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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 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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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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IRISeg is intended for use as a software application that receives DICOM compliant contrastenhanced CT images, provides manual and machine learning-enabled tools for image analysis and segmentation, and creates an output file that can be used to render a 3D model for preoperative surgical planning and intraoperative display. The use of IRISeq may include the generation of preliminary segmentations using machine learning algorithms. IRISeg is intended for use by qualified professionals. The output file is meant for visual, non-diagnostic use and shall be reviewed by clinicians who are responsible for all final patient management decisions.

The machine learning enabled kidney CT auto-seamentation tool is intended for use for adult patients with contrast-enhanced, axial kidney CT images with slice thickness 3mm or less.

IRISeg Version 3.1 ("IRISeg") is a standalone software application created by Intuitive Surgical for segmentation of contrast-enhanced kidney CT images and generation of output files that can be rendered as virtual 3D models of kidney organs. IRISeg is designed to professionals ("users") with manual and machine learning (ML)-based tools for segmentation of kidney anatomy based on CT scans.

Let's break down the acceptance criteria and study details for the IRISeg device, based on the provided FDA 510(k) summary.

Device Name: IRISeg
Intended Use: Software application for image analysis and segmentation of contrast-enhanced kidney CT images, creating an output file for rendering a 3D model for pre-operative surgical planning and intraoperative display. The machine learning enabled kidney CT auto-segmentation tool is intended for adult patients with contrast-enhanced, axial kidney CT images with slice thickness 3mm or less. The output is for visual, non-diagnostic use and requires review by clinicians.

1. Table of Acceptance Criteria and Reported Device Performance

The document characterizes performance using the Sørensen–Dice coefficient (DSC) for segmentation accuracy of anatomical structures and Mean Distance to Agreement (MDA) for the collecting system. While explicit "acceptance criteria" are not given as numerical cutoffs, the reported performance demonstrates the algorithm's accuracy relative to expert consensus.

(Note: The document states "test results showed that all tests met the acceptance criteria" generally for software V&V, and then presents these quantified performance metrics for the ML algorithm. We infer that these reported intervals fulfill the internal, unstated numerical acceptance thresholds for clinical performance.)

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

• Test Set Sample Size: 81 kidney CT scans.
• Data Provenance: The document states that the clinical data for training was "sourced from clinical data processed during commercial operation of the cleared IRIS 1.0 system (K182643)." For the test set, it explicitly states "No imaging study used to verify performance was used for training; independence of training and testing data were enforced at the level of the scanning institution, namely, studies sourced from a specific institution were used for either training or testing but could not be used in testing ensured diversity in patient population, scan parameters and scanner manufacturers." This implies a retrospective study using existing clinical CT scans. The country of origin is not explicitly stated, but given the FDA submission and the use of "U.S board certified radiologist," it can be inferred that the data is likely from the U.S. or at least relevant to U.S. clinical practice. The data is retrospective.

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

• Number of Experts: Three (3) U.S. Board Certified Radiologists.
• Qualifications: U.S. Board Certified Radiologists. (No further details on years of experience or subspecialty provided beyond "Board Certified").

4. Adjudication Method for the Test Set

The ground truth was established by the "consensus of three U.S Board Certified Radiologists." This implies a form of consensus-based adjudication, but the specific mechanics (e.g., majority vote, sequential review with final agreement, arbitration by a fourth reader) are not detailed beyond "consensus."

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

No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not reported in this summary. The AI performance was evaluated in a standalone manner against expert consensus ground truth. The device output is explicitly non-diagnostic and requires review by clinicians, emphasizing a human-in-the-loop workflow, but the study focused on the algorithm's raw segmentation accuracy.

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

Yes, a standalone performance study was conducted. The performance metrics (DSC and MDA) characterize the ML algorithm's output directly when compared to expert-derived ground truth. The summary states, "Performance was evaluated by comparing segmentations generated by the kidney CT machine learning algorithm against segmentations generated by a consensus of three U.S Board Certified Radiologists for the same imaging study." This is a direct measurement of the algorithm's standalone accuracy.

7. Type of Ground Truth Used

The ground truth used was expert consensus by three U.S. Board Certified Radiologists, based on their segmentation of the medical images.

8. The Sample Size for the Training Set

The sample size for the training set is not explicitly stated in the provided summary. It states the model was "trained on segmented kidney CT models that were sourced from clinical data processed during commercial operation of the cleared IRIS 1.0 system (K182643)."

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

The ground truth for the training set was established by review from one U.S. board certified radiologist per 3D model. The summary states: "Each 3D model was reviewed by one U.S board certified radiologist."

