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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 surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant turnors 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® 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 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, electromechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist SP Instruments and Camera Instrument by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and surgical instrumentation, along with icons and other user interface features.

The Vision Cart includes the supporting electronic and video processing equipment for the system.

The Patient Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, threedimensional view of the patient anatomy. A suite of EndoWrist SP Instruments can be attached to and detached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instrument and up to three surgical instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an obturator, a seal, an entry guide, disposable tips for selected instruments, instrument sheaths, and a drape are needed to perform procedures with the system.

The EndoWrist SP Instruments come in various configurations such as graspers, scissors, and needle drivers. The EndoWrist SP instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y-Z movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The EndoWrist SP Instruments can be used only with the SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

The EndoWrist SP Camera Instrument is a reusable endoscope that provides a stereo image of the surgical site. Like the instruments, the distal end includes multiple joints that provide the flexibility needed for use with a single-port system.

The provided FDA 510(k) summary (K182371) describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories. This document primarily focuses on demonstrating substantial equivalence to predicate devices for use in transoral otolaryngology surgical (TORS) procedures for benign and malignant (T1 and T2) oropharyngeal tumors.

It's important to note that this document does not describe an AI/ML-driven device; rather, it details a robotic surgical system that assists human surgeons. Therefore, information related to AI-specific criteria (like AI vs. human reader improvement, standalone AI performance, training set sample size/ground truth) is not applicable or present in this filing.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text, specifically for the expansion of indications to include TORS:

Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are not explicitly listed in a separate table titled "acceptance criteria" but are implicitly derived from the comparative effectiveness study against a predicate device and the clinical study endpoints for safety and performance. The FDA's determination of substantial equivalence relies on the new device being as safe and effective as the predicate and not raising new questions of safety or effectiveness.

*Note: Confidence intervals for da Vinci SP are Wilson Score 95% CI where applicable, and Agresti Coull 95% CI for conversion rate.

Study Design Details

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

• Clinical Study (Confirmatory):
  • Sample Size: N=33 subjects for the da Vinci SP Surgical System for TORS.
  • Data Provenance: Prospective, multicenter, single-arm clinical study conducted in the United States (NCT03049280, IDE #G160251).
• Pre-clinical Study (Cadaver and Animal Testing):
  • Cadavers: A sufficient number to demonstrate anatomical access and reach.
  • Live Porcine Models: A sufficient number to assess safety and performance in live tissue.
  • Data Provenance: Conducted as part of the pre-clinical investigation to support the expanded indication.

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

• Pre-clinical Study (Cadaver and Animal Testing): Three (3) independent practicing surgeons participated. No specific qualifications beyond "independent practicing surgeons" are provided. These surgeons evaluated their ability to perform surgical tasks and procedures.
• Clinical Study: The "ground truth" for clinical outcomes (e.g., successful procedure, complications) would be established by the treating physicians and study investigators at the three participating institutions, typically qualified medical professionals (surgeons, oncologists, etc.), though their specific experience level is not detailed in this summary.

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

The text does not explicitly describe an adjudication method for disagreements among experts or for clinical endpoints. In the cadaver/animal study, surgeons completed questionnaires, implying individual assessment. For clinical studies, safety and performance outcomes are typically recorded directly by the sites and reviewed by study monitors and investigators.

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

• MRMC Study: No, this device is a robotic surgical system, not an AI diagnostic tool involving "human readers." Therefore, an MRMC study and effect size relating to human readers with/without AI assistance are not applicable.

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

• No, this device is a surgical assistance system that requires a human surgeon "in the loop" for all aspects of its operation. Standalone algorithm performance is not applicable.

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

• Pre-clinical Testing: Surgical success criteria (e.g., resection volume, boundary achievement, critical anatomy identification, hemostasis, no trauma) as assessed by participating surgeons. This aligns with a form of expert assessment/consensus on surgical outcomes in non-human models.
• Clinical Study: Outcomes data from human subjects, including operative parameters (e.g., operative time, blood loss), safety endpoints (device-related adverse events, intraoperative complications), and clinical outcomes (e.g., conversion to open surgery, hospital stay, mortality, readmission, reoperation, postoperative complications). Pathological reports would be part of verifying tumor classification (T1, T2) which is part of the inclusion criteria, but the "ground truth" for the device's performance itself is the clinical outcomes.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a distinct "training set" in the context of machine learning. The device design and refinement would be based on engineering principles and iterative testing, not a data-driven training process in the AI sense.

