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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, 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 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 procedures under the cleared "gynecologic laparoscopic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Hysterectomy (Radical, Hysterectomy for Benign Disease 1), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions. 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, electromechanical 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.

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text:

Device: da Vinci® Surgical System, Model IS4000

Acceptance Criteria and Reported Device Performance

The clinical studies for the da Vinci® Surgical System, Model IS4000, do not present a clear table of predefined numerical acceptance criteria. Instead, the studies demonstrate substantial equivalence by comparing the outcomes of da Vinci-assisted procedures to open and laparoscopic surgical procedures, focusing on comparable or superior safety and effectiveness metrics.

The reported device performance, in comparison to traditional methods (open and laparoscopic surgery), is summarized for "umbrella procedures" (Hysterectomy (Radical) Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy and Sacrocolpopexy) across various publications:

The overall acceptance is based on the demonstration that the da Vinci-assisted procedures are associated with comparable or improved outcomes (fewer complications, less blood loss, shorter hospital stays) compared to traditional methods, despite potentially longer operative times in some cases. The increased operative time was deemed acceptable as it did not lead to increased complication rates.

Study Details

The provided document describes a labeling modification for the da Vinci Xi Surgical System (Model IS4000) to include additional specific gynecologic laparoscopic surgical procedures. The performance data presented is a summary of existing pre-clinical and clinical studies that have previously been used to support the clearance of the device.

1. Sample size used for the test set and the data provenance:

   • Pre-Clinical Animal Study Data: Provided results from 7 evaluations in a total of 27 animals.
     • Provenance: Not specified, but implied to be prospective experimental data from animal studies.
   • Clinical Study Data: This refers to a review of 21 published clinical data publications. These publications included randomized controlled trials, meta-analyses, systematic reviews, Health Technology Assessments, and comparative studies.
     • Provenance: This is retrospective data analysis from various published clinical studies. The country of origin for these studies is not specified in this summary but would be diverse given the nature of published literature.

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

   • Pre-Clinical Animal Study Data: For the animal studies, the "ground truth" would be established by the researchers conducting the experiments and analyzing the physiological outcomes and histological findings. The number and qualifications of these experts are not specified in the summary.
   • Clinical Study Data: For the retrospective clinical data, the "ground truth" is derived from the reported outcomes and statistical analyses within the 21 identified publications. The experts involved would be the authors of those publications (surgeons, statisticians, researchers, etc.). The specific number and exact qualifications of these experts for all 21 publications are not provided in this summary. However, it's inherent that these would be medical professionals experienced in conducting and reporting clinical trials.

3. Adjudication method for the test set:

   • Pre-Clinical Animal Study Data: Not specified. Adjudication methods are typically outlined in the study protocols of animal research, but are not detailed here.
   • Clinical Study Data: For the aggregate of 21 publications, the adjudication method is essentially the peer-review process inherent to scientific publications. This submission itself represents an internal review and synthesis of these published findings by the manufacturer and the FDA. No specific external adjudication panel beyond this is mentioned for this particular 510(k) submission.

4. 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 device (da Vinci Surgical System) is a surgical robot that assists human surgeons, not an AI diagnostic tool that human readers interpret. The studies compare robotic assistance (human with robot) versus traditional surgery (human without robot for the specific robotic tasks). Therefore, the concept of "human readers improving with AI vs without AI assistance" in the context of interpretation accuracy doesn't directly apply. The comparison is related to surgical outcomes.

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

   • No, a standalone study was not done because the da Vinci Surgical System is designed to be a human-in-the-loop system. It is a tool that enhances a surgeon's capabilities, not an autonomous system. The indication states: "It is intended to be used by trained physicians in an operating room environment."

6. The type of ground truth used:

   • Pre-Clinical Animal Study Data: Based on anatomical observations, physiological measurements, and histopathological findings in animals.
   • Clinical Study Data: Based on clinical outcomes data from human patients, including complications (e.g., adverse events), blood transfusions, length of hospital stay, operative time, and conversion rates, as reported in published peer-reviewed medical literature. This is essentially patient outcomes data.

7. The sample size for the training set:

   • Not applicable / Not specified in this context. This 510(k) is for a labeling modification and relies on previously submitted performance data and published literature. The da Vinci Surgical System is an electro-mechanical system controlled by a surgeon, not an AI algorithm that learns from a training set in the conventional sense of machine learning. The "training" for such a system would involve engineering development, testing, and validation against design specifications and performance requirements, rather than a data-driven machine learning training set. Surgeons are also "trained" to use the system.

8. How the ground truth for the training set was established:

   • Not applicable. As explained above, for this type of medical device, the concept of a "training set" with associated "ground truth" as typically defined for AI/ML algorithms does not directly apply. The development and validation of the device rely on engineering principles, verification, and validation testing, and clinical evaluations where "ground truth" is defined by standard medical endpoints and established surgical practices.

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