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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. Itis 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. Itis 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 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 provided text describes a 510(k) submission for a labeling modification to the da Vinci Xi and X Surgical Systems, not a study to prove a device meets acceptance criteria regarding active performance metrics. The submission asserts substantial equivalence based on the current device's performance being equivalent to predicate devices for new labeled uses.

Here's an analysis of the provided information, focusing on how the request's points relate to the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds for device performance. Instead, it aims to demonstrate substantial equivalence for new labeled uses by comparing the real-world performance of the da Vinci systems (robotic-assisted, "R") with traditional laparoscopic procedures ("L") for duodenal switch bariatric surgeries. This comparison functions as the "performance" data.

Table of Device Performance (from the document, Table 1):

Acceptance Criteria Interpretation: The "acceptance criteria" here are implied by the substantial equivalence argument: the da Vinci system performance for these new indications should be comparable to or better than traditional laparoscopic methods, without raising new questions of safety or effectiveness. The p-values are used to assess statistical differences between the robotic and laparoscopic cohorts. While the robotic operative time is significantly longer (p < 0.001), some key safety outcomes (conversion to open, transfusion, intraoperative complications, and mortality) show no significant difference or favorable trends for robotic assistance (e.g., lower reoperation rate and readmission rate in the PS matched data). The submission concludes that the RWE demonstrates the safety and effectiveness of robotic-assisted duodenal switch bariatric surgical procedures and that da Vinci-assisted procedures are substantially equivalent to laparoscopic procedures based on these outcomes.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set):
  • Unmatched: 1,878 patients in total (377 robotic-assisted, 1501 laparoscopic).
  • Propensity Score Matched: 628 patients (314 robotic-assisted, 314 laparoscopic).
• Data Provenance:
  • Country of Origin: USA.
  • Nature of Data: Retrospective Real World Evidence (RWE) from the Premier Health Database (PHD). The data covers the period from 2016 to 2020.

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

The document does not describe a process of individual expert ground truth establishment for each case. Instead, the "ground truth" is derived from real-world clinical outcomes recorded in the Premier Health Database using ICD-10 and CPT codes. This implicitly relies on the medical professionals (e.g., surgeons, diagnosticians, hospital staff) who documented these codes and outcomes in clinical practice, rather than a separate panel of experts being convened to review the data for the purpose of this study.

4. Adjudication method for the test set

There is no mention of an adjudication method in the context of expert review for ground truth, as the data provenance is real-world clinical records rather than expert interpretation of medical images or other subjective assessments. The "adjudication" in this context is the inherent process of medical documentation and coding within the healthcare system.

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 study compares the outcomes of robotic-assisted surgery (where the surgeon uses the da Vinci system) versus traditional laparoscopic surgery. It is not comparing human readers' performance with and without AI assistance in reading or diagnosis. The da Vinci system is a surgical tool, not an AI diagnostic assistant. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report here.

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

No, a standalone (algorithm only) performance was not done. The da Vinci system is an "Endoscopic Instrument Control System" that "is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments." It is fundamentally a human-in-the-loop system, where the surgeon controls the robotic arms. The study evaluates the outcomes of surgery performed by surgeons with the assistance of the da Vinci system, not an autonomous algorithm.

7. The type of ground truth used

The ground truth is based on outcomes data and clinical diagnoses/procedures (documented via ICD-10 and CPT codes) from real-world patient records in the Premier Health Database. These outcomes include operative times, length of hospital stays, conversion rates, various complication rates, readmission rates, reoperation rates, and mortality rates.

8. The sample size for the training set

The document does not mention a separate "training set" in the context of an AI/machine learning model being developed or trained. This submission is for a labeling modification of an existing surgical system, not the initial clearance of a new AI algorithm. The real-world evidence presented is used to support the safety and effectiveness of the existing device for new labeled uses, but not to train a model in the typical sense.

9. How the ground truth for the training set was established

As there is no mention of a "training set" for an AI model, this question is not applicable to the provided document. The real-world data itself serves as the basis for demonstrating equivalence for the new indications, not as data for training an algorithm where ground truth needs to be established by experts.

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