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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™ Electro-surgical 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, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew 400 Insufflator. 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 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 providing voice control for ancillary devices in surgical settings.

Here's an analysis of the acceptance criteria and supporting studies 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 document details various engineering and safety standards (e.g., IEC, EN, UL, CAN/CSA) and internal company tests (CMI System Functional Testing, Software Verification and Validation, Environmental Testing). These types of tests typically involve controlled laboratory environments and specific test configurations, rather than human subject test sets with "data provenance" in the sense of patient data. Therefore, the concept of sample size and data provenance (country of origin, retrospective/prospective) for clinical test sets is not applicable to the data presented in this submission, as it focuses on demonstrating compliance with technical and safety standards.

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

This information is not provided in the document. The tests performed are primarily engineering and hardware/software verification and validation, which rely on defined test procedures and specifications rather than expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the types of engineering and safety tests outlined.

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

An MRMC study was not conducted, as the submission focuses on the safety and effectiveness of a control system for medical devices, not on the interpretation of medical images or data by human readers. The device aims to simplify control during surgery, not to aid in diagnostic or interpretive tasks where an MRMC study would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The submission describes device testing in terms of compliance with various technical and safety standards (e.g., electrical safety, EMC, software functionality). These demonstrate the algorithm's functionality and performance in a standalone capacity within the system's design parameters. However, it's important to note that the device's intended use is inherently with a human operator (the surgeon) in the loop, as it provides "voice control for ancillary devices" and aims to eliminate "relying on verbal communications between the surgeon and other personnel." The described tests verify the technical integrity of the standalone components. While the performance of the voice control algorithm itself would have been tested, the document does not break down specific "standalone algorithm performance" metrics separate from the broader system functional tests (e.g., VA-24772, CP-15345).

7. Type of Ground Truth Used

The ground truth for the various tests appears to be:

• Established industry standards and regulations: For tests like IEC, UL, EN, and CAN/CSA, the ground truth is compliance with the specified requirements and limits defined in those standards.
• System specifications and design documents: For CMI's internal functional, software, and environmental testing (VA-24772, CP-15345, VA-19795), the ground truth would be predetermined performance specifications, design requirements, and expected operational parameters of the HERMES® O.R. Control Center.

8. Sample Size for the Training Set

This information is not provided and is not applicable. The HERMES® O.R. Control Center is a control system that seems to rely on voice recognition and device integration. While a voice recognition component would historically have a training set, the submission does not detail its development or any machine learning training sets. Instead, the focus is on the safety, electrical, and functional performance of the integrated system.

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

This information is not provided and is not applicable.

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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 System, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®R (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, Skytron Stellar Series O.R. Lights, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew InteliJET Arthroscopic Fluid 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, appendectorny, laparoscopic pelvic lymph node laparoscopic 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 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 device that allows for voice control of ancillary medical devices during surgical procedures. The 510(k) summary provides information on the device's adherence to various engineering and safety standards, but it does not include a study proving device performance against specific clinical acceptance criteria in terms of AI accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various standards the device was tested against. These are primarily safety, electrical, and software validation standards, not performance metrics related to diagnostic accuracy or clinical outcomes often seen in AI/ML medical devices. Therefore, the "reported device performance" in relation to clinical acceptance criteria is not applicable or provided in this context.

Note: This submission primarily focuses on electrical safety, electromagnetic compatibility, and software validation for a device that provides voice control functionality. It is not an AI/ML device in the modern sense that interprets data for diagnostic or predictive purposes, and therefore, typical AI acceptance criteria like sensitivity, specificity, or AUC based on clinical data are not present.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" for performance evaluation in the context of diagnostic or predictive AI. The testing mentioned refers to technical standards compliance (functional, environmental, software). Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As there is no clinical "test set" for evaluating diagnostic or predictive performance, there is no information on experts establishing ground truth. The device's function is voice control, and ground truth would relate to the accuracy of voice command recognition and execution, which would be covered under functional testing (VA-24772).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set for diagnostic/predictive performance 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 O.R. Control Center is a voice-controlled interface for surgical equipment, not an AI system designed to assist human "readers" (e.g., radiologists interpreting images). The purpose is to streamline control, not to improve diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a "human-in-the-loop" device by its very nature, as it responds to voice commands from a surgeon. Therefore, a standalone (algorithm only) performance, in the context of interpretation, is not applicable. Its standalone performance would be its ability to accurately recognize and execute commanded actions, which would fall under functional testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the functional aspects of the device, the ground truth would likely be the correct understanding and execution of voice commands by the system, as verified during "CMI System Functional Testing" (VA-24772) and "CMI Software Verification and Validation" (CP-15345). This is not a clinical ground truth like pathology or outcomes data, but rather a technical ground truth related to functional correctness.

