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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.

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.

This 510(k) is for a labeling modification only, to include the following additional representative, specific foregut procedures under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication and Toupet Fundoplication. 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 software-controlled, 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 document describes a 510(k) premarket notification for a labeling modification to the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200). The modification seeks to include additional "foregut" procedures (Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication, and Toupet Fundoplication) under the already cleared "general laparoscopic surgical procedures" Indications for Use. The submission states that there are no changes to the technological characteristics of the device, implying that the device itself is not being changed, only its listed indications for use. Therefore, standard acceptance criteria for device performance (e.g., accuracy, precision, safety) in a new or modified device submission are not applicable here in the typical sense. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence for the expanded indications.

The study that proves the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence for the new indications) is a clinical literature review comparing the da Vinci-assisted procedures to minimally invasive/laparoscopic procedures for the "foregut" procedures.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a labeling modification only, with no technological changes to the device, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence for the expanded indications through clinical outcomes. The device performance is reported by comparing outcomes of da Vinci-assisted procedures to standard minimally invasive/laparoscopic procedures.

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

• Sample Size (Test Set): The sample sizes vary by study within the literature review. For Heller Myotomy, the combined robotic cases across the 8 studies in Table 1A total 1043 patients. The combined laparoscopic cases total 5787 patients. For Hiatal/Paraesophageal/Sliding Hernia Repair, the combined robotic cases across the 7 studies in Table 1B total 1878 patients. The combined laparoscopic cases total 7085 patients.
• Data Provenance: The data provenance is from published clinical literature. The document states that "Fifteen (15) publications were identified...used in three (3) databases: PubMed, Scopus and Embase." These studies would encompass various countries and healthcare systems depending on the authors' affiliations. The study types include two (2) systematic reviews/meta-analyses, one (1) prospective study, two (2) database studies, and ten (10) retrospective studies.

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

The ground truth for the test set (the clinical outcomes reported in the literature) was established by the physicians and researchers who conducted the original studies. The document does not specify the number or specific qualifications of these original researchers, but it can be inferred that they are medical professionals and researchers in the field of surgery, as their work was published in peer-reviewed journals and structured as systematic reviews, prospective, database, and retrospective studies.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set in the context of the 510(k) submission. Instead, the "adjudication" of the clinical data comes from:

• The peer-review process of the scientific journals where the original 15 papers were published.
• The methodology of systematic reviews and meta-analyses included, which involve rigorous evaluation of study quality and results.
• The FDA's own review of these publications to determine if they support substantial equivalence.

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. An MRMC comparative effectiveness study was not done. This submission is for a surgical system and its indications, not an AI-powered diagnostic or interpretive tool that would typically involve human "readers" or AI assistance in interpretation. The comparison is between different surgical approaches (da Vinci-assisted vs. conventional laparoscopic), not between human performance with and without AI.

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

Given that the device is a surgical system (the da Vinci Xi and X Surgical Systems), which involves a human surgeon operating the robot, a "standalone algorithm only" performance study is not applicable or relevant to this device. This device is inherently "human-in-the-loop."

7. The Type of Ground Truth Used

The ground truth used is clinical outcomes data reported in published medical literature. These outcomes include objective measures such as mortality rates, estimated blood loss, length of hospital stay, complication rates (intraoperative and postoperative), conversion rates, readmission rates, perforation rates, reoperation rates, and operative times. This data is the direct result of actual surgical procedures.

8. The Sample Size for the Training Set

Not applicable. The submission describes a labeling modification for an existing surgical system. As there are no changes to the technological characteristics of the device and no new algorithm is being deployed, there is no "training set" in the context of machine learning or AI algorithms. The system's "training" for surgeons occurs through professional instruction and practice, not through a data-driven training set in the AI sense.

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

Not applicable, as there is no training set in the AI/ML context. If interpreted metaphorically, the "ground truth" for training surgeons on how to use the da Vinci system is established through medical education, surgical training programs, professional instructions for use, and clinical experience, guided by established surgical best practices and outcomes. However, this is not a ground truth for a machine learning training set as typically inquired.

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