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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is also indicated for use in nipple sparing mastectomy (NSM) procedures. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is also indicated for use in nipple sparing mastectomy (NSM) procedures. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci SP Surgical System is designed to enable complex surgical procedures using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with an endoscope, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the endoscopic image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscopic image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and endoscope. The Patient Cart is positioned beside the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the endoscope. The bedside surgical assistant installs and removes the endoscope and instruments intra-operatively as needed.

This 510(k) is for a labeling modification only, to add "nipple sparing mastectomy (NSM) procedures" to the indications, and to add "nipple sparing mastectomy" as new representative, specific procedures in the Professional Instructions for Use. There have been no technical changes to the device.

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da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is also indicated for use in cholecystectomy, inguinal hernia repair, and appendectomy procedures. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci SP Instruments:

Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic, surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is also indicated for use in cholecystectomy, inguinal hernia repair, and appendectomy procedures. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with an endoscope, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the endoscopic image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscopic image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and endoscope. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the endoscope. The patient-side assistant installs and removes the endoscope and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "cholecystectomy, inguinal hernia repair, and appendectomy" to the cleared labeling.

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da Vinci SP Surgical System, Model SP1098:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

EndoWrist SP Instruments:
Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci SP Surgical System is a robotically-assisted surgical device that is designed to enable complex surgery using a minimally-invasive approach. The system consists of three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.

At the Surgeon Console, the surgeon controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the live endoscope image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.

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da Vinci SP Surgical System, Model SP1098

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci SP Instruments

Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach, and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci SP Surgical System is a robotically-assisted surgical device that is designed to enable complex surgery using a minimally-invasive approach. The system consists of three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.

At the Surgeon Console, the surgeon controls all movement of the instruments and endoscope by using two hand controls and a set of foot pedals. The surgeon views the live endoscope image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Surgical System, Model IS5000, is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console (Surgeon Console or SSC), a Robot (Patient Side Cart orPSC), and a Tower (Vision Side Cart or VSC) and is used with an endoscope, instruments, and accessories.

The basis for this submission is the initial submission of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include compatibility support of Harmonic ACE™ Curved Shears. Harmonic ACE™ Curved Shears was previously cleared to be used with da Vinci Surgical Systems Model IS4000 under K143132. This modification does not change the Harmonic ACE™ Curved Shears. It changed the da Vinci Surgical System Model IS5000 software to allow Harmonic ACE™ Curved Shears to be used with the IS5000 system. This modification also includes changes to the da Vinci Surgical System, Model IS5000 device labeling for instruments and accessories.

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da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci SP Instruments:

Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci SP Surgical System, Model SP1098, is a software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories.

The provided FDA 510(k) Clearance Letter for the da Vinci SP Surgical System (K251324) does not contain the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

This document is for a robotic surgical system, not an AI/ML software device for diagnostic or analytical purposes. The clearance focuses on hardware, software for controlling the hardware, and human factors related to the physical use of the surgical system.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics for an AI/ML algorithm or corresponding acceptance criteria.
2. Sample sizes used for the test set and the data provenance: No test set, data provenance, or sample sizes related to an AI/ML model are mentioned.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as there's no AI/ML model for which ground truth would be established by experts for performance evaluation.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes human factors evaluation related to the usability of the surgical system, not diagnostic performance with AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no standalone AI algorithm being cleared.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document mentions "Software verification and validation have been conducted at the unit, integration, and system level to confirm that the subject devices continue to meet design requirements and user needs" and "Human Factors Evaluation including usability validation has been conducted to demonstrate safety and effectiveness." These are general statements about software and usability testing for a medical device, but they do not detail the specific performance metrics, acceptance criteria, or study designs typically used for AI/ML devices as requested in the prompt.

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The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.

The da Vinci SP Firefly Imaging System consists of a near-infrared laser light source located in the Endoscope Controller and a connected endoscope. The Firefly imaging system uses near-infrared light in conjunction with the imaging agent Indocyanine Green (ICG), to create fluorescent images of tissue. ICG is administered to the patient according to its manufacturer's labeling, and the system is switched to Firefly imaging. Two modes are available in Firefly imaging: Standard mode and Sensitive mode. When Firefly is active in Standard mode, the system displays the resulting images as a fluorescent (green) overlay on a gray-scale background image. In Sensitive mode, the gray-scale background is no longer illuminated, resulting in increased sensitivity to fluorescent signal.

This FDA 510(k) clearance letter pertains to the da Vinci SP Firefly Imaging System, focusing on a new "Sensitive Firefly" imaging mode.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the device's performance, nor does it provide a table of reported device performance metrics against such criteria. It generally states that "Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness, analogous to the results of the predicate device verification and validation testing." This implies that the new mode performs comparably to the predicate device, but specific metrics are not detailed.

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

The document states "clinical validation testing with an animal model" was performed.

• Sample Size: Not specified.
• Data Provenance: Animal model; implies prospective (testing performed specifically for this submission). The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not specified in the document.

