(268 days)
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 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 procedures under the cleared "urologic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical, Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy. 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, electro-mechanical 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.
The provided text describes a 510(k) submission for a labeling modification to the da Vinci Xi Surgical System, Model IS4000 (K161178), to include additional urologic surgical procedures. This is not a study that establishes acceptance criteria for a new device's performance, but rather a submission seeking to expand the indications for use of an already cleared device based on existing clinical literature.
Therefore, the sections related to acceptance criteria, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for a novel AI/device performance study are not applicable in the context of this document. This document focuses on demonstrating substantial equivalence to predicate devices using existing performance data (published clinical studies and prior animal studies).
However, I can extract and organize the information that is present in the document which relates to performance data and the comparison of the da Vinci Xi Surgical System to other surgical methods for the "umbrella" procedures.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a labeling modification, there are no explicit "acceptance criteria" defined in the typical sense of a de novo device performance study with specific metrics and thresholds. Instead, the document demonstrates "substantial equivalence" based on various clinical outcomes from published literature comparing the da Vinci system to open and laparoscopic procedures. The reported performance is a summary of these extensive literature reviews for the "umbrella procedures."
Below is a summary table compiled from the provided text, focusing on key clinical outcomes for the "umbrella procedures" (Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical)) as compared to open and laparoscopic surgical procedures. The data are presented comparatively rather than as meeting specific numerical acceptance thresholds.
| Outcome Measure | Da Vinci-assisted Procedures (Compared to Open/Laparoscopic) |
|---|---|
| For Prostatectomy (Radical): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower |
| EBL Volumes | Comparable or Lower |
| Length of Hospital Stay | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable or Lower (one report higher vs. open) |
| Postoperative Complication Rates | Comparable or Lower (one report higher vs. laparoscopic) |
| Positive Surgical Margins | Comparable Rates (one report higher vs. laparoscopic but similar overall) |
| Potency and Continence Rates | Comparable or Higher |
| Operative Times | Comparable or Shorter (several noted increased vs. open but without increased mortality/complications) |
| Conversion Rates | Comparable or Lower (vs. laparoscopic) |
| For Nephrectomy (Partial): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower |
| EBL Volumes | Comparable or Lower |
| Length of Hospital Stay | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable or Lower |
| Postoperative Complication Rates | Comparable or Lower |
| Positive Surgical Margins | Comparable Rates |
| Warm Ischemia Times | Comparable or Shorter (two noted higher vs. open but within safe limits) |
| Operative Times | Comparable or Shorter (several noted increased vs. open but without increased mortality/complications) |
| Conversion Rates | Comparable or Lower (vs. laparoscopic) |
| For Nephrectomy (Radical): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower (one report higher vs. open/lap) |
| EBL Volumes | Comparable |
| Length of Hospital Stay | Comparable or Shorter (one report longer vs. lap) |
| Intraoperative Complication Rates | Comparable or Lower |
| Postoperative Complication Rates | Comparable or Lower (one report higher vs. lap) |
| Operative Times | Comparable or Shorter (comparable vs. laparoscopic) |
| Conversion Rates | Comparable (vs. laparoscopic) |
| For Cystectomy (Radical): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower |
| EBL Volumes | Comparable or Lower |
| Length of Hospital Stay | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable or Lower |
| Postoperative Complication Rates | Comparable or Lower (one report higher 90-day rate vs. open, but lower mortality) |
| Positive Surgical Margins | Comparable Rates |
| Operative Times | Comparable (several noted increased vs. open/lap but without increased mortality/complications) |
| Conversion Rates | Reported but not explicitly compared |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: This submission relies on data from multiple published clinical studies comparing the da Vinci system to predicate surgical techniques. The "test set" is, therefore, the aggregate of patients included in these published studies. For the "umbrella procedures" (Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical)), 61 publications were identified. The tables (TABLE 1, TABLE 2, TABLE 3, TABLE 4) show a wide range of sample sizes for individual studies, ranging from as low as 13 patients (e.g., Boger (2010), da Vinci arm for Nephrectomy (Radical)) to as high as 167,184 patients (e.g., Tewari (2012), Open arm for Prostatectomy (Radical)). The total number of unique patients across all 61 studies is not aggregated in this document, but it represents a substantial number.
- Data Provenance: The data is retrospective and prospective, originating from published clinical literature. The countries of origin are not specified, but the use of meta-analyses and large database studies implies a broad geographical range. The studies are categorized as:
- Prospective randomized controlled trials
- Meta-analyses
- Systematic reviews
- Health Technology Assessments (HTAs)
- Large database studies
- Comparative studies
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for the performance data comes from published clinical outcomes, which are established by the medical community and researchers who conducted the original studies. The FDA review process itself involves experts (e.g., medical officers and scientific reviewers) who critically evaluate the submitted data, but they are not establishing ground truth for the device's performance in the same way an expert panel would adjudicate images for an AI algorithm.
4. Adjudication Method for the Test Set:
- Not applicable in the context of this 510(k) submission, as it relies on literature review for clinical outcomes rather than a specific test set requiring adjudication in the context of a de novo performance study. The publications chosen based on "specific search criteria and filters" underwent a form of selection and review by Intuitive Surgical, Inc. and subsequently by the FDA.
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:
- Not applicable. This is not an AI-assisted diagnostic device where "human readers improve with AI." The da Vinci Xi Surgical System is a surgical robot intended to assist surgeons in performing minimally invasive surgery. The comparison is between different surgical techniques (robot-assisted vs. open vs. laparoscopic), not human diagnostic performance with and without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The da Vinci system is inherently a "human-in-the-loop" device, requiring a trained physician to operate it. It does not perform any task standalone in the medical context discussed.
7. The Type of Ground Truth Used:
- The "ground truth" is based on clinical outcomes data reported in peer-reviewed medical publications. This includes metrics like mortality rates, blood transfusion rates, length of hospital stay, intraoperative and postoperative complication rates, positive surgical margins, potency and continence rates, warm ischemia times, and operative times.
8. The Sample Size for the Training Set:
- Not applicable. This document describes a literature review for expanding indications of an already cleared device, not an AI algorithm development where a specific "training set" of data would be used to train the algorithm. The device itself (the da Vinci Xi Surgical System) was developed and refined through engineering, pre-clinical testing, and extensive clinical experience prior to its initial clearance and prior to this labeling modification. Pre-clinical animal study data were provided in the original submissions for the da Vinci Xi Surgical System (K131861, K140189, K152241, K152578, and K153276), which included results from eight (8) evaluations in a total of 31 animals for various procedures. These animal data serve as part of the developmental and validation process for the system's design but do not constitute a "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" in the AI sense for this 510(k) submission. The animal study outcomes were established through direct observation and measurement in the animal models.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.