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The Intuitive Surgical Endoscopic Instrument Control System, Model IS4000) is intended to 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, 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 laparosopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric 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.

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" general indication for the da Vinci Xi Surgical System (K131861): Lobectomy, Mediastinal Mass Resection, Thymectomy, Segmentectomy, Wedge Resection and Lymphadenectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided text describes a 510(k) premarket notification for the Da Vinci Xi Surgical System, focusing on a labeling modification to include additional specific procedures under existing general indications for use. This involves demonstrating substantial equivalence to predicate devices, rather than establishing entirely new performance criteria for a novel device. Therefore, the information typically requested regarding acceptance criteria and a study proving a new device meets those criteria is not directly applicable in this context as new performance metrics are not being established.

However, I can extract and structure the available information about the demonstration of suitability for the expanded indications, which functions as the system's "acceptance" for these new procedures.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly demonstrating that the da Vinci Xi Surgical System, when used for the expanded "umbrella" and "covered" procedures, shows comparable or improved patient outcomes (mortality, complications, blood loss, length of stay, operative time) compared to established surgical methods (Open and VATS procedures).

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

• Pre-Clinical Animal Study Data:

  • Sample Size: A total of 20 animals were used in three evaluations.
  • Provenance: This was a preclinical study. Specific country of origin is not mentioned but it's an internal study supporting the submission.

• Clinical Study Data (Human Data):

  • Sample Size: The clinical data relies on published retrospective, comparative, and single-arm studies.
    • Lobectomy: The provided table (Table 1) lists 18 publications with varying sample sizes per study group (ranging from N=22 to N=20,238 for comparison groups and N=22 to N=2,498 for da Vinci groups). The total number of patients across all studies is not explicitly summed, but it is substantial.
    • Mediastinal Mass Resection: Table 2 lists 7 publications with sample sizes ranging from N=14 to N=75 (da Vinci groups).
    • Thymectomy: Table 3 lists 15 publications with sample sizes ranging from N=6 to N=125 (da Vinci groups).
  • Provenance: These are published clinical data. The specific countries of origin are not detailed in this summary but are derived from a global body of medical literature. These studies are retrospective, comparative, and single-arm.

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

There is no mention of independent experts being used to establish a "ground truth" for a test set in the traditional sense of an AI/ML device evaluating images or signals. The "ground truth" or clinical outcome data in this context comes from the published clinical studies themselves, where the outcomes (e.g., mortality, complications, operative time) were determined and reported by the treating physicians and study authors. The qualifications of these physicians are implicitly high, as they are authors of peer-reviewed clinical publications performing complex surgical procedures.

4. Adjudication Method for the Test Set

Not applicable. This submission relies on aggregated and summarized outcomes from published clinical literature, not on a new test set requiring expert adjudication.

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

No MRMC comparative effectiveness study was done. The submission is not for an AI-assisted diagnostic or interpretative device where human readers interact with AI. It's for a surgical system where the performance is measured by patient outcomes.

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

Not applicable. The da Vinci Xi Surgical System is a tool used by human surgeons; it is not a standalone AI device performing tasks without human intervention. Its performance is measured in the context of human surgeons using the system.

7. The Type of Ground Truth Used

The "ground truth" used is outcomes data (e.g., mortality, complication rates, operative times, length of stay, blood loss) as reported in published clinical studies. This data represents real-world clinical results rather than an independent expert consensus on a test set or pathology reports for specific diagnoses.

8. The Sample Size for the Training Set

Not applicable. The da Vinci Xi Surgical System is an electro-mechanical system controlled by software, not a machine learning algorithm that undergoes a "training phase" to learn from a specific dataset in the way an AI diagnostic tool would. Its development and refinement are based on engineering principles and clinical experience, not a "training set" for an algorithm in the AI sense.

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

Not applicable, as there is no "training set" for an algorithm in the context of this device. The system's design and functionality are established through engineering, preclinical testing, and clinical experience, not algorithmic training.

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