8. The sample size for the training set

This device, in this submission, is not described as an AI/ML device that undergoes "training" on a dataset in the modern sense (e.g., for image recognition or predictive analytics). It's a control system with voice recognition. The "training" for such a system typically involves developing and refining the voice recognition algorithms against a collection of voice commands, but the document does not specify a training set size or methodology.

9. How the ground truth for the training set was established

Given the absence of a described "training set" as understood in current AI/ML contexts, there is no information on how ground truth for a training set was established. For voice recognition, ground truth would usually involve correctly transcribed speech paired with the associated intended action, but these details are not provided in the 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™ Electro-surgical Unit. Smith & Nephew Dvonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, Smith & Nephew Dyonics® Power Shaver, and the Smith & Nephew Dyonics® 325Z DV Camera. 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 cholecystectorny, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection. laparoscopically assisted hvsterectomy. 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.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes a 510(k) submission for a modification to the HERMES® O.R. Control Center. The provided text primarily focuses on regulatory compliance with various standards and provides limited detail on specific performance acceptance criteria or detailed study results beyond the fact that testing was conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several international and internal standards to which the device was tested. The "acceptance criteria" for these would typically be compliance with the requirements outlined in each standard. However, the document does not provide specific numerical performance metrics or acceptance thresholds for these tests, nor does it present the reported device performance values against such thresholds. It only states that the device "has been tested to the following standards."

Therefore, the table below reflects the tests performed, but the specific acceptance criteria and performance data are not detailed in the provided text.

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

The document does not provide details on "sample size" in the context of test sets for performance evaluation (e.g., number of procedures, patients, or data points). The listed tests are primarily related to product safety, electrical compatibility, and internal functional/software verification. These types of tests typically involve physical units of the device or software code, rather than patient-derived data sets.

The data provenance is not applicable in the context of these engineering and safety tests.

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

This information is not applicable to the type of tests described. None of the listed tests require a "ground truth" established by medical experts in the way an AI diagnostic device would. The standards relate to safety, electrical, and software compliance.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of cases to establish ground truth for a diagnostic device. This is not relevant to the engineering and safety tests listed in the document.

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

No MRMC study is mentioned or implied by the listed tests. The device is a control center for surgical equipment, primarily offering voice control. The document describes it as "allowing for simplified and more direct control," but does not present a study comparing human reader performance with and without AI assistance for tasks like diagnosis or image interpretation.

6. Standalone Performance Study

The document does not describe a standalone performance study in the typical sense of evaluating an algorithm's performance on a dataset without human intervention. The "System Functional Testing" (VA-24772) and "Software Verification and Validation" (CP-15345) would involve evaluating the device's functions independently, but these are engineering verification tests, not clinical performance studies on patient data.

7. Type of Ground Truth Used

Given the nature of the listed tests (safety, electrical, environmental, software), the concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable. The "ground truth" for these tests would be defined by the specifications of the standards themselves (e.g., a certain level of electrical emission, a functional requirement, or a software behavior).

8. Sample Size for the Training Set

The document describes a modification to an existing device, the HERMES® O.R. Control Center, which primarily offers voice control for ancillary devices. The concept of a "training set" is typically associated with machine learning or AI models that learn from data. While the voice control aspect might involve some form of speech recognition that was "trained," the document does not provide any information regarding training sets, their size, or how they were used.

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

As no training set is mentioned, this information is not provided. If voice recognition was involved, the "ground truth" for training would typically involve annotated audio data where spoken commands are correctly transcribed/labeled.

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The Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS® MicroWrist™ Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.

This premarket notification adds a bipolar grasper and bipolar scissors to the ZEUS® MicroWrist™ Surgical System. These surgical instruments are used in conjunction with an electrosurgical generator unit (ESU), and they augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System. These devices are additions to the MicroAssist 100 line of ZEUS surgical instruments. MicroAssist instruments consist of commercially available hand-held devices that have been modified in order to be attached to the ZEUS arm. As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version. The ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner which provides the surgeon with a steady view of the internal operating field. The HERMES® O.R. Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS System.