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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 EndoWrist SP Instruments during urologic 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.

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 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 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 a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera 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 camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera 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 camera. 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 camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "general thoracoscopic surgical procedures" to the indications, and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for Use.

This document is a 510(k) summary for the da Vinci SP Surgical System. It details the device's indications for use and presents performance data to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria (Performance Endpoints) and Reported Device Performance

The acceptance criteria for the clinical study were primarily based on safety and performance endpoints demonstrated by the incidence of adverse events and the rate of conversion to other surgical methods. While specific numerical acceptance thresholds are not explicitly stated as "acceptance criteria" in a table format, the study's success is defined by these metrics. The performance data presented indicates that the device met these implicit criteria by demonstrating favorable outcomes.

Note on "Acceptance Criteria": The document does not explicitly present a pre-defined table of numerical acceptance criteria. Instead, it describes the demonstration of safety and performance (low adverse event rates, zero conversions) and then performs a comparison to published literature for the predicate device, showing that the 95% confidence intervals overlap. This indicates that performance was considered acceptable if it was similar to that of the already-cleared multiport robotic systems.

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

• Clinical Study Test Set (Prospective, Multicenter, Single-Arm):

  • Total Subjects: 32 subjects
  • Thymectomy Cohort: 13 subjects
  • Lobectomy Cohort: 19 subjects
  • Data Provenance: United States (6 institutions), prospective.

• Pre-clinical Study Test Set (Cadaver and Animal Performance Testing):

  • Subjects: 3 independent practicing surgeons
  • Procedures: 18 surgical procedures total (5 procedures per surgeon in a cadaver model, 1 procedure per surgeon in a porcine model).
  • Data Provenance: Not explicitly stated, but typically conducted in a controlled lab/testing environment.

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

• Clinical Study: The ground truth for the clinical study was established by the clinical outcomes observed in patients undergoing surgery using the da Vinci SP Surgical System. This includes intra-operative observations and post-operative follow-up (30-day). The data was collected by the treating physicians and study staff at 6 institutions in the United States. The qualifications of these clinicians are not explicitly detailed, but they are implied to be "trained physicians" in an "operating room environment" as per the Indications for Use.
• Pre-clinical Study: "Three (3) independent practicing surgeons participated" in this study. Their specific qualifications (e.g., years of experience, subspecialty) are not provided beyond "independent practicing surgeons." The "success criteria" for each procedure were "deemed surgically acceptable upon visual inspection" - implying these surgeons assessed the outcome as part of establishing the ground truth for this phase.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. The study was a "single-arm" study. Adverse events were reported, and it's mentioned that none were "deemed to be device related." This suggests some level of medical review or adjudication, likely by the study investigators or a clinical events committee, but the specific process (e.g., 2+1, 3+1) is not detailed.
• Pre-clinical Study: The surgeons performed the procedures and assessed completion/acceptability. No independent adjudication method is described beyond the surgeons performing the procedures and judging the outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC study was performed. The device is a surgical system, not an AI-assisted diagnostic or image interpretation tool for "human readers." Therefore, this section is not applicable. The comparison was between the da Vinci SP system and existing multiport robotic systems (literature comparison) or traditional open/VATS procedures in terms of surgical outcomes.

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

This is not applicable. The da Vinci SP Surgical System is a robotic surgical platform that requires human operation (surgeon-in-the-loop). It is not an algorithm performing a task autonomously.

7. The Type of Ground Truth Used

• Clinical Study:
  • Safety Ground Truth: Real-world clinical outcomes in patients (intra-operative and post-operative adverse events, complications, readmissions, reoperations, mortality).
  • Performance Ground Truth: Successful completion of surgical procedures without conversion, operative metrics (time, blood loss), and critical clinical parameters like positive surgical margins.
• Pre-clinical Study: Surgical outcomes in cadaver and porcine models assessed by surgeons based on defined procedure completion criteria (e.g., "complete dissection," "sufficient lymph node dissection," "hemostasis maintained," "critical anatomy identified").

8. The Sample Size for the Training Set

No specific "training set" for an AI model is mentioned as this device is a surgical system, not an AI/ML algorithm. The development and validation of such a complex system would involve extensive engineering, bench testing, pre-clinical trials (as described), and then clinical studies. The design and validation relied on established medical device development processes and prior knowledge from the predicate device (da Vinci Xi Surgical System).

