electrical compatibility, and internal functional/software verification. These types of tests typically involve physical units of the device or software code, rather than patient-derived data sets.
The data provenance is not applicable in the context of these engineering and safety tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of tests described. None of the listed tests require a "ground truth" established by medical experts in the way an AI diagnostic device would. The standards relate to safety, electrical, and software compliance.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of cases to establish ground truth for a diagnostic device. This is not relevant to the engineering and safety tests listed in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied by the listed tests. The device is a control center for surgical equipment, primarily offering voice control. The document describes it as "allowing for simplified and more direct control," but does not present a study comparing human reader performance with and without AI assistance for tasks like diagnosis or image interpretation.
6. Standalone Performance Study
The document does not describe a standalone performance study in the typical sense of evaluating an algorithm's performance on a dataset without human intervention. The "System Functional Testing" (VA-24772) and "Software Verification and Validation" (CP-15345) would involve evaluating the device's functions independently, but these are engineering verification tests, not clinical performance studies on patient data.
7. Type of Ground Truth Used
Given the nature of the listed tests (safety, electrical, environmental, software), the concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable. The "ground truth" for these tests would be defined by the specifications of the standards themselves (e.g., a certain level of electrical emission, a functional requirement, or a software behavior).
8. Sample Size for the Training Set
The document describes a modification to an existing device, the HERMES® O.R. Control Center, which primarily offers voice control for ancillary devices. The concept of a "training set" is typically associated with machine learning or AI models that learn from data. While the voice control aspect might involve some form of speech recognition that was "trained," the document does not provide any information regarding training sets, their size, or how they were used.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, this information is not provided. If voice recognition was involved, the "ground truth" for training would typically involve annotated audio data where spoken commands are correctly transcribed/labeled.
§ 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.