The provided document describes a 510(k) summary for Bipolar Grasper and Bipolar Scissors for the ZEUS® MicroWrist™ Surgical System. This submission focuses on establishing substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined performance metrics.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of regulatory submission. The document reports on non-clinical tests to demonstrate substantial equivalence, not a clinical trial with specific performance endpoints.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A) in the context of specific performance metrics.

This 510(k) submission is for substantial equivalence. The "acceptance criteria" are implicitly met by demonstrating that the new devices are "substantially equivalent in terms of size, shape, function, activation, and intended use to the predicate devices cited." The "reported device performance" is that these characteristics are maintained, even when manipulated by the robotic system.

Also: "As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version."

Conclusion: "Data provided in this submission indicate that the basic functional characteristics of these devices are substantially equivalent to the predicates." |

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

Not directly applicable as a clinical "test set" demonstrating performance metrics.

The submission relies on non-clinical tests to establish substantial equivalence. The document does not specify a "sample size" for a test set in the way one would for a clinical performance study (e.g., number of patients or cases). The "data provenance" would be from internal engineering and bench testing, likely conducted by Computer Motion, Inc. There is no mention of country of origin for clinical data.

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

N/A. Ground truth from clinical experts is not relevant here as it's not a clinical performance study. The "ground truth" for substantial equivalence is based on engineering specifications and physical characteristics compared to predicate devices.

4. Adjudication Method for the Test Set

N/A. No adjudication method is described as there isn't a clinical test set requiring expert review or consensus.

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

N/A. This device is a surgical instrument (bipolar grasper and scissors), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.

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

N/A. This device is a surgical instrument that is part of a surgical system controlled by a human surgeon (“ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments”). It is not an algorithm, and the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:

• Engineering specifications and design characteristics of the new devices (Bipolar Grasper and Bipolar Scissors).
• Comparison to the known specifications and performance of the predicate hand-held devices (Lyons™ Dissecting Forceps and Evershears®).
• The fact that "the distal end that is used to perform surgical tasks remains unchanged from the hand-held version" implies that the functional part of the device is identical to established predicate devices.

8. The Sample Size for the Training Set

N/A. As this is a 510(k) for surgical instruments demonstrating substantial equivalence through non-clinical testing, there is no "training set" in the context of machine learning or AI.

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

N/A. See point 8.

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The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.

The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.

The provided document is a 510(k) summary for a medical device called the "SCB Computer Motion Interface Controller" (SCIC). It focuses on establishing substantial equivalence to a predicate device and demonstrating adherence to various electrical and safety standards.

There is no information in the provided document about:

• Acceptance criteria for clinical performance or diagnostic accuracy. The document exclusively discusses electrical safety and functional equivalence.
• A clinical study involving human patients or data to prove device performance in terms of diagnostic or clinical outcomes.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth (pathology, outcomes data).

The "Device Testing" section only mentions "Hazard analyses and hardware/software validations procedures were provided in this submission." This indicates that the testing focused on engineering and functional validation, not clinical performance.

Based on the provided text, the only "acceptance criteria" and "device performance" described are related to compliance with electrical and medical device safety standards.

Here's a summary of what is available regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Study Demonstrating Acceptance Criteria:

The "study" or rather, the evidence provided to demonstrate that the device meets its acceptance criteria, consists of the following:

• Compliance with various international and national electrical and medical device safety standards (IEC, UL, EN, CISPR, CSA). The document explicitly lists these tests that the SCIC was subjected to.
• Hazard analyses and hardware/software validation procedures. These were submitted as part of the 510(k) application.
• Establishment of substantial equivalence to the predicate device (HERMES® Port Expander) in terms of intended use and technological characteristics (providing additional device connection ports). The FDA's letter confirms this determination.

2. Sample size used for the test set and the data provenance

• Not Applicable. This device is an interface controller, not a diagnostic or clinical AI device that processes data from a test set of patient cases. The testing described relates to electrical safety and functional validation of the hardware and software components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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. This is not an AI device involved in diagnostic interpretation or human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm or AI device. It's a hardware interface controller.

