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510(k) Data Aggregation
(38 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, W.O.M. 20L Insufflator, W.O.M. 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 Dyonics® Access 15 Arthroscopic Fluid Irrigation 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 HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.
The HERMES™ O.R. Control Center is a computer-driven system for voice control of ancillary devices during endoscopic surgeries.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|---|
| IEC 601-1 / EN60601-1 | International Standard for Medical Electrical Equipment | Device tested to and meets this standard. |
| IEC 601-1 Amendment 1 | International Standard for Medical Electrical Equipment | Device tested to and meets this standard. |
| IEC 601-2-18 | International Standard for Medical Electrical Equipment | Device tested to and meets this standard. |
| UL 2601-1 | Underwriters Laboratory Standard | Device tested to and meets this standard. |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1 | Device tested to and meets this standard. |
| EN55022/A1 Conducted Emission | Conducted Emission Standard | Device tested to and meets this standard. |
| EN55022/A1 Radiated Emission | Radiated Emission Standard | Device tested to and meets this standard. |
| EN61000-4-2 Electrostatic Discharge | Electrostatic Discharge Standard | Device tested to and meets this standard. |
| EN61000-4-3 and EN50140 RF Immunity | RF Immunity Standard | Device tested to and meets this standard. |
| EN61000-4-4 EFT/Bursts Immunity | EFT/Bursts Immunity Standard | Device tested to and meets this standard. |
| EN61000-4-5 Surge Immunity | Surge Immunity Standard | Device tested to and meets this standard. |
| EN61000-4-6 Conducted Immunity | Conducted Immunity Standard | Device tested to and meets this standard. |
| EN60601-1-1 | General Requirements for Safety - Collateral Standard | Device tested to and meets this standard. |
| EN 60601-1-2 Emissions and Immunity Test | Emissions and Immunity Test Measurements Standard | Device tested to and meets this standard. |
| System Functional Testing | N/A (Implied successful operation for intended use) | Successful completion of system functional testing reported. |
| Software Verification and Validation | N/A (Implied successful verification and validation) | Successful completion of software verification and validation reported. |
| Environmental Testing | N/A (Implied successful performance under specified environmental conditions) | Successful completion of environmental testing reported. |
Summary of the Study Proving Device Meets Acceptance Criteria:
The provided document describes a 510(k) submission for the HERMES™ O.R. Control Center, indicating that the device has undergone various tests to demonstrate its safety and effectiveness. The main study described is the testing of the device against a comprehensive set of international and national medical device standards, as listed in the table above. These standards cover aspects such as electrical safety, electromagnetic compatibility, and general safety requirements for medical electrical equipment.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data or images. The testing described is primarily engineering and performance-based to ensure compliance with relevant safety and performance standards. Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not directly applicable to the type of testing reported for this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The "ground truth" for this device's acceptance is its adherence to established engineering and safety standards, rather than a clinical diagnosis or interpretation requiring expert consensus.
4. Adjudication Method for the Test Set:
This information is not applicable as the testing involves compliance with technical standards, not interpretation of clinical data.
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:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The HERMES™ O.R. Control Center is a voice-controlled system for ancillary devices, not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
A "standalone" performance study in the context of an algorithm's diagnostic accuracy was not done. The device's function is to provide voice control, and its performance is evaluated based on its ability to control the integrated devices and its compliance with safety and performance standards, not as a standalone diagnostic algorithm.
7. The type of ground truth used:
The "ground truth" used for this device's acceptance is its compliance with internationally recognized and national medical electrical equipment and safety standards. This is a functional and safety ground truth, rather than a clinical ground truth like pathology, expert consensus on images, or outcomes data.
8. The sample size for the training set:
The document does not mention a "training set." The HERMES™ O.R. Control Center is a control system, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established:
This information is not applicable as there is no mention of a training set or machine learning components in the described device.
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