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

• Not applicable as it's not an AI/ML device.

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da Vinci SP® Surgical System, Model SP1098:
The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated 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 SPTM 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 incision laparoach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. 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, electromechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist SP Instruments and Camera Instrument by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes the supporting electronic and video processing equipment for the system.

The Patient Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, threedimensional view of the patient anatomy. A suite of EndoWrist SP Instruments can be attached to and detached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instrument and up to three surgical instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an obturator, a seal, an entry guide, disposable tips for selected instruments, instrument sheaths, and a drape are needed to perform procedures with the system.

The EndoWrist SP Instruments come in various configurations such as graspers, scissors, and needle drivers. The EndoWrist SP instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y-Z movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The EndoWrist SP Instruments can be used only with the SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

The EndoWrist SP Camera Instrument is a reusable endoscope that provides a stereo image of the surgical site. Like the instruments, the distal end includes multiple joints that provide the flexibility needed for use with a single-port system.

This document describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (referred to as "the device" or "SP1098 system") and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device (Model SP999) and that design output meets design input requirements. The "performance" is generally reported as successful completion of these tests, confirming the device's ability to operate as intended and safely.

Below is a summary of the performance studies conducted and the reported outcomes:

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

• Cadaver and Animal Performance Testing:

  • Cadaver Models: 6 cadaver procedures were performed.
  • Porcine Models: 3 porcine (live animal) procedures were performed.
  • Surgeons: 3 independent practicing surgeons participated. Each performed 7 urologic procedures in cadaver models and 5 representative and simulated procedures in porcine models, totaling 36 surgical procedures.
  • Data Provenance: Not explicitly stated, but cadaver and porcine models are used, generally implying controlled laboratory or surgical simulation environments. The participants are "independent practicing surgeons," suggesting their experience is relevant to real-world clinical practice, but the tests themselves were in simulated environments. It's a prospective study in the sense that the device was specifically tested in these models.

• Human Factors (HF) Performance Testing:

  • Participants: A total of 15 surgical teams (surgeon and patient-side assistant) and 15 prep teams (scrub tech and circulating nurse).
  • Data Provenance: The study was conducted in a "simulated operating room environment," involving controlled, prospective testing scenarios.

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

• Cadaver and Animal Performance Testing: The "ground truth" for the success criteria (e.g., "Anastomosis complete and deemed acceptable upon visual inspection," "Critical anatomy identified," "Hemostasis maintained") was implicitly established by the 3 independent practicing surgeons who performed the procedures and evaluated the outcomes. Their qualifications are stated as "independent practicing surgeons," implying they are qualified by their profession and experience to make these assessments.
• Human Factors Testing: The "usability risk analysis was developed with feedback from internal functional group experts." The qualifications of these internal experts are not specifically detailed (e.g., years of experience, specific certifications), but they are described as "functional group experts."

4. Adjudication Method for the Test Set

• Cadaver and Animal Performance Testing: The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for the surgical outcomes. The success criteria imply a direct assessment by the performing surgeons. It might be assumed that for critical assessments like "acceptable upon visual inspection," the surgeons' professional judgment served as the "adjudication."
• Human Factors Testing: "The SP1098 usability risk analysis was updated throughout the design process as formative testing was conducted, system design was iterated, new use errors were identified, and new mitigations were implemented." This suggests an iterative process where identified issues were reviewed and addressed, but a specific "adjudication method" for individual use errors is not detailed. Objective performance data and subjective feedback were collected and presumably interpreted by human factors experts.

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 MRMC comparative effectiveness study was done. This device is a surgical system, not an AI-assisted diagnostic or interpretation tool for "readers." The performance studies focused on the surgical system's ability to perform procedures, safety, and usability.