7. The type of ground truth used

• Not Applicable. The "ground truth" for this device's validation is adherence to engineering specifications, electrical safety standards, and functional performance as an interface. There is no biological or diagnostic "ground truth" in the context of this submission.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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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, 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

• 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.

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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 ZEUS® MicroWrist "Surgical System (ZEUS System) and Accessories are intended to be used to assist a surgeon during procedures such as Laparoscopic Cholecystectomy and Nissen Fundoplication, to hold and position an endoscope, and to control laparoscopic instruments in performance of the surgical tasks of grasping, sharp cutting, blunt dissection, electro-cautery and suturing with knot placement. The ZEUS System is intended to be used by surgeons who are trained in minimally invasive surgery, have successfully completed a ZEUS System training program, and are certified in accordance with their respective hospital's customary practice for ZEUS System use. The ZEUS® MicroWrist™ Surgical System is intended to be used in an operating room environment in which the ZEUS System, the operating surgeon and patient are in the same room.

The ZEUS® MicroWrist™ Surgical System (ZEUS System) and Accessories, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner, which provides the surgeon with a steady view of the internal operating field. The HERMESTM Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS® MicroWrist™ Surgical System and Accessories, and has been cleared to operate with many ancillary devices.

The provided text is a 510(k) summary for the ZEUS® MicroWrist™ Surgical System and Accessories. While it outlines the device's intended use, safety standards, and mentions clinical trials, it does not contain specific acceptance criteria or detailed results of a study that directly prove the device meets such criteria in a quantitative manner (e.g., sensitivity, specificity, or surgical success rates with defined thresholds).

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The clinical trials are described as comparative effectiveness studies against standard laparoscopic surgery, proving safety and effectiveness for a new indication for use based on overall outcomes rather than pre-defined performance metrics for the device itself.

Therefore, much of the requested information cannot be extracted directly from this document. I will fill in what is available and indicate when information is "Not provided in the text."

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample size: "over 200 patients" across two extensive clinical trials.
   • Data provenance: Not explicitly stated, but the submission is to the US FDA, so the trials would likely have been conducted, at least in part, in the US or under protocols acceptable to the FDA. The trials were "prospective, randomized, concurrently controlled."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not provided in the text. The clinical trials compared the ZEUS system to standard laparoscopic surgery. The "ground truth" here would likely be the patient outcomes and surgical success as determined by the operating surgeons and follow-up, rather than individual expert adjudication of data derived from the device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided in the text. Clinical trials usually involve assessment by the operating team and follow-up clinicians, but a specific adjudication method for study endpoints (like 2+1 review for image-based diagnostics) is not mentioned.

4. 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:

   • This was a comparative effectiveness study, comparing the ZEUS system (a surgical robot assisting the surgeon) to standard laparoscopic surgery. It was not a "multi reader multi case" study in the typical diagnostic AI sense.
   • The study design was "two extensive, prospective, randomized, concurrently controlled clinical trials" comparing the ZEUS system to standard laparoscopic surgery.
   • Effect size of human readers improvement with AI (robot) vs. without AI (robot) assistance: The document states that "surgeons trained in the ZEUS System and minimally invasive surgery experienced a minimum 13-case learning curve to approximate procedure time with control." This indicates that with training on the ZEUS system, surgeons could achieve similar procedure times to standard methods. It doesn't quantify improvement over unaided human performance in a general sense, but rather comparative performance after a learning curve. No specific effect size (e.g., mean procedural time reduction) is given in the summary beyond the learning curve observation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this device is explicitly designed as a surgeon's assistant ("assist a surgeon"), so a standalone algorithm-only performance study would not be relevant or possible given its nature as a surgical manipulation system. The "human-in-the-loop" (the surgeon) is integral to the device's function.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical trials, the ground truth would be patient outcomes and successful completion of surgical procedures (Laparoscopic Cholecystectomy and Nissen Fundoplication) as evaluated by clinical criteria, surgical reports, and post-operative follow-up.

7. The sample size for the training set:

   • Not applicable in the typical sense of machine learning model training data. This device is a surgical system, not an AI diagnostic algorithm trained on a dataset. The "training" mentioned refers to the surgeon's training on how to use the device, not the device's algorithmic training.

8. How the ground truth for the training set was established:

   • Not applicable for the reasons mentioned above.

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