(60 days)
The HERMES™ Control Center is indicated for use with Stryker Endoscopy 882 Camera. Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and AESOP®3000HR (HERMES-Ready). 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 hemia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic 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 is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The HERMES™ Control Center is a computer-driven system whose basic function is to offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. The intent of the HERMES™ 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 the Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and AESOP®3000HR in the Operating setting, or relying upon verbal communications between the surgeon and other personnel in the operation room in order to adjust surgical equipment.
The provided text describes the HERMES™ OR Control Center System with AESOP® 3000HR, but it primarily focuses on its regulatory submission for 510(k) clearance and general device information. It does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen in performance testing reports.
The document details safety and effectiveness summaries, product classification, and FDA clearance, but it lacks the granular data expected for answering questions about detailed performance studies.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document lists general manufacturing and safety standards (IEC, UL, EN, CAN/CSA) to which the device is designed and tested, but these are not performance-based acceptance criteria with corresponding device performance metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device's function is to offer voice control for parameter settings, not to assist with diagnostic interpretation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Summary of available information:
- Device Name: HERMES™ Operating Room Control Center with AESOP® 3000HR
- Purpose: To offer surgeon selection of attachment device parameter settings using voice control, simplifying control of medical device settings and eliminating the need for manual adjustments or verbal communication with other personnel.
- Predicate Devices: HERMES Operating Room Control Center and Accessories (K990691) and AESOP®3000 (K972699).
- Standards Met (design and testing): IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL 2601-1, Conducted & Radiated Emission EN55022/A1: 1995 Immunity Tests EN61000-4-2: 1995; EN61000-4-3: 1995; EN50140:1994; EN61000-4-4:1995; EN61000-4-5:1995; EN61000-4-6:1995, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92.
- Indications for Use: Used with specific Stryker and W.O.M. equipment in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated. Examples include laparoscopic cholecystectomy, hernia repair, appendectomy, hysterectomy, spinal fusion, lung biopsy, and cardiac procedures requiring endoscopic visualization.
- Users: General surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.
- Regulatory Clearance: 510(k) substantial equivalence to predicate devices granted by the FDA on June 25, 1999 (K991444).
To answer the specific questions posed, a different type of document, such as a detailed test report or a clinical study report, would be required. The provided text is primarily a regulatory summary for 510(k) clearance.
§ 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.