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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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