Search Results
Found 186 results
510(k) Data Aggregation
(148 days)
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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(85 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint Software, a System Cart with System Software, a Controller, Instruments, and Accessories.
The IF1000 Instruments include the Ion Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.
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(89 days)
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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(140 days)
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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(25 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis. The system is indicated for use with adult and pediatric populations. Pediatric use is limited to patients who are 5 ft (152.5 cm) or taller and weigh 102 lbs (46 kg) or greater.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint™ Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion™ Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The IF1000 System and PlanPoint Software are modified to enable Remote Software Updates from the Intuitive server via secure network communication.
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(122 days)
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:
- 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.
- 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.
- 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.
- Adjudication method for the test set: Not applicable.
- 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.
- Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no standalone AI algorithm being cleared.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- 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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(30 days)
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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(165 days)
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.
| Acceptance Criteria Category (Implied from document) | Reported Device Performance (Implied from document) |
|---|---|
| Software Verification and Validation | Met design requirements and user needs at unit, integration, and system levels. Complied with FDA Guidance "Content of Premarket Submissions for Device Software Functions." |
| Human Factors Information | Addressed per recommendations for HF Submission Category 3 in FDA Draft Guidance "Content of Human Factors Information in Medical Device Marketing Submissions." Human factors validation testing was performed for impacted critical tasks. |
| Cybersecurity Testing | Demonstrated adequacy of implemented cybersecurity controls. Complied with FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." |
| Substantial Equivalence | Device is substantially equivalent to the predicate device based on indications for use, device characteristics, and technological characteristics. The new features do not raise new questions of safety or effectiveness. |
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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(96 days)
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 (da Vinci 5) is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console, Robot, and Tower and is used with an endoscope, instruments, and accessories.
The basis for this submission is a modification to the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software has been modified to include a new "force gauge" graphical user interface element, which provides a visual representation of forces applied while completing tasks with the da Vinci Force Feedback instruments.¹ The modification also includes changes to the device labeling.
The provided FDA 510(k) clearance letter and summary for the Da Vinci Surgical System (IS5000) focuses on a software modification, specifically the addition of a "force gauge" graphical user interface (GUI) element. The document does not provide detailed information about clinical performance studies with acceptance criteria in the sense of diagnostic accuracy or clinical outcomes directly tied to the new GUI feature.
Instead, the performance data presented is related to software verification and validation and human factors. This is typical for device modifications where the core functionality of the device remains unchanged, and the modification primarily affects the user interface or internal software operations.
Here's a breakdown of the requested information based only on the provided text, recognizing the limitations of this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since the primary modification is a software change and the addition of a GUI element, the acceptance criteria are not clinical performance metrics but relate to the software's adherence to design specifications and usability.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Software Verification & Validation | All testing passed; continues to meet design specifications and user needs. Software documentation provided according to FDA guidance. |
| Human Factors Validation | Based on Comparative Task Analysis (CTA) and Use-Related Risk Analysis (URRA), human factors validation conducted for impacted critical tasks. All testing passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Software Verification & Validation: The document states "unit, subsystem integration, and system level" testing. This typically involves internal testing by engineers. It does not specify a "sample size" in terms of patient data or clinical cases. The provenance is internal development and testing.
- Human Factors Validation: While a "human factors validation" was conducted, the document does not specify the number of users (the "test set" in this context) involved in these studies. The provenance would be from internal usability testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this software modification submission. The "ground truth" for software verification is adherence to design specifications and functional requirements. For human factors, it relates to usability and safety of interaction, which is assessed through user testing and expert review of the interface. The document does not specify the number or qualifications of "experts" involved in establishing this ground truth.
4. Adjudication Method for the Test Set
Not applicable for the types of testing described. Adjudication methods like "2+1" typically apply to diagnostic studies where multiple readers interpret cases and a consensus or tie-breaker is needed to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or implied to be done for this submission. The submission focuses on verification of the software change and human factors, not on comparing clinical effectiveness with and without the AI assistance (which the force gauge isn't explicitly defined as, but rather a new GUI element for an existing force feedback instrument).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The force gauge is a graphical user interface element that provides visual feedback to the human operator using the Da Vinci Surgical System. It inherently functions "with human-in-the-loop."
7. The Type of Ground Truth Used
- Software Verification & Validation: The "ground truth" is the design specifications and functional requirements of the software. The tests verify that the software performs as designed.
- Human Factors Validation: The "ground truth" is adherence to usability principles and mitigation of use-related risks, assessed through task analysis and user studies against established human factors engineering principles.
8. The Sample Size for the Training Set
Not applicable. This submission concerns a modification to an existing surgical system's software GUI. It does not describe an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "force gauge" is a visual representation of existing force feedback data, not a new predictive or analytical algorithm trained on data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a "training set" for an AI/ML model.
Summary of Device and Study Context:
The Da Vinci Surgical System (IS5000) submission (K251213) is a Traditional 510(k) for a software modification to an already cleared device (K232610). The modification adds a "force gauge" graphical user interface (GUI) element that visually represents forces applied by existing Da Vinci Force Feedback instruments.
The study described is not a clinical effectiveness trial but rather a set of engineering verification and validation activities to ensure the software modification is safe and functions as intended, and that the new GUI element does not introduce new use-related risks. The FDA's clearance is based on the determination that the modified device is substantially equivalent to its predicate device, and the performance data provided (software V&V, human factors) supports this equivalence for the specific modification.