4. Adjudication Method for the Test Set

Not specified in the document.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement for human readers with AI assistance. The device description is for an imaging system, not an AI-assisted diagnostic tool in the typical sense that would involve human reader performance comparisons.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The device is an imaging system designed for surgeons to visualize tissues in real-time. It's not an "algorithm only" device in a standalone diagnostic capacity. The testing described (bench and animal model) supports its functionality as an imaging tool to be used by a surgeon.

7. Type of Ground Truth Used

The document mentions "clinical validation testing with an animal model" to confirm "no issues of safety or effectiveness." This suggests the ground truth was likely based on observed physiological responses in the animal model, evaluating whether the system accurately visualized vessels, blood flow, and tissue perfusion using ICG, as intended. However, the specific method for establishing this ground truth (e.g., direct observation, histopathology) is not detailed.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. Given the description, the device appears to be an imaging hardware system with a new mode, rather than a machine learning model that would typically have a distinct training phase with a labeled dataset. The verification and validation testing focus on confirming the functionality of the imaging system itself.

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

As no training set is mentioned for an algorithm, the method for establishing its ground truth is not applicable or described in this document.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Surgical System Model IS5000 (also referred to as dV5) is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

This submission is based on the software and labeling modification to the da Vinci Surgical System, Model IS5000, previously cleared under K232610. The IS5000 system software has been modified to enable features including Focused Mode, 3D Model Viewer, and Video Review. The Device Labeling of the da Vinci Surgical System, Model IS5000, is also modified to reflect the additional features.

Focused Mode is a new menu mode within the da Vinci Surgical System IS5000 Graphical User Interface (GUI) that allows users to access and interact with 3D Model Viewer and Video Review.

3D Model Viewer (3DMV) is a software feature that enables the da Vinci Surgical System IS5000 system to display and manipulate 3D Models and 2D image files directly on the da Vinci Surgeon Console graphical user interface.

Video Review is a software feature that allows the surgeon to record surgical case video on the da Vinci Surgical System IS5000, create bookmarks, and review the video and bookmarks intraoperatively.

The provided FDA 510(k) clearance letter for the da Vinci Surgical System, IS5000 (K250442) describes modifications to an existing device, focusing on software and labeling updates for new features: Focused Mode, 3D Model Viewer, and Video Review. As such, the study described is primarily focused on demonstrating that these new features do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

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

The document does not explicitly present a "table of acceptance criteria" with specific quantitative thresholds. Instead, it states that "All testing performed met its predetermined acceptance criteria and supports the subject device changes." The acceptance criteria are broadly described by the types of testing conducted and the regulatory guidance followed. The reported device performance is that these tests were met.

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

The document does not specify a sample size for any of the testing conducted. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily focused on internal verification and validation of the software and human-device interaction rather than a clinical study involving patients or patient data.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth associated with the test set. For "Human Factors Information," it mentions that "human factors validation testing was performed for impacted critical tasks," which would typically involve user testing with representative users (e.g., surgeons). However, details about the number or qualifications of these users/experts are not provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the testing described (software V&V, human factors, cybersecurity), a formal adjudication process akin to clinical trial endpoint determination is generally not applicable or described in this type of submission summary.

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

An MRMC comparative effectiveness study was not conducted. The submission focuses on modifications to an existing surgical system and primarily addresses safety and effectiveness through software, human factors, and cybersecurity testing, rather than comparative clinical outcomes with human readers or AI assistance. The new features (Focused Mode, 3D Model Viewer, Video Review) are enhancements to the user interface and functionality, not diagnostic aids or AI-driven decision support tools that would typically warrant an MRMC study.

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

A standalone performance study of an algorithm without human-in-the-loop performance was not conducted or described. The da Vinci Surgical System is, by definition, a human-in-the-loop system controlled by a surgeon. The new features described are intended to assist the surgeon (e.g., displaying 3D models, reviewing video) rather than operate autonomously.

7. Type of Ground Truth Used

The type of "ground truth" used is not explicitly specified in terms of clinical outcomes, pathology, or expert consensus on a test set. Instead, the "ground truth" for the testing performed likely refers to:

• Design Requirements: For software V&V, the "ground truth" is that the software performs according to its specified requirements and user needs.
• Usability Objectives: For human factors testing, the "ground truth" is that critical tasks can be performed safely and effectively by intended users without unacceptable use errors.
• Security Standards: For cybersecurity testing, the "ground truth" is adherence to established cybersecurity best practices and the mitigation of identified vulnerabilities.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. As the modifications described are for software features (Focused Mode, 3D Model Viewer, Video Review) that enhance the control system but do not appear to involve machine learning models that require a "training set" in the traditional sense, this information is not applicable or provided.

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

As there is no mention of a training set in the document, information on how its ground truth was established is not provided. The system enhancements are described as software functionalities rather than machine learning algorithms that would typically rely on labeled training data and an associated ground truth establishment process.

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