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

Not applicable, as there is no mention of an AI/ML training set in the context of this device's submission. The "ground truth" for the device's design verification and validation would have been established through engineering specifications, biomechanical principles, surgical anatomical knowledge, and established clinical practices, leading to the performance criteria tested in the pre-clinical and clinical studies.

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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 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.

Endo Wrist SP Instruments:

Intuitive Surgical Endo Wrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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 surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign turnors 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 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 a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera 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 camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera 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 camera. 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 camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use. Simple prostatectomy is a "covered" procedure under radical prostatectomy as an "umbrella" procedure. This 510(k) also includes the addition of performance data (cadaver) for "transvesical prostatectomy" as validated approach for prostatectomy in the Performance Data section of the User Manual.

The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It primarily discusses a labeling modification to add "simple prostatectomy" as a representative procedure and the justification for this change. The document does not describe acceptance criteria for a device performance study in the typical sense of a new device validation with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing performance data from literature for different prostatectomy approaches.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance (as inferred from the provided text):

The "acceptance criteria" here are not explicitly stated numerical thresholds for performance. Instead, the inherent acceptance criterion is that the new procedure ("transvesical prostatectomy" for both simple and radical cases) performed with the da Vinci SP Surgical System demonstrates similar clinical outcomes to previously cleared prostatectomy approaches (extraperitoneal and transabdominal radical prostatectomy) performed with the same device. This demonstrates "substantial equivalence" and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Description: The "test set" here is composed of peer-reviewed literature and a cadaver study.
  • Literature Review: 11 primary publications for transvesical prostatectomy (8 for TVSP, 3 for TVRP) with a total of ~428 patients (247 for TVSP, 181 for TVRP).
  • Comparison Literature: 10 publications for extraperitoneal radical prostatectomy (EPRP) with ~1,259 patients and 7 publications for transabdominal radical prostatectomy (TARP) with ~649 patients.
• Data Provenance: Retrospective, collected from peer-reviewed scientific literature published between January 1, 2018, and January 7, 2023. The countries of origin are not specified, but peer-reviewed literature typically encompasses international data.
• Cadaver Study: One male cadaver was used. This was a prospective study to confirm instrument access and motion.

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

• Cadaver Study: The document states that "Design validation testing was performed... Evaluation of the ability to provide robotic and laparoscopic instrument access... was confirmed and an assessment of instrument motion... was performed." It doesn't explicitly state the number or qualifications of the experts performing this evaluation for the cadaver study, but it implies trained medical professionals (likely surgeons or surgical engineers) would conduct such validation.
• Literature Review: The ground truth for the literature review is based on reported clinical outcomes from published studies. The "experts" in this context are the authors of the peer-reviewed articles, who are typically surgeons specializing in urology and robotic surgery. Their qualifications and number are variable across the 28 referenced publications.

4. Adjudication Method for the Test Set:

• Literature Review: The method involved systematic searching of Scopus, Embase, and PubMed databases, followed by systematic literature screening. For comparative effectiveness, "all primary publications reporting relevant clinical outcomes for transvesical simple/radical prostatectomy performed using the da Vinci SP Surgical System were included." For the predicate approaches, publications with "50 or more patients in at least one study arm were included." This suggests a criteria-based inclusion/exclusion process for publications, but a formal "adjudication method" beyond standard systematic review practices (e.g., dual review and consensus) is not explicitly detailed.
• Cadaver Study: No adjudication method is described beyond the inherent observation and confirmation by the performing team.

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

No, an MRMC comparative effectiveness study was not done. The study relies on comparing aggregated historical clinical outcomes from published literature and a single cadaver study, not on human readers interpreting cases with or without AI assistance. The device is a surgical system, not an AI diagnostic or assistive tool in the traditional sense of image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

The "da Vinci SP Surgical System" is a robotic surgical platform; it is a human-in-the-loop device by its very nature (a surgeon controls the system). Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable or relevant to this device.

7. The Type of Ground Truth Used:

• Cadaver Study: Direct observation and confirmation of instrument access, motion, and robustness within a cadaveric model.
• Literature Review: Clinical outcomes data reported in peer-reviewed publications. This includes various metrics collected by the original study authors, such as operative time, estimated blood loss (EBL), complication rates (intraoperative, 30-day postoperative, major), length of stay, readmission rate, urinary retention, continence rate, catheterization time, positive surgical margins, and mortality. These are patient outcomes, representing a form of "ground truth" for clinical performance.

8. The Sample Size for the Training Set:

The 510(k) summary does not describe any "training set" in the context of an AI/ML algorithm development. The device is a surgical system, not an AI algorithm that learns from data. The prior clinical experience with the da Vinci SP System and its predicate devices, as well as general surgical knowledge, would constitute the underlying "knowledge base" for its design and intended use, but not a formally defined "training set" for an algorithm.

