(133 days)
The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver and WOM 20L Insufflator. It can be used in where nasopharyngoscopy, ear endoscopy, and sinuscopy a laparoscopy, general laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic repair, laparoscopic cholecystectomy, laparoscopic hernia laparoscopic surgeries are ymph node dissection, laparoscopically assisted laparoscopic pelvic appendectomy, hysterectomy, 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 Operating Room Control Center is a robotic 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 and WOM 20L Insufflator 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 document is a 510(k) summary for the HERMES OR Control Center System. This document focuses on the regulatory aspects and the intended use of the device, rather than detailed performance study results with specific acceptance criteria.
Based on the information available, a table of acceptance criteria and reported device performance cannot be fully constructed in the manner requested, as the document does not contain clear, measurable acceptance criteria or detailed study results beyond a statement of functional test requirements.
However, I can extract and infer some information related to the device's testing and regulatory approval based on the text:
Missing Information:
Many of the requested data points (sample size for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth used) are not available in this 510(k) summary document. This document is a regulatory submission summary and typically does not include the detailed raw data or study methodologies to that extent.
Available/Inferred Information from the Document:
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Acceptance Criteria and Reported Device Performance:
The document mentions "HERMES System Functional Test Requirements" as a standard the device was designed and tested to. However, the specific criteria within those requirements and the numerical performance results are not detailed in this summary. The only "performance" discussed is the intended function of the device: to offer voice control for medical device settings, simplifying control and eliminating the need for verbal communication with other personnel or direct interaction with individual device interfaces.
| Acceptance Criteria (Inferred from functionality description) | Reported Device Performance (Inferred/Stated Intent) |
|---|---|
| Functional Control: Ability to offer additional option for surgeon selection of attachment device parameter settings utilizing voice control. | The device's basic function is to offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control. (Implies successful implementation of this core functionality, though no quantitative metrics are given). |
| Simplification of Control: Elimination of the necessity of using various interfaces on connected devices (Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator). | The intent is to allow for simplified and more direct control, thereby eliminating the necessity of using the various interfaces existing on the [listed] devices. (This is a statement of intent and assumed outcome, not a quantified performance metric from a study). |
| Reduction of Verbal Communication: Elimination of reliance upon verbal communications between surgeon and other personnel for adjusting surgical equipment. | The intent is to eliminate relying upon verbal communications between the surgeon and other personnel in the operating room in order to adjust surgical equipment. (Again, an intended outcome, not a measured performance metric from a study detailed here). |
| Compliance with Standards: Adherence to relevant electrical, medical electrical equipment, and EMC standards (IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, UL 2601-1, EMC Directive 89/336/EEC, CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92). This implies passing tests related to safety, electrical compatibility, and performance per those standards. | The device is designed and tested to the following Computer Motion and voluntary standards. (This implies successful compliance, but no specific test results or failure rates are provided. This is a regulatory requirement for safety and basic functionality, not directly a performance metric related to the primary clinical benefit of voice control accuracy or efficiency). "HERMES System Functional Test Requirements" were also cited, but specifics are not given. |
The Study that Proves the Device Meets Acceptance Criteria:
The document broadly states that the device "is designed and tested to the following Computer Motion and voluntary standards," and lists several standards (IEC 601-1, UL 2601-1, EMC Directive, etc.) in addition to "HERMES System Functional Test Requirements."
- The term "study" in the context of clinical performance demonstrating quantitative improvements (e.g., accuracy, efficiency) is not explicitly detailed with methodologies or results in this summary.
- The primary evidence of "safety and effectiveness" for this 510(k) submission appears to be based on substantial equivalence to an existing predicate device (HERMES Operating Room Control Center and Accessories K973700). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This often relies on meeting recognized consensus standards for safety and performance, and demonstrating that the new device functions similarly to the predicate.
Given this context, the document doesn't describe a specific, detailed study with quantitative performance results against explicit acceptance criteria in the way one might expect for a novel diagnostic algorithm. Instead, it attests to design and testing according to established engineering and regulatory standards, and relies on the concept of substantial equivalence.
Specific Requested Information (and why it's mostly unavailable from this document):
- Sample size used for the test set and the data provenance: Not mentioned. This would typically be found in detailed verification and validation reports, not a 510(k) summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Such details are usually part of a clinical validation study.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging AI. For a control system, "effectiveness" might be measured in terms of time savings, error reduction, or surgeon satisfaction, but such a study is not described.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not directly applicable or mentioned. This device is a human-in-the-loop system (voice control by a surgeon). Any standalone performance would be about the voice recognition accuracy and system response, which isn't detailed.
- The type of ground truth used: Not explicitly stated for performance testing. For a control system, ground truth might relate to whether commands were accurately interpreted and executed, or whether the system successfully integrated with and controlled the indicated medical devices. This would be part of functional testing.
- The sample size for the training set: Not mentioned. AI/ML models usually require training sets; while this device uses voice control, it's not described as a deep learning AI in the modern sense. It's more of a robotic control system with voice interface.
- How the ground truth for the training set was established: Not mentioned.
In summary, this 510(k) notification focuses on the regulatory requirements for showing substantial equivalence and compliance with engineering standards for a medical device. It does not provide the kind of detailed clinical or algorithm performance study description (with specific acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be associated with modern AI/ML device submissions, especially those involving image analysis or diagnostic applications. The "study" here is primarily composed of general design and testing to established standards to ensure safety and functional requirements, leading to a determination of substantial equivalence.
§ 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.