(20 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 and W.O.M. 2.0L Arthroscopy Pump. 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 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 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, W.O.M. 20L Insufflator and W.O.M. 2.0L Arthroscopy Pump 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.
Here's an analysis of the provided text regarding the HERMES OR Control Center, focusing on acceptance criteria and study details.
Based on the provided information, the HERMES OR Control Center is a medical device, and its "acceptance criteria" primarily relate to compliance with established medical device safety and electrical standards, rather than a clinical performance study with specific metrics like sensitivity or specificity for a diagnostic AI device.
This device, described as a "computer-driven system whose basic function is to offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control," appears to be an interface or control system for existing medical equipment. Therefore, its safety and effectiveness are evaluated based on its safe and reliable operation in controlling those devices, not on its ability to interpret medical data or make diagnoses.
Here's a breakdown of the requested information, where applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (based on the provided text) | Reported Device Performance (implied from the 510(k) submission) |
|---|---|
| Safety and Electrical Standards Compliance: | |
| IEC 601-1 Second Edition 1990 | Compliance stated in 510(k) submission ("HERMES OR Control Center is designed and tested to the following Computer Motion and voluntary standards.") - Pass |
| IEC 601-1 Amendment 1 1991 | Compliance stated in 510(k) submission - Pass |
| IEC 601-2-18 First Edition 1990 | Compliance stated in 510(k) submission - Pass |
| UL 2601-1 Conducted & Radiated Emission | Compliance stated in 510(k) submission - Pass |
| EN55022/A1: 1995 Immunity Tests | Compliance stated in 510(k) submission - Pass |
| EN61000-4-2: 1995 | Compliance stated in 510(k) submission - Pass |
| EN61000-4-3: 1995 | Compliance stated in 510(k) submission - Pass |
| EN50140:1994 | Compliance stated in 510(k) submission - Pass |
| EN61000-4-4:1995 | Compliance stated in 510(k) submission - Pass |
| EN61000-4-5:1995 | Compliance stated in 510(k) submission - Pass |
| EN61000-4-6:1995 | Compliance stated in 510(k) submission - Pass |
| CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 | Compliance stated in 510(k) submission - Pass |
| Functional Equivalence: | |
| Substantially equivalent to K990787 | FDA determination of "substantially equivalent" to predicate device K990787 - Accepted (This implies that its functionality and safety profile are comparable to a previously cleared device). |
| Intended Use: | |
| Indicated for use with specific medical devices | The device is indicated for use with the listed Stryker and W.O.M. devices in the specified endoscopic procedures. The 510(k) clearance confirms this intended use. - Accepted |
| Allow simplified and more direct control of device settings by physician (via voice) | This is the core functional benefit described. The 510(k) clearance implies that the voice control mechanism was deemed safe and effective for this purpose, likely through internal validation and adherence to usability standards (though specific usability data is not detailed in this summary). - Accepted |
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not contain details about a "test set" in the context of an AI/ML algorithm evaluation with patient data. The testing discussed is related to compliance with electrical and safety standards. There is no mention of a dataset of patient cases, images, or clinical scenarios used to evaluate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, there is no "test set" of patient data for which a ground truth would need to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No such test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The HERMES OR Control Center is not an AI-assisted diagnostic or interpretative device that would involve human "readers" or an MRMC study. It is a control interface.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is inherently "human-in-the-loop" as its function is to control other medical devices based on surgeon voice commands. It does not perform a standalone diagnostic or therapeutic algorithm in a way that typically refers to "standalone performance" in AI/ML contexts.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth regarding patient data or diagnoses is relevant to the acceptance criteria described. The "ground truth" for this device would be its correct and safe execution of voice commands to control integrated medical equipment, and its compliance with safety standards.
8. The sample size for the training set
Not applicable. The device is not an AI/ML model that would typically have a "training set" of data for learning patterns or making predictions. It's a control system.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
Summary of Device Evaluation Approach:
The 510(k) clearance for the HERMES OR Control Center primarily relied on:
- Conformance to Recognized Standards: The device was designed and tested to numerous international and national electrical, safety, and electromagnetic compatibility standards (IEC, UL, EN, CAN/CSA). This is the primary "acceptance criteria" explicitly listed.
- Substantial Equivalence: The FDA determined the device was substantially equivalent to a previously cleared predicate device (K990787). This means the FDA found no new questions of safety or effectiveness were raised by the HERMES device that were not already addressed by the predicate. This comparison typically involves evaluating similarities in design, materials, indications for use, energy used, technology, and performance.
- Functionality: The device's ability to provide voice control for specific surgical equipment, as described in its intended use, was accepted. (Details on how this specific voice control functionality was validated are not present in this summary but would have been part of the full 510(k) submission, likely including internal testing and verification).
In essence, this is a traditional medical device clearance where safety and performance are demonstrated through adherence to known engineering and electrical standards, and by showing equivalence to an already approved device, rather than through a clinical study involving patient data and AI performance metrics.
§ 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.