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

Not applicable, as there is no described AI training set.

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The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediativ use. The device can be used with staple line or tissue buttressing material.

The Intuitive Surgical SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other Stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.

The Intuitive Surgical EndoWrist Stapler 30 Staplers, EndoWrist Stapler 45 Staplers, SureForm 45 Staplers, SureForm 60 Stapler, and 8 mm SureForm Staplers are fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Reloads consist of a single-use cartridge that contains multiple staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are sterile, single use devices that are offered in various configurations by product family. Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses.

This document describes a 510(k) submission for surgical stapling systems and their reloads, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study data for AI/ML performance, sample sizes for test/training sets, expert consensus, MRMC studies, and ground truth establishment for AI/ML models is not applicable to this submission.

The 510(k) submission [K222839] for the Intuitive Surgical Inc. EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, and 8 mm SureForm 30 System concerns a modification (addition of a contraindication) to already marketed surgical stapling devices. The review focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and usability testing, rather than performance evaluation of an AI algorithm.

The "Usability testing" mentioned in the document is for the human use of the device, confirming surgeons can correctly select and safely use the device with the revised labeling, not for the performance of an AI algorithm.

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Upon intravenous administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and nearinfrared fluorescence imaging. The da Vinci 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, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The da Vinci Firefly Imaging System provides visualization in two modes: standard, visible-light imaging mode and a near-infrared fluorescence imaging mode, consisting of either a black-and-white surgical image or completely black background with the nearinfrared fluorescence depicted in a color overlay. For near-infrared fluorescence imaging, indocyanine green (ICG) fluorescence imaging agent is required.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size for the test set used in the "Delta validation testing" or "Delta design verification testing."

The data provenance is also not explicitly detailed. It can be inferred that the testing was conducted internally by Intuitive Surgical, Inc. as part of their design verification and validation processes. There is no mention of country of origin of the data or whether it was retrospective or prospective.

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

The provided text does not provide information regarding the number of experts used or their specific qualifications for establishing ground truth within these tests. The tests are described as "validation testing" and "design verification testing" against "design requirements and specifications" and "clinical applications test cases," suggesting an internal product-centric validation rather than a clinical ground truth established by external experts in an MRMC study.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method like 2+1 or 3+1. The description of testing ("met the acceptance criteria for all of the design requirements and specifications") implies a direct assessment against predefined engineering or performance metrics rather than a consensus-based review of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is an imaging system (da Vinci Firefly Imaging System), not an AI-assisted diagnostic tool that directly aids human readers in interpretation. The filing describes a modification to an existing imaging system (change in excitation wavelength from 805nm to 785nm), and the testing focused on verifying the performance of this modified system against its design specifications and maintaining substantial equivalence. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system used during surgery, and its functionality involves providing real-time visible and near-infrared fluorescence imaging to surgeons. It is inherently a human-in-the-loop device as it provides visual information for a surgeon to interpret and act upon. The text does not describe any standalone algorithmic performance without human interpretation.

7. The Type of Ground Truth Used

The "ground truth" for the testing described appears to be based on engineering design requirements and specifications for the imaging system's performance, particularly related to the 785nm fluorescence system, illumination, and compatibility. It also references "Firefly Clinical Applications test cases," which suggests scenarios designed to evaluate the system's performance in clinical contexts, likely validated against anticipated imaging results or known technical benchmarks. It does not mention expert consensus, pathology, or outcomes data as the primary ground truth for this particular submission.

8. The Sample Size for the Training Set

The provided text does not mention a training set because this submission describes a modification to a medical device (an imaging system, specifically a change in laser wavelength) and not an AI/ML algorithm that would typically require a training set. The testing performed was for verification and validation of the hardware change.

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

Since there is no mention of a training set, the method for establishing its ground truth is not applicable to this document.

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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 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 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 subject da Vinci SP Surgical System, Model SP1098, uses advanced robotic technology to facilitate accurate movement of EndoWrist SP™ Instruments through a single surgical port. The System includes three major subsystems (Surgeon Console, Vision Cart, Patient Cart), which are used with instruments and accessories. The system is software controlled.

There are two types of changes that are the focus of this 510(k). The first change is a modification to the Surgeon Console's FootSwitch Panel. The second change is an update to the System Software.

The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It details modifications made to the system and the performance data used to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information related to acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly present a table of concrete, quantitative acceptance criteria for device performance in the typical sense of a diagnostic or algorithmic output (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria relate to the design and safety validation of a surgical robotic system after modifications. The reported performance is whether these criteria were met.

