(58 days)
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.
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedure of "Hepatectomy/Liver Resection" 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). 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 softwarecontrolled, 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 Surgical System (Model IS4000) and the da Vinci X Surgical System (Model IS4200) to include "Hepatectomy/Liver Resection" as a representative specific procedure under the existing Indications for Use. The submission argues for substantial equivalence based on clinical data from published literature.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define "acceptance criteria" in a quantitative manner (e.g., "mortality rate must be less than X%"). Instead, it presents a comparative effectiveness study showing that the da Vinci-assisted procedures for Hepatectomy/Liver Resection are "substantially equivalent" to minimally invasive/laparoscopic procedures based on several clinical endpoints. The acceptance criterion is implicitly that the robotic-assisted procedure's performance on these endpoints isnot worse than the comparator procedures.
The reported device performance is presented in Tables 1A and 1B: da Vinci vs. Minimally Invasive/Laparoscopic Hepatectomy/Liver Resection Procedures. These tables detail various clinical outcomes from 32 retrospective studies, 5 database studies, and 1 prospective study comparing robotic-assisted and laparoscopic/minimally invasive approaches for hepatectomy/liver resection.
Table of Performance Comparison (Derived from Tables 1A and 1B and supporting text):
| Clinical Endpoint | Acceptance Criteria (Implicit: Not worse than minimally invasive/laparoscopic results) | Reported Device Performance (da Vinci-assisted vs. Minimally Invasive/Laparoscopic) |
|---|---|---|
| Mortality Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B generally show comparable (often 0%) mortality rates for both robotic and laparoscopic groups, or small differences that are not highlighted as significant. |
| Estimated Blood Loss (EBL) Volumes | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show similar EBL ranges and means for both groups, or sometimes lower for robotic, with variations across studies. |
| Transfusion Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes lower transfusion rates for robotic, with variations across studies. |
| Lengths of Hospital Stay (LOS) | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes slightly varied LOS for both groups, with no consistent trend indicating worse outcomes for robotic. |
| Post/Peri-Operative Complication Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable complication rates for both groups, with no consistent trend indicating worse outcomes for robotic. |
| Conversion Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes lower conversion rates for robotic, with variations across studies. |
| Readmission Rates | No statistically significant increase compared to comparator. | Data in Tables 1A and 1B show comparable or sometimes lower readmission rates for robotic, with variations across studies. |
| Perforation Rates | No statistically significant increase compared to comparator. | Not explicitly detailed in the tables, but stated as an endpoint demonstrating substantial equivalence. |
| Operative Times | Acceptable, considering potential benefits or known learning curve for robotic. | Data in Tables 1A and 1B show variable operative times; in some studies robotic times are longer, in others comparable or shorter. This is often accepted for robotic procedures due to precision and benefits. |
| Biliary/Bile Leak Rates | No statistically significant increase compared to comparator. | Data in Table 1B shows comparable or low bile leak rates for both robotic and laparoscopic groups. |
| Liver Failure Rates | No statistically significant increase compared to comparator. | Data in Table 1B shows comparable or low liver failure rates for both robotic and laparoscopic groups. |
| R0 Resection Rate (Negative Margins) | No statistically significant decrease compared to comparator. | Data in Table 1B shows comparable R0 resection rates for both groups, indicating similar oncologic efficacy where applicable. |
| PSM/R1 Resection Rate (Positive Margins) | No statistically significant increase compared to comparator. | Data in Table 1B shows comparable PSM/R1 resection rates for both groups. |
2. Sample size used for the test set and the data provenance
The "test set" in this context refers to the published clinical studies analyzed.
- Sample size: The study identified 38 publications. Within these publications, individual study sizes (N) for both Robotic and Laparoscopic cohorts vary widely, as shown in Tables 1A and 1B. For example, some studies have N as low as 9 (Berber 2010 Robotic) or 10, while others are significantly larger, such as Lap 6186 (Stewart 2019) or Robotic 354 (Stewart 2019). The total number of patients across all 38 studies is not aggregated but is certainly substantial.
- Data provenance: The data is retrospective and prospective clinical data from published literature.
- One (1) prospective study (LOE 2b)
- Five (5) database studies (LOE 2c)
- Thirty-two (32) retrospective studies (LOE 3b)
The country of origin is not specified in the provided text, but it's international clinical literature.
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 outcomes reported in the individual studies (e.g., mortality, complications, EBL) would have been established by the clinical teams involved in those primary studies. This submission is a literature review, not a primary clinical study establishing new ground truth. Therefore, the "ground truth" here is derived from the aggregated findings of numerous published studies conducted by various clinical experts worldwide. The submission itself doesn't mention specific experts establishing a ground truth for its own analysis, but rather synthesizes existing expert-derived clinical data.
4. Adjudication method for the test set
Not applicable in the conventional sense. This is a review of published literature. The outcomes of the individual studies would have been adjudicated according to the methods of those respective studies. The selection of the studies for this submission was based on specific search criteria and filters as outlined in Figure A, implying a systematic review process rather than expert adjudication of individual cases for ground truth.
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. This is not an AI/imaging device. It's a surgical system where human surgeons directly control the robotic instruments. The comparative effectiveness study referenced is between human surgeons using the da Vinci system versus human surgeons using traditional minimally invasive/laparoscopic techniques. There is no mention of "human readers" or "AI assistance" in the context of improving diagnostic/interpretive tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The da Vinci system is a robotically-assisted surgical tool that requires a human surgeon in the loop. It is not an autonomous algorithm.
7. The type of ground truth used
The "ground truth" in this context is the clinical outcome data (e.g., mortality, complications, blood loss, length of stay, resection margins) reported in published peer-reviewed clinical studies. These outcomes are established through standard clinical practice, surgical records, patient follow-up, and, where applicable, pathology reports for resection margins.
8. The sample size for the training set
Not applicable. This device is a surgical system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for this device is the training of surgeons to use the system, which is mentioned in the Indications for Use: "It is intended to be used by trained physicians."
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set" in the context of an AI algorithm. The training of surgeons involves established surgical curricula, proctoring, and credentialing processes within medical institutions, based on clinical experience and outcomes.
§ 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.