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(89 days)
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.
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 or PSC), and a Tower (Vision Side Cart or VSC) and is used with an endoscope, instruments, and accessories.
The basis for this submission is the modification of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include a new feature called "Networked Central Configuration Management" which enables Intuitive technical support to remotely push configuration data to a system connected to the network for user to update the system. The configuration data includes customer site preference settings and system feature enabling or disabling. The modification also includes changes to the device labeling.
The provided FDA 510(k) clearance letter for the da Vinci Surgical System (IS5000), K251202, describes a submission for a modification to an already cleared medical device, not a completely novel device. The core of this submission revolves around software changes, specifically the addition of a "Networked Central Configuration Management" feature and associated cybersecurity updates.
As such, the detailed information typically found for a new device's performance study (MRMC, expert ground truth, extensive sample sizes for training/test sets, etc.) is not present in this type of 510(k) submission. The FDA clearance is based on demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the new features function as intended without introducing new risks.
Therefore, the response below will focus on what can be inferred or reasonably assumed from the provided document regarding performance criteria and how the device meets them in the context of this specific modification.
Acceptance Criteria and Device Performance for da Vinci Surgical System (IS5000) K251202
Given that this 510(k) submission (K251202) is for a modification to an already cleared device (K232610), the performance data provided focuses on verifying the safety and functionality of the changes rather than re-establishing the fundamental efficacy of the surgical system itself. The core acceptance criteria revolve around ensuring that the new software feature ("Networked Central Configuration Management") and associated cybersecurity updates do not introduce new risks or degrade the existing performance of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from Submission Type) | Reported Device Performance (as per 510(k) Summary) |
|---|---|---|
| Software Functionality | The "Networked Central Configuration Management" feature enables remote pushing of configuration data and updates settings as intended. | Software verification and validation conducted at unit, integration, and system levels confirmed the subject device continues to meet design requirements and user needs. |
| Software Safety | The software changes do not introduce new hazards or adverse events related to device operation. | Software verification and validation confirmed the device continues to meet design requirements and user needs. (Implying safety) |
| Cybersecurity | The device is resilient against identified cybersecurity threats; risk controls are adequate. | Cybersecurity verification and validation conducted confirmed risk control measures based upon the cybersecurity threat model are adequate. |
| Unchanged Performance | The fundamental surgical capabilities (accurate control of instruments, tissue manipulation, etc.) remain unaffected. | "The principles of operation are unchanged." The submission implies no degradation of the original device's performance due to the software modifications. |
| Labeling Accuracy | Device labeling accurately reflects the modified features and any associated warnings/contraindications. | "The modification also includes changes to the device labeling." (Implies accuracy and completeness have been addressed). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative "sample size" in terms of patient cases or surgical procedures for the performance testing of these software modifications. This is typical for software-only changes. Instead, testing would involve a comprehensive set of software validation tests, unit tests, integration tests, and system-level tests for the new functionalities and cybersecurity.
- Data Provenance: Not specified in terms of country of origin. The testing would have been performed by the manufacturer (Intuitive Surgical, Inc.) in a controlled development and testing environment. The data is retrospective in the sense that it's derived from internal validation activities, not a prospective clinical trial for these specific changes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. For software and cybersecurity validation, "experts" would likely be:
- Software engineers and quality assurance (QA) testers experienced in medical device software.
- Cybersecurity experts (e.g., ethical hackers, penetration testers, network security specialists).
- Clinical subject matter experts (e.g., surgeons, clinical engineers) might be involved in reviewing use cases and validating clinical workflows impacted by the new features, but this is not detailed.
- Qualifications of Experts: Not specified. It's assumed they would possess relevant engineering, software development, cybersecurity, and potentially clinical experience for their respective roles in the verification and validation process.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or specified. For software and cybersecurity testing, "adjudication" typically refers to the process of resolving discrepancies in expert interpretations of data (e.g., image reads). In software testing, the "ground truth" is adherence to design specifications and user requirements, as well as absence of bugs and security vulnerabilities. Test results are compared against expected outcomes, not expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC study was not performed. MRMC studies are typically conducted to evaluate the impact of a new diagnostic imaging AI algorithm on human reader performance (e.g., radiologists improving detection rates). This 510(k) is for a surgical system's software modification, not a diagnostic AI.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Standalone Performance Study: Not in the traditional sense of an AI algorithm's diagnostic performance (e.g., sensitivity/specificity for a disease). However, the "Software Testing" and "Cybersecurity Testing" sections represent the standalone performance evaluation of the new software feature and its security aspects in isolation from the full clinical context. This involves testing the software's ability to correctly manage configurations, push updates, and maintain data integrity and security, independent of a specific surgical procedure.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this type of submission, the ground truth is established by:
- Design Specifications and User Requirements: The software is tested against whether it correctly implements the defined functionalities (e.g., "Networked Central Configuration Management" remotely pushes data, updates settings as specified).
- Cybersecurity Threat Models: The security measures are validated against identified threats and vulnerabilities to ensure they provide adequate protection.
- Existing Validated Performance: The ground truth for the core surgical system's performance is assumed from its prior clearance (K232610), and the current testing aims to ensure this performance is not degraded.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The "Networked Central Configuration Management" feature is a conventional software function, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning model in this submission.
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