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

• Human Factors Validation: "representative end users (participants)" were used. The exact number of participants is not specified, but the study involved a "mix of RASD (Robotically Assisted Surgical Device) and non-RASD experienced surgeons."
• Design Validation (Animal/Cadaver): "Tests with animal model and cadaver models were performed." The number of animal/cadaver models is not specified.
• Data Provenance: Not explicitly stated, but given the company is based in Sunnyvale, CA, and it's an FDA submission, it's highly likely the studies were conducted in the US. The studies are prospective in nature, as they involve testing human performance with the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not a diagnostic device where "ground truth" is established by experts for a specific diagnostic outcome. For the human factors validation, the "ground truth" is implicitly the objective evaluation of task completion and safety, as assessed by the study design and observers. The experts involved are the "representative end users (participants)," who are "RASD and non-RASD experienced surgeons." Their specific qualifications beyond experience type are not detailed.

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

Not applicable in the typical sense of adjudicating diagnostic labels. The human factors study involved observing participants performing tasks, and evaluating their performance against predefined safety and effectiveness criteria. There is no mention of an adjudication panel for discordant observations.

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 a diagnostic imaging device with an AI component assisting human readers. It is a surgical robotic system.

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

This refers to a surgical robotic system, which inherently involves human-in-the-loop operation (the surgeon). The "system software" modifications were evaluated (software design verification), but the device itself is not a standalone algorithm. Its performance is always in conjunction with a human operator.

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

As mentioned in point 3, this is not a diagnostic device. For the human factors validation, the "ground truth" is based on:
* Objective task performance: Whether critical and essential tasks were correctly and safely completed.
* Observation of use errors: Identification and classification of any errors made by the participants.
* Assessment of residual risks: Evaluation of whether any identified risks (pre- or post-mitigation) are acceptable.
* Subjective feedback: Participant opinions on usability and safety.

8. The sample size for the training set

Not applicable. This is a surgical robotic system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "system software" updates are based on design and engineering principles rather than statistical learning from a large dataset.

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

Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's development (its design inputs and specifications) would have been established through engineering requirements, risk analysis, clinical needs assessment, and regulatory standards.

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The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

The da Vinci Xi Hasson Cone is a cone-shaped device which is intended to be used in endoscopic surgery to anchor a port of entry (i.e., cannula) to the patient. During Hasson, or open, surgical techniques, the user places a Hasson Cone in the opening of the body wall. The cannula shaft is inserted into the cone, effectively increasing the diameter of the cannula to the contour of the incision made in the body wall.

The Hasson Cone will be offered in two sizes; 8 mm and 12 mm & Stapler.

The provided document is a 510(k) premarket notification for the Intuitive Surgical da Vinci Xi Hasson Cone. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets specific performance criteria in the format requested.

The document states that "Performance data (bench and animal testing) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." It lists the types of testing conducted but does not provide specific numerical acceptance criteria or the reported device performance against those criteria.

Therefore, I cannot populate the table or provide detailed answers to many of the questions as the information is not present in the provided text. I will indicate where the information is not available.

Description of the Acceptance Criteria and Study:

The document broadly states that performance data (bench and animal testing) demonstrated that the da Vinci Xi Hasson Cone is substantially equivalent to a predicate device and that its design output meets design input requirements. The testing included:

• Dimensional measurements
• Mechanical and functional verification
• Simulated use in animal models
• Human factors assessment

1. A table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified in the document. The document mentions "animal and cadaveric models" for design validation testing but does not provide quantities.
• Data provenance: Not specified. Testing was described as "bench" and "animal and cadaveric models," suggesting prospective
  testing, but detailed provenance (e.g., country of origin) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. The context of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus on images) does not directly apply to the mechanical and functional device testing described. The "experts" would likely be the engineers and perhaps surgeons involved in the animal validation, but their number and specific qualifications are not detailed.

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

• Not applicable/Not specified. This is typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. For device performance testing, the "adjudication" would be based on meeting predefined engineering specifications and functional outcomes.

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

• No. The document describes a medical device (Hasson cone) used in laparoscopic surgery, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• Not applicable. This device is a physical surgical accessory, not an algorithm.

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

• The "ground truth" for this type of device testing is adherence to engineering specifications, functional performance in simulated environments (bench testing), and successful operation within animal/cadaveric models. It's based on objective measurements and observed physical outcomes rather than expert interpretation of diagnostic data or pathology.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

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