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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, 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

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.

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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

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.

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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 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:

1. 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.

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):

2. 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.
3. 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.
4. Adjudication method: Not mentioned.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.

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The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is 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 cheleeystectomy, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, 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 intended use of the HERMES OR Control Center is a Voice Control system whose function is to allow for simplified and direct control of Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings by the surgeon, thereby eliminating the necessity of using multiple input interfaces now common in the operating room, or relying upon verbal communications between the surgeon and other personnel in the OR in order to adjust Stryker Endoscopy 882 Camera and Quantum 5000 Light Source.

The provided text is a 510(k) Premarket Notification for the HERMES OR Control Center System. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on a clinical study with detailed performance metrics and acceptance criteria in the way a research paper would.

Therefore, the document does not contain information about:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone (algorithm only) performance
7. Type of ground truth used (e.g., pathology, outcomes data)
8. Sample size for the training set
9. How ground truth for the training set was established

Instead, the document focuses on:

• Device identification and intended use: The HERMES OR Control Center is a computer-driven system offering voice control for Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings. It's intended to simplify control and eliminate the need for multiple input interfaces or verbal communication to adjust settings during various endoscopic procedures like laparoscopy, thoracoscopy, and sinuscopy.
• Substantial equivalence: The device is claimed to be substantially equivalent to AESOP 510(k)'s K931783 and K960655, Model 882 Camera: K820624, and Quantum 5000 Light Source: K961971. This is the primary method of demonstrating safety and effectiveness for a 510(k) submission.
• Compliance with standards: The HERMES OR Control Center was designed and tested to several international and national standards for medical electrical equipment, including IEC 601-1, UL 2601-1, EMC Directive European Union 89/336/EEC, and CAN/CSA-C22.2. It also mentions "HERMES System Functional Test Requirements," but does not detail these requirements or results.
• Regulatory clearance: The FDA reviewed the 510(k) notification and determined the device to be substantially equivalent for the stated indications for use, thereby permitting it to be marketed.

In summary, this regulatory document for the HERMES OR Control Center does not provide the kind of detailed performance study information with explicit acceptance criteria, ground truth, and reader studies that would be found in a clinical trial report or a scientific publication. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices and compliance with relevant safety standards.

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