(19 days)
The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SES Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump. and the Stryker Total Performance System (endoscopy port only). 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 symph node dissection, laparoscopically assisted hysterectomy, laparoscopic 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 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 Operating Room Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.
The intent of the HERMES OR 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, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump and the Stryker Total Performance System (endoscopy port only) 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 HERMES™ Operating Room Control Center is a computer-driven system that allows surgeons to control medical device settings using voice commands.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
This 510(k) summary does not include a table of specific acceptance criteria with corresponding device performance metrics (e.g., accuracy, precision, sensitivity, specificity). Instead, it primarily focuses on demonstrating that the HERMES™ Operating Room Control Center conforms to established safety and electrical standards.
The document lists the following standards to which the device was designed and tested:
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| IEC 601-1 Second Edition 1990 Medical Electrical Equipment | Device was designed and tested to this standard. |
| IEC 601-1 Second Amendment 1 1991 Medical Electrical Equipment | Device was designed and tested to this standard. |
| IEC 601-2-18 First Edition 1990 Medical Electrical Equipment | Device was designed and tested to this standard. |
| UL 2601-1 | Device was designed and tested to this standard. |
| Conducted & Radiated Emission EN55022/A1: 1995 | Device was designed and tested to this standard. |
| Immunity Tests EN61000-4-2: 1995 | Device was designed and tested to this standard. |
| Immunity Tests EN61000-4-3: 1995 | Device was designed and tested to this standard. |
| Immunity Tests EN50140:1994 | Device was designed and tested to this standard. |
| Immunity Tests EN61000-4-4:1995 | Device was designed and tested to this standard. |
| Immunity Tests EN61000-4-5:1995 | Device was designed and tested to this standard. |
| Immunity Tests EN61000-4-6:1995 | Device was designed and tested to this standard. |
| CAN/CSA-C22.2 NO. 601 | Device was designed and tested to this standard. |
Study Details:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the way one might expect for diagnostic AI or imaging devices.
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Sample size for the test set and data provenance:
The document does not specify a "test set" in the context of clinical performance data (e.g., patient data, image dataset). The testing refers to compliance with electrical and safety standards. Therefore, information on sample size and data provenance for a test set in the traditional sense is not applicable or provided. -
Number of experts used to establish the ground truth for the test set and qualifications:
Not applicable, as the provided document focuses on compliance with engineering and safety standards, not on clinical performance or diagnostic accuracy that would require expert-established ground truth. -
Adjudication method for the test set:
Not applicable, for the reasons stated above. -
Multi-reader multi-case (MRMC) comparative effectiveness study:
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This device is an operating room control system for device settings, not a diagnostic or AI-assisted interpretation tool that would typically involve MRMC studies. -
Standalone (algorithm only without human-in-the-loop performance) study:
While the system operates on voice control, the "standalone" performance isn't described in terms of a clinical outcome or diagnostic accuracy. Its performance is measured by its ability to reliably and correctly interpret voice commands to adjust device parameters according to the surgeon's intent, and its compliance with safety standards. The document doesn't provide specific data on voice recognition accuracy or response time for device control. -
Type of ground truth used:
The "ground truth" for this device's performance testing revolved around engineering standards and functional requirements. For example, whether it correctly changed a setting when a specified voice command was given, or if it met electromagnetic compatibility limits. It is not expert consensus, pathology, or outcomes data in the clinical sense. -
Sample size for the training set:
This information is not provided. If a voice recognition component involves machine learning, there would typically be a training set, but this detail is absent from the summary. -
How the ground truth for the training set was established:
Not provided. This detail would only be relevant if the device incorporated advanced AI/ML for voice recognition requiring specific training data and ground truth labeling, which is not elaborated upon in this 1999 document.
§ 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.