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

• Not applicable. The device is a surgical system that requires a human surgeon for operation (human-in-the-loop). It is not a standalone algorithm. The "standalone" aspect that could be considered is the system's electromechanical function and software control, which were tested via bench performance without direct human interaction for some aspects, but the overall product is user-dependent.

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

• For Cadaver and Animal Testing: The ground truth was based on the expert assessment and visual inspection of the surgical outcomes by "independent practicing surgeons" against predefined success criteria (e.g., "Anastomosis complete and deemed acceptable," "Kidney completely freed," "Hemostasis maintained"). No mention of pathology or long-term outcomes data for these specific tests.
• For Human Factors Testing: The ground truth for identifying usability issues and risks was based on observations of user performance (objective data) and user feedback (subjective data) during simulated scenarios, interpreted by human factors experts.

8. The Sample Size for the Training Set

• Not explicitly stated for an AI/algorithm context. This device is a robotic surgical system, not a machine learning model that undergoes "training" in the traditional sense with a distinct training dataset. Its development likely involved iterative design and testing using various models and prototypes, which could be seen as its "training" or development phase.

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

• Not applicable in the context of an AI training set for this type of medical device. The "ground truth" for the device's design and engineering development (analogous to a training set in ML) would have been established through engineering specifications, design input requirements, and previous historical data/knowledge from predicate devices (e.g., da Vinci SP999, da Vinci Xi IS4000). These requirements and the "truth" of their fulfillment were then verified through the detailed bench, cadaver, animal, and human factors testing described.

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To assist in the accurate control of endoscopic instruments in minimally invasive surgery.

da Vincio SpTM Surgical System, Model SP999: The Intuitive Surgical Endoscopic Instrument Control System (da Vincio Sp™ Surgical System, Model SP999) 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. 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 Vincio Sp™ Surgical System, Model SP999, 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 incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. 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 SP999 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model SP999 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with a Camera Instrument, EndoWrist Sp Instruments, and Accessories.

Acceptance Criteria and Device Performance Study for da Vinci® Sp™ Surgical System, Model SP999

The provided 510(k) summary outlines the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the da Vinci® Sp™ Surgical System, Model SP999, to its predicate devices. The studies primarily focused on mechanical, electrical, and functional verification, safety, and simulated use in animal and cadaver models.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were established qualitatively through various tests to ensure the new device performed equivalently or acceptably compared to the predicate device. The performance was assessed based on the successful completion of surgical tasks and overall system functionality.

2. Sample Size and Data Provenance

• Test Set for Cadaver and Animal Validations (Comparative Study):

  • Sample Size: 5 independent practicing surgeons. Each surgeon performed 7 urologic procedures in a cadaver model and 6 representative procedure steps in a porcine model for each system (SP999 and IS3000), totaling 65 surgical procedures per system. The individual procedures described in the table are the cases.
  • Data Provenance: Not explicitly stated, but likely conducted in a controlled lab/testing environment, potentially in the US where the company is based. The data is prospective for this specific study.

• Test Set for Cadaver and Animal Validations (Initial SP999 Evaluation):

  • Sample Size: 11 procedures (5 cadaver, 6 porcine). The sample size applies to the number of procedures, not necessarily unique animals/cadavers, although it mentions "sample size = 1" in parentheses for the overall system evaluation, which is ambiguous but could imply one animal for each type of procedure or one overall comprehensive animal model.
  • Data Provenance: Not explicitly stated, but likely from controlled lab/testing environments.

• Test Set for Human Factors Evaluation:

  • Sample Size: 15 teams of users (surgeons and patient side assistants). Each team represents one "case" for the human factors study.
  • Data Provenance: Conducted in a simulated OR environment. Likely within the US. This is prospective data.

• Test Set for Feasibility Study:

  • Sample Size: 19 human clinical cases (11 prostatectomies, 4 nephrectomies, 4 partial nephrectomies).
  • Data Provenance: "OUS feasibility study" (Outside the US), indicating an international origin. This is retrospective for the purpose of the 510(k) submission, as it was conducted with a prototype and submitted as supplementary evidence, not primary for SE.

