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510(k) Data Aggregation
(511 days)
da Vinci X and Xi Surgical System
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" and "general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indications 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: Esophagectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS400) 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 provided document is a 510(k) summary for the da Vinci Xi and X Surgical Systems, related to a labeling modification to include Esophagectomy as a labeled use. This document is a regulatory submission to the FDA, not a study report, and therefore it does not detail specific acceptance criteria or an internal study designed to prove the device meets those criteria in the traditional academic sense. Instead, it presents a summary of existing published clinical data to demonstrate "substantial equivalence" to a predicate device for the new labeled use.
Here's an analysis based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify formal "acceptance criteria" in terms of specific performance thresholds that the device itself must meet in an experimental setting for the new indication. Instead, the study aims to show that the performance of the da Vinci system for esophagectomy procedures, as reported in published literature, is substantially equivalent to established minimally invasive, laparoscopic, and/or video-assisted esophagectomy (MIE) procedures.
The reported performance is summarized across various clinical endpoints. For the purpose of this analysis, I will present the reported performance of the da Vinci group compared to the MIE group for key endpoints, noting that performance varies across the 17 publications. The acceptance is implicitly that the outcomes are comparable or non-inferior to MIE.
| Acceptance Criteria (Implied: Non-inferiority to MIE) | Reported Device Performance (da Vinci vs. MIE - range across studies) |
|---|---|
| Mortality Rates (in-hospital - 30 days) | da Vinci: 0% - 8.8% |
| MIE: 0% - 17.6% | |
| (Several studies showed 0% for both, or comparable rates, some robotic were higher) | |
| Estimated Blood Loss (EBL) Volumes (ml) | da Vinci: 83.33 - 492 |
| MIE: 120.75 - 466.8 | |
| (Generally comparable, sometimes lower, sometimes higher for robotic) | |
| Blood Transfusion Rates (%) | da Vinci: 0% - 15.4% |
| MIE: 0% - 9.76% | |
| (Mixed, some Robotic higher, some lower) | |
| Lengths of Hospital Stay (LOS) (days) | da Vinci: 8.7 - 22 |
| MIE: 9.8 - 35.5 | |
| (Often comparable or shorter for robotic) | |
| Intraoperative Complication Rates (%) | Not consistently reported for both, but implicitly comparable where mentioned. |
| Postoperative Complication Rates (%) | da Vinci: 0% - 45% |
| MIE: 0% - 64.71% | |
| (Generally comparable, sometimes lower for robotic) | |
| Conversion Rates (%) | da Vinci: 0% - 11% |
| MIE: 0% - 12.7% | |
| (Generally comparable, often lower for robotic) | |
| Reoperation Rates (%) | da Vinci: 0% - 17% |
| MIE: 0% - 17.6% | |
| (Generally comparable) | |
| Readmission Rates (%) | da Vinci: 10.3% - 18% |
| MIE: 11.7% - 18% | |
| (Generally comparable) | |
| Anastomotic Leak Rates (ALR) (%) | da Vinci: 2.8% - 37.5% |
| MIE: 2.3% - 29.4% | |
| (Mixed, often comparable, specific subgroup analysis mentioned handsewn robotic 14.73% vs stapled robotic 9.24%) | |
| Operative Times (minutes) | da Vinci: 149.33 - 692.5 |
| MIE: 156.05 - 649.5 | |
| (Mixed, some robotic longer, some shorter) | |
| Positive Surgical Margin Rate (%) | da Vinci: 0% - 12.5% |
| MIE: 0% - 10.0% | |
| (Generally comparable, often 0% for both) | |
| R0 Resection Rate (%) (Complete resection with clear margins) | da Vinci: 94.1% - 100% |
| MIE: 60% - 100% | |
| (Generally high and comparable, some Robotic higher) | |
| Lymph Node Yield (n) | da Vinci: 14.28 - 52 |
| MIE: 9 - 59 | |
| (Generally comparable, some Robotic higher or lower) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The "test set" for the substantial equivalence demonstration consists of data extracted from 17 published clinical studies (one prospective, five database studies, and eleven retrospective studies). The sample sizes within these individual studies vary widely, from as low as 11 Robotic patients in Weksler 2012 to as high as 569 Robotic patients in Weksler 2017 and 625 MIE patients in Harbison 2019. The total number of patients across all included studies is not explicitly summed, but it represents a substantial aggregate.
- Data Provenance: The studies are published clinical data, implying various international and national origins, and varying institutional settings. The document itself does not specify the countries of origin for each study. The studies include both retrospective (11 studies) and prospective (1 study) designs, along with database studies (5 studies).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not describe a process for establishing ground truth by a panel of experts for a specific test set. This is because it is a literature review, not a de novo clinical trial. The "ground truth" for the performance metrics (e.g., mortality, complications) is implicitly the aggregated and reported outcomes from the published clinical studies themselves, which are collected and analyzed by the authors of those studies based on their clinical data. The clinicians carrying out the procedures and collecting the data in the original publications would be the "experts" in this context. Their qualifications are not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set:
No specific adjudication method for the "test set" (i.e., the reviewed literature) is described. The 510(k) summary extracts and presents data from published studies. Any internal adjudication of data within those original studies would have been performed by the authors of those publications. The 510(k) summary itself performed a search, inclusion/exclusion criteria, and summary of the findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The da Vinci system is a surgical instrument control system, not a diagnostic imaging device.
6. Standalone Performance (Algorithm Only):
The da Vinci system is a surgical instrument control system that assists human surgeons; it is not an autonomous artificial intelligence algorithm. Thus, the concept of "standalone performance" (algorithm only without human-in-the-loop) does not apply in the context describe by the 510(k) in the usual sense for AI/ML enabled devices. Its performance is always in conjunction with a human surgeon. The current submission is a labeling modification, specifically for expanding the indications for use.
7. Type of Ground Truth Used:
The "ground truth" for evaluating substantial equivalence in this submission is clinical outcomes data reported in peer-reviewed medical literature. These outcomes include mortality rates, complication rates, blood loss, length of hospital stay, and pathological findings (e.g., positive surgical margin rates, lymph node yield).
8. Sample Size for the Training Set:
The document describes a literature review to support a labeling change, not an AI/ML algorithm development. Therefore, there is no "training set" in the context of machine learning model development. The 17 publications used for presenting clinical data could be considered the "dataset" for demonstrating substantial equivalence for the new indication.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/ML algorithm described, this question is not applicable. The data in the 17 publications would have had their own "ground truth" established within each original study through clinical chart review, pathology reports, surgeon intraoperative notes, and direct patient follow-up.
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