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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, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FXTM Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, and Smith & Nephew Dyonics® Power Shaver. 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 to offer the surgeon the additional option of voice control for ancillary devices.

The intent of the HERMES O.R. 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 ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.

The HERMES® O.R. Control Center is a computer-driven system designed to offer surgeons voice control for ancillary devices in the operating room. This system aims to simplify the control of medical device settings, eliminating the need for manual interfaces on various ancillary devices or verbal communication between the surgeon and other personnel.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided 510(k) summary does not contain information regarding:

• The sample size used for any specific test set.
• The data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The 510(k) summary does not contain information about:

• The number of experts used to establish ground truth.
• The qualifications of those experts.

The tests conducted are primarily engineering and compliance-based (electrical safety, EMC, software verification, environmental testing), rather than clinical performance evaluations that would typically involve expert-established ground truth. The focus is on the device's adherence to recognized standards for safety and fundamental operation.

4. Adjudication Method for the Test Set:

Given the nature of the tests (compliance with IEC, UL, CSA, EN standards, functional testing), an adjudication method in the context of expert review for a "test set" (as might be seen in diagnostic AI) is not applicable or detailed in this summary. The tests involve quantifiable measurements against established standards, and functional checks against specification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

Based on the provided text, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The device is an O.R. control system, not a diagnostic imaging AI that would typically undergo such a study. The "AI" component is its voice control for ancillary devices, which is assessed for functionality and safety rather than diagnostic accuracy or comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

The "HERMES® O.R. Control Center" is itself a standalone system (it functions independently as a computer-driven control center). The provided tests are evaluating the performance of this system as a whole, including its software, electronics, and voice recognition capabilities. There isn't a clear distinction made between "algorithm only" performance versus "human-in-the-loop," as the device's primary function is to serve the human surgeon. Its performance is its standalone capability to interpret voice commands and control ancillary devices.

7. The Type of Ground Truth Used:

For the compliance tests (IEC, UL, CSA, EN standards), the "ground truth" is the published requirements and limits defined by those international and national standards. For CMI System Functional Testing, Software Verification and Validation, and Environmental Testing, the "ground truth" would be the detailed specifications and design requirements internally defined by Computer Motion, Inc. for the HERMES system.

8. The Sample Size for the Training Set:

The 510(k) summary does not contain information regarding a "training set" or its sample size. This type of information is typically relevant for machine learning or AI models that learn from data, which is not explicitly discussed here in that context. While the voice recognition component undoubtedly involves some form of training, details are not provided.

9. How the Ground Truth for the Training Set Was Established:

As no specific training set is discussed, the summary does not provide information on how its ground truth might have been established. For any voice recognition components, ground truth during development would likely involve carefully curated voice commands and their corresponding intended actions, possibly recorded by various speakers in different conditions, and transcribed/labeled for training purposes. However, these specifics are beyond the scope of the provided 510(k) summary.

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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, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, and Skytron Stellar Series O.R. Lights. 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 hysterectorny, 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 to offer the surgeon the additional option of voice control for ancillary devices. The intent of the HERMES O.R. 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 ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.

The HERMES® O.R. Control Center is a computer-driven system designed to provide surgeons with voice control over ancillary medical devices, thereby simplifying device adjustments and reducing reliance on manual interfaces or verbal communication with other operating room personnel.

Here's an overview of its acceptance criteria and the studies performed:

1. Acceptance Criteria and Reported Device Performance:

The provided document lists several international and internal standards the device was tested against. It doesn't explicitly state quantitative performance metrics or acceptance thresholds for these in a comparative table format. Instead, it indicates compliance with these standards.

2. Sample Size for Test Set and Data Provenance:

The document does not specify a sample size for a "test set" in the context of clinical performance or diagnostic accuracy. The tests listed are primarily engineering and compliance standards (e.g., electrical safety, EMC, software verification), which typically involve testing the device itself against predefined specifications rather than a set of patient data.

3. Number of Experts for Ground Truth and Qualifications:

This information is not applicable and not provided in the document as the device is a control system, not a diagnostic or AI-driven system requiring expert-established ground truth for image or data interpretation.

4. Adjudication Method for Test Set:

This information is not applicable and not provided as the device is a control system, not a diagnostic or AI-driven system requiring adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted and is not applicable for this device. The HERMES® O.R. Control Center is a device control system, not an AI-assisted diagnostic tool that would improve human reader performance. Its purpose is to simplify control of other surgical devices, not to aid in diagnosis or interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-loop):

The concept of "standalone performance" as it pertains to an algorithm interpreting data does not directly apply here. The HERMES system's core function is voice control, which is inherently a human-in-the-loop interaction. However, the "CMI System Functional Testing" (VA-23763) and "CMI Software Verification and Validation" (CP-15345) would assess the device's internal algorithms and functionalities independently of a surgeon's specific use case, ensuring it accurately recognizes commands and sends correct signals. The document does not provide specific metrics from these tests.

7. Type of Ground Truth Used:

The "ground truth" for this device would be tied to its functional performance and compliance with engineering standards:

• Compliance with International Standards: The device's operation was measured against the established parameters and requirements of standards like IEC 601-1 for electrical safety, and EN series for EMC.
• Design Specifications: For internal functional testing and software validation, the "ground truth" would be the predefined design specifications and expected behavior of the system, such as accurately interpreting voice commands and correctly controlling integrated medical devices.

The document does not refer to clinical outcomes, pathology, or expert consensus in the same way a diagnostic AI might.

8. Sample Size for Training Set:

This information is not provided and is not directly applicable in the context of traditional machine learning training sets. While the voice recognition component would have been developed using a dataset, this document focuses on regulatory compliance and does not detail the development process of the voice recognition module.

9. How Ground Truth for Training Set was Established:

This information is not provided. If voice recognition software was indeed a core component that required training, the ground truth for that training data would typically involve annotated audio samples where specific voice commands are correctly labeled with their intended actions. However, the document provided does not delve into the specifics of the voice recognition training.

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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:

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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The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump and Berchtold Surgical Lights. 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 & 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 HERMES OR 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, W.O.M. 2.0L Arthroscopy Pump and Berchtold Surgical Lights 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 text describes a 510(k) premarket notification for the HERMES™ OR Control Center, a computer-driven system designed to allow surgeons to control medical device settings using voice commands.

However, the document does not contain information related to acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications, etc.) as requested in the prompt. The text focuses on regulatory classification, indications for use, and substantial equivalence to a predicate device, along with adherence to various electrical and safety standards.

Therefore, I cannot fulfill the request to discuss the acceptance criteria and the study proving the device meets them based on the provided input.

The document lists various standards the device is designed and tested to, such as IEC 601-1, UL 2601-1, and EN standards for emissions and immunity. These are safety and electrical performance standards, not typically acceptance criteria for clinical efficacy or diagnostic accuracy.

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