3. Number of Experts and Qualifications for Ground Truth

• For Cadaver and Animal Validations (Comparative Study):

  • Number of Experts: 5 independent practicing surgeons.
  • Qualifications: "independent practicing surgeons." Specific experience or specialization is only noted as "urologic surgical procedures." Given the procedures (pyeloplasty, nephrectomy, prostatectomy, lymphadenectomy), they are likely urologists with relevant surgical experience.

• For Cadaver and Animal Validations (Initial SP999 Evaluation):

  • Number of Experts: Not explicitly stated. Procedures were performed by "clinical development engineers." These are likely internal experts with specialized knowledge of the device and surgical procedures, but their clinical credentialing as surgeons isn't mentioned for this specific evaluation phase (they are performing the initial tests, not the comparative reader study).

• For Human Factors Evaluation:

  • Number of Experts/Users: 15 surgical urologists and 15 patient side assistants.
  • Qualifications: Surgical urologists with varying experience (2 - 30 years in surgical practice, 13 - 1000 robotic surgical cases). Patient side assistants also varied in experience (55 - 40,000 cases, 0 - 9000 robotic patient side cases).

• For Feasibility Study:

  • Number of Experts/Users: Not explicitly stated for each case, but implies trained surgeons performed the procedures.
  • Qualifications: Unspecified, but performing "human clinical cases" implies they were qualified surgeons.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method like "2+1" or "3+1" for establishing ground truth for the test sets. Instead, success criteria for each procedure were defined, and the performance against these criteria was observed and evaluated by the participating surgeons themselves (in the comparative study) or by clinical development engineers (in the initial evaluation). For human factors, objective performance data, use-errors, close calls, and subjective feedback were collected.

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

• Was a MRMC comparative effectiveness study done? Yes, a comparative study was conducted where five independent practicing surgeons (multiple readers) performed a comprehensive set of urologic surgical procedures (multiple cases) using both the SP999 (subject) and the IS3000 (predicate) systems.

• Effect size of how much human readers improve with AI vs without AI assistance: This study does not evaluate AI assistance. The da Vinci system is a robotic surgical system that assists surgeons, but the context here is comparing a new version of the robotic system (SP999) against an older version (IS3000), not comparing human readers with and without AI assistance for interpretation tasks (e.g., radiology). The goal was to prove the substantial equivalence of the new robotic system, not to quantify improvement in human diagnostic performance with AI. The effect measured was the ability of surgeons to successfully complete defined surgical tasks with both systems. The document implies no statistically significant difference or inferiority of the new system compared to the predicate was found, as it concluded substantial equivalence. Specific quantitative improvements of surgeons using one system over the other are not detailed.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is a surgical system that requires human interaction, not a standalone diagnostic algorithm. The da Vinci system is not an AI algorithm operating independently; it is a human-controlled, electro-mechanical system.

7. Type of Ground Truth Used

• Bench Verifications: Engineering specifications, design requirements, and industry standards as the ground truth for mechanical, electrical, and functional performance.
• Cadaver and Animal Validations: Defined "success criteria" for each surgical procedure (e.g., "Anastomosis complete with no visible gaps," "Kidney completely freed"). The completion of these criteria by the surgeons or engineers served as the ground truth for performance. Tissue examination and physiological responses (e.g., hemostasis) in live animals also contribute to this.
• Human Factors Evaluation: Observational data (user's ability to complete tasks, identified use-errors, close calls, difficulties) and subjective feedback (ratings, interviews) were used to assess safety, usability, and effectiveness, with the "ground truth" being defined safe and effective operation based on risk analysis.
• Feasibility Study: 30-day post-operative outcomes on human patients. This is outcome data, serving as a form of ground truth for safety and effectiveness in a human clinical setting.

8. Sample Size for the Training Set

The document does not identify a distinct "training set" in the context of an algorithm or machine learning. The da Vinci system is a robotic system, and its development involves iterative design, testing, and feedback, rather than traditional machine learning training. The information provided describes verification and validation studies.

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

Since there is no identified "training set" for an algorithm in the machine learning sense, this question is not applicable. The development of the da Vinci SP999 system involved engineering design and testing, where the "ground truth" for each component and system feature was established by engineering specifications, regulatory standards, and clinical input from experienced surgeons guiding the design process. Formative testing and an earlier clinical investigation provided feedback that led to design iterations and improvements.

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