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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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, 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.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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, 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 procedure under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294) and the associated labeling claims: Gastrectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided document describes a 510(k) submission for a labeling modification of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) to include "Gastrectomy" as a recognized procedure under the existing "general laparoscopic surgical procedures" indication for use. This is explicitly stated as a labeling modification only, with no changes to the technological characteristics of the cleared devices. As such, the "acceptance criteria" and "device performance" in a traditional sense (e.g., diagnostic accuracy, sensitivity, specificity) for a novel device or AI algorithm are not applicable here.

Instead, the study aims to demonstrate that adding "Gastrectomy" to the labeling does not introduce new safety or effectiveness concerns compared to the already cleared general laparoscopic indications, and that the da Vinci systems are substantially equivalent for this new labeled use.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a labeling modification and not a new device or AI algorithm with specific performance metrics like accuracy, sensitivity, or specificity, there are no predefined numerical acceptance criteria or typical "device performance" values.

Instead, the "acceptance criteria" can be inferred as demonstration of comparable safety and effectiveness outcomes for Gastrectomy procedures performed with the da Vinci system when compared to laparoscopic and/or open procedures, based on literature review.

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

• Sample Size for the Test Set:
  The study is a literature review, not a primary clinical trial with a "test set" in the traditional sense of a prospectively collected cohort. The sample sizes are derived from the N values reported in the individual studies included in the meta-analysis/systematic review. For example, some studies reviewed had sample sizes for Robotic Gastrectomy ranging from 53 to 1830 patients, for Laparoscopic Gastrectomy from 61 to 4123 patients, and for Open Gastrectomy from 145 to 8585 patients.
• Data Provenance: The data provenance is stated as "Published clinical data from literature." The document extensively cites 16 publications. No specific countries of origin are mentioned, but based on typical medical literature, these would likely be international. The studies cited include:
  • Two (2) randomized controlled trials (level 1b evidence)
  • Ten (10) systematic reviews/meta-analysis (level 2a evidence)
  • Four (4) database studies (level 2c evidence)
    The nature of these studies (e.g., retrospective database analyses, prospective RCTs within the included literature) would vary.

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

This type of study does not involve "experts establishing ground truth" for individual cases in a test set. The "ground truth" here is the aggregated clinical outcomes reported in published studies, which are considered evidence-based medical conclusions. The experts involved would be the authors of the 16 published clinical studies (surgeons, statisticians, researchers, etc.) who conducted the original research and established their findings. Their specific qualifications are not detailed in this 510(k) summary, but are implicitly assumed based on the peer-reviewed nature of the published literature.

4. Adjudication Method for the Test Set

No adjudication method is applicable here as this is a review of published literature, not a study involving individual case assessments by reviewers. The "adjudication" is inherent in the peer-review process of the published articles and the methodology of systematic reviews and meta-analyses.

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 submission is for a surgical system, not an AI diagnostic/interpretive tool requiring human reader performance evaluation.

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

No standalone algorithm performance study was done. The da Vinci Xi and X Surgical Systems are electro-mechanical systems intended to assist surgeons (human-in-the-loop), not standalone algorithms. The submission explicitly states "The Intuitive Surgical Endoscopic Instrument Control System...is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments...It is intended to be used by trained physicians in an operating room environment..."

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data (e.g., mortality, EBL, LOS, complication rates, reoperation rates, etc.) collected and analyzed in previously published clinical studies (Randomized Controlled Trials, Systematic Reviews/Meta-analyses, and Database Studies).

8. The Sample Size for the Training Set

This submission does not involve a "training set" in the context of an AI/ML algorithm. The "training data" for making the determination about substantial equivalence for the new indication are the 16 published clinical studies. The sum of patients across all studies' da Vinci cohorts, laparoscopic cohorts, and open cohorts constitutes the entirety of the evidence base reviewed. These numbers are substantial, with individual studies reporting hundreds to thousands of patients (e.g., Robotic 1830, Lap 4123, Open 8585 in some studies).

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

Since there is no "training set" in the AI/ML sense, the question refers to how the evidence for the labeling modification was established. The "ground truth" (i.e., the clinical outcomes and conclusions) in the selected 16 publications was established through:

• Clinical Research Methodologies: Randomized controlled trials, systematic reviews, meta-analyses, and database studies.
• Data Collection: Gathering patient data on various clinical outcomes (e.g., EBL, LOS, complications, mortality) from surgical procedures.
• Statistical Analysis: Rigorous statistical methods applied by the authors of the original publications to analyze and interpret the collected data, leading to the reported conclusions regarding comparability or differences in outcomes between da Vinci, laparoscopic, and open surgical approaches.
• Peer Review: The scientific rigor of these publications being accepted into peer-reviewed journals.

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