(58 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, AESOP®HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Smith & Nephew Dyonics® Vision 635 Digital Image Management System. 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 lymph node dissection, laparoscopically assisted hysterectomy, 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 users of the HERMES O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.
Here's an analysis of the provided text regarding the HERMES™ O.R. Control Center, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness for the HERMES™ O.R. Control Center. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, rather than presenting a detailed clinical study with specific performance metrics and acceptance criteria in the way a novel AI-driven diagnostic device might. Therefore, many of the requested fields, particularly those related to AI-specific study designs (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance), are not applicable or detailed in this document.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance / Evaluation Method |
|---|---|---|
| Safety and Electrical Standards | Compliance with recognized international and national standards for medical electrical equipment, electromagnetic compatibility (EMC), and safety. This implies the device must operate safely without causing electrical hazards, interference, or being susceptible to interference. | The HERMES O.R. Control Center has been tested to and found compliant with numerous standards, including: |
- IEC 601-1, IEC 601-1 Amendment 1, IEC 601-2-18, EN 60601-1, EN 60601-1-1, EN 60601-1-2 (Medical Electrical Equipment Safety)
- UL 2601-1, CAN/CSA-C22.2 No. 601.1 (Underwriters Laboratory / Canadian Electrical Safety)
- EN55022/A1 (Conducted/Radiated Emission), EN61000-4-2 (ESD), EN61000-4-3 & EN50140 (RF Immunity), EN61000-4-4 (EFT/Bursts), EN61000-4-5 (Surge), EN61000-4-6 (Conducted Immunity) (EMC Compliance) |
| Functional Performance | The system's basic function is to offer voice control of ancillary devices and to interface correctly with a specified list of medical equipment. It must perform its intended voice control operations accurately and reliably. | System Functional Testing (VA-23829-002) was conducted. While specific performance metrics (e.g., voice recognition accuracy, response time) are not provided in this summary, the completion of this test implies the device met its functional requirements. The device is also explicitly indicated for use with a list of specific devices. |
| Software Verification and Validation | The software controlling the device must be verified and validated to ensure it functions as intended, is free from critical defects, and performs reliably within the specified operational parameters. | Software Verification and Validation (CP-15345-002) was performed, indicating that the software was rigorously tested to confirm its correctness and reliability. |
| Environmental Performance | The device must withstand specified environmental conditions (e.g., temperature, humidity) encountered during storage, transport, and operation without degradation of performance or safety. | Environmental Testing (VA-19795-002) was performed, confirming the device's resilience to various environmental factors. |
| Substantial Equivalence to Predicate | The device must be demonstrated to be as safe and effective as a legally marketed predicate device, meaning it does not raise new questions of safety or effectiveness. This is a primary acceptance criterion for 510(k) clearance. | The device was determined by the FDA to be "substantially equivalent" to the HERMES O.R. Control Center (K973700) and an updated version for Valleylab Force FX™ (K003222). This implies that through testing and comparison, the device's characteristics and performance are comparable to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device clearance based on engineering and conformity testing to standards, along with a demonstration of substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or treatment performance against a large test set of patient data.
- Test Set Sample Size: Not applicable in the context of patient data. The "test set" here refers to the actual HERMES device and its components undergoing engineering and functional tests.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from the results of the various technical standards tests (e.g., electrical safety measurements, EMC measurements, software tests, functional tests on the device itself).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the sense of expert consensus on patient diagnoses or outcomes, is not relevant for this type of device clearance. The "ground truth" for this device is adherence to engineering specifications and regulatory standards. The experts involved would be engineers, quality assurance personnel, and regulatory specialists conducting the tests and assessments.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication method" in the sense of resolving discrepancies among expert interpretations of patient data. Test results against standards are objective measurements or pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is typically performed for diagnostic imaging devices or AI tools that assist human readers in interpreting clinical data. The HERMES O.R. Control Center is a voice-controlled surgical control system, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, and not applicable. While the device has software components (as evidenced by "Software Verification and Validation"), it's an interactive control system designed to be used by a human surgeon. Its performance is intrinsically linked to human interaction (voice commands) and its ability to control other devices as instructed. It's not an "algorithm only" device in a diagnostic sense.
7. The Type of Ground Truth Used
The "ground truth" for this device clearance is primarily:
- Engineering Specifications and Performance Standards: The device's operational parameters, safety features, and functional capabilities must meet predefined engineering and regulatory requirements.
- Compliance with Recognized Standards: Successful completion of tests against established international and national standards (IEC, UL, CSA, EN).
- Functional Adequacy: The device correctly performs its intended function of voice control and interoperability with listed medical devices.
- Substantial Equivalence: The comparison to legally marketed predicate devices demonstrates that the new device is as safe and effective.
8. The Sample Size for the Training Set
Not applicable. The HERMES O.R. Control Center is not an AI/machine learning device that learns from a "training set" of data in the way a diagnostic algorithm might. Its functionality relies on programmed logic and potentially speech recognition models, but the concept of a "training set" in the context of clinical data for performance validation is not relevant here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" or "ground truth" for it in the context of an AI-driven diagnostic device. If the device uses speech recognition, the "ground truth" for that component would involve annotated voice commands used to train the speech recognition model, but this specific detail is not part of the 510(k) summary.
§ 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.