(96 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 endloscopic 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 laparossopic 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 pediatic 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 da Vinci Xi Surgical System, Model IS4000, is a softwarecontrolled, 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.
It appears that the provided text is a 510(k) summary for a medical device (da Vinci Xi Surgical System) and focuses on a labeling modification rather than presenting a performance study of the device itself against specific acceptance criteria for a new algorithmic feature. The submission is to include "Inguinal Hernia Repair" procedures under an already cleared "general laparoscopic surgical procedures" indication.
Therefore, the information I can extract to directly answer your request about device acceptance criteria and a study proving it meets them for a specific performance metric (like algorithm accuracy) is limited, as this is primarily a procedural and comparative effectiveness submission for a surgical procedure, not an AI algorithm.
However, I can reframe the "acceptance criteria" based on the comparative effectiveness study presented for the procedure performed with the device. The study aims to demonstrate that robotic-assisted inguinal hernia repair is "safe and effective" and compares several clinical outcomes to open surgery and laparoscopic procedures.
Here's the closest I can get to your request based on the provided document:
Acceptance Criteria and Study for da Vinci Xi Surgical System (for Inguinal Hernia Repair Procedure Labeling)
The acceptance criteria are not explicitly stated in terms of a quantifiable threshold for a device's performance (e.g., AUC > 0.90 for an AI algorithm). Instead, the study aims to demonstrate that performing Inguinal Hernia Repair with the da Vinci Xi Surgical System is safe and effective and comparable or superior in key clinical outcomes to existing standard-of-care procedures (open and traditional laparoscopic surgery).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit for Procedure) | Reported Device Performance (Robotic-Assisted vs. Open/Laparoscopic) |
|---|---|
| Safety: | |
| Intraoperative Complications (comparable to open) | Comparable (0.3% robotic-assisted vs. 0% open; within 0-8% for laparoscopic) |
| Transfusions (comparable to open) | Comparable (0.3% perioperative robotic-assisted vs. 0.3% perioperative open; intraoperative 0% for both) |
| Postoperative Complications (Discharge through 30 days) (comparable/better) | Lower rate (4.3% robotic-assisted vs. 7.3% open); propensity-matched analysis also showed robotic-assisted associated with lower likelihood of complications. |
| Readmission Rates (comparable to open) | Comparable (3.5% robotic-assisted vs. 4.3% open) |
| Reoperation Rates (Postoperative to Discharge) (comparable to open) | Comparable (0.5% robotic-assisted vs. 0.3% open; within 0-2.5% for laparoscopic) |
| Reoperation Rates (Discharge through 30 days) (comparable/better) | Lower rate (0% robotic-assisted vs. 1.3% open); however, propensity-matched analysis showed comparable rates. |
| Mortality (comparable to open) | Comparable (0% robotic-assisted vs. 1 open) |
| All Complications (comparable to open/laparoscopic) | Comparable (6.9% robotic-assisted vs. 8.5% open; within 7.9-8.7% for laparoscopic) |
| Effectiveness: | |
| Length of Stay (comparable to open/laparoscopic) | Comparable outpatient; for inpatient, comparable, but propensity-matched analysis showed statistically lower inpatient length of stay for robotic-assisted. |
| Operative Time (explicitly acknowledged as longer but without adverse impact) | Longer (79.7 ± 31.7 min robotic-assisted vs. 45.0 ± 21.7 min open); however, this longer time was "not associated with increases in the complication, readmission, reoperation or mortality rates." (This implies an "acceptable" longer operative time if other outcomes are preserved or improved). |
| Conversion Rate (for robotic-assisted to open) | 0.9% (reported for robotic-assisted, no comparable data for other cohorts directly in table format) |
| Absence of adverse events (death or serious injury) | 44 adverse events reported for robotic-assisted, 49 for open, with a higher concentration at one site for both. The study defines this as serious injury (Clavien Grade IIIa or higher). |
2. Sample Size and Data Provenance
-
Test Set (Clinical Study Data):
- Robotic-assisted cohort: 652 subjects
- Open cohort: 602 subjects
- Laparoscopic cohort: Variable
Nfrom 20 to 3,457 (derived from 11 published studies for comparison) - Data Provenance: Retrospective, multi-center, non-randomized controlled clinical study conducted at six (6) investigational sites in the United States. The laparoscopic comparison data is from published literature (Bittner, et al., 2015).
-
Training Set: Not applicable as this is not a machine learning model being trained and tested. This is a post-market clinical study for a labeling modification of an existing surgical system.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- The "ground truth" for the clinical study is the actual clinical outcomes observed in patients undergoing the procedures (e.g., actual complications, readmissions, reoperations, length of stay, mortality). These are objective clinical endpoints, not subjective interpretations by experts. Therefore, the concept of "experts establishing ground truth" as it applies to an image interpretation AI model does not fit here. The study involved practicing surgeons and medical staff at the investigational sites who collected the data.
4. Adjudication Method for the Test Set
- The document does not describe a formal "adjudication method" for the clinical endpoints in the same way one would for an AI model's output. Clinical data collection would typically follow standard protocols at each investigational site, potentially with source data verification, but not an "adjudication" of the data itself by independent experts in the context of resolving disagreements on results. The data are quantitative clinical outcomes.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not done. This study is a clinical comparative effectiveness study comparing surgical approaches (robotic-assisted vs. open vs. laparoscopic) for a specific procedure. It does not involve multiple human readers interpreting images with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone study was not done. The da Vinci Xi Surgical System is a surgical robotic system with human-in-the-loop (the surgeon). The study evaluates the performance of the procedure when performed with this system, not an isolated algorithm. The submission is for a labeling modification to include a new procedure, not a new algorithm or AI functionality.
7. Type of Ground Truth Used
- The ground truth used for the clinical study was clinical outcomes data collected from patient records (e.g., hospital discharge records, patient follow-ups). These include objective metrics like length of stay, occurrence of complications, reoperations, readmissions, and mortality.
8. Sample Size for the Training Set
- Not applicable; see point 2.
9. How the Ground Truth for the Training Set Was Established
- Not applicable; see point 2.
Summary for this specific 510(k) context:
This 510(k) is about expanding the indications for use of an existing surgical robotic system to include Inguinal Hernia Repair. The "study" here is a clinical comparative effectiveness study demonstrating that the procedure performed with the device is safe and effective and compares favorably or acceptably to existing surgical methods. It is not an AI/algorithm performance study on a test set, so many of the requested items (like expert ground truth for interpretation, MRMC, standalone algorithm performance, or specific AI training/test set details) are not directly addressed in the provided text.
§ 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.