(277 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, scissors, 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 da Vinci 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 surgeon seated at the Surgeon Console controls all movement of the EndoWrist Instruments and Endoscope by using two Master Controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a High Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features. The VSC includes the supporting electronic and video processing equipment for the system. The PSC is positioned at the operating room table and has four endoscope/instrument arms that are positioned over the target patient anatomy. An endoscope attaches onto one arm and provides the surgeon a high resolution, three-dimensional view of the patient anatomy. A suite of EndoWrist Instruments are attached/detached from the arms, enabling the surgeon to perform various surgical tasks. Accessories such as cannulas, obturators, seals, and drapes are also needed to perform procedures with the system.
Here's a breakdown of the acceptance criteria and the studies that support the performance of the Intuitive Surgical da Vinci Surgical System, Model IS4000, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary doesn't present a single, consolidated table of specific quantitative acceptance criteria with corresponding performance metrics like a typical clinical trial. Instead, the "acceptance criteria" are embedded within the descriptions of various verification and validation studies as "objective pass/fail criteria," "success criteria," and "ability to perform procedure safely and effectively." The Reported Device Performance generally indicates that these criteria were met.
Due to the nature of the primary evidence presented (bench testing, animal/cadaver models, and human factors assessment for substantial equivalence to a predicate device), the "performance metrics" are largely qualitative affirmations of functionality, safety, and clinical utility.
| Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|
| Bench Verification: | |
| Physical, mechanical, electrical, and system level requirements and design specifications met for PSC sub-components. | Tests verified that requirements and specifications were met. |
| VSC sub-components met functional requirements as defined in Functional Specification Documents. | Tests verified that functional requirements were met. |
| IS4000 instruments met physical, mechanical, and electrical requirements and specifications; compatible with software parameters and user interface. | Tests verified that requirements and specifications were met for all instrument types, including electrical testing, load handling, and grip force comparison. |
| Reusable instruments met projected life (5 clinical uses) after life testing (8 life cycles). | Confirmed that 9 representative instrument types met projected life. |
| Drapes with sterile adapters maintained sterility. | Evaluations confirmed drapes met specifications and requirements for maintenance of sterility. |
| Reusable trocars met physical, mechanical, and interface requirements. | Tests confirmed trocars met requirements. |
| Pre-Clinical Verification (Cadaver & Animal Models): | |
| Ability of IS4000 system to safely and effectively: maneuver PSC and USMs, reach/attach USMs, maintain adequate external clearance, reach internal surgical targets, maximize patient access. | The IS4000 system demonstrated the ability to safely and effectively perform all listed actions across various procedures (Low Anterior Resection, Gastric Bypass, Hysterectomy, Mitral Valve Repair, Cardiac Revascularization, Nephrectomy, Pediatric) in cadaver and porcine models. |
| Representative Surgical Procedures in Live Animal Models - Safety: Ability to perform procedure without intraoperative adverse events; normal vital signs & absence of device-related adverse events post-op. | Right Colectomy (Canine): Procedure performed without intraoperative adverse events (except for one non-device-related splenic injury during port placement, repaired). All animals survived 26 days with normal vital signs and no device-related adverse events. |
| Nissen Fundoplication (Canine): Procedure performed without intraoperative adverse events (except for one non-device-related splenic injury, controlled). All animals survived with normal vital signs and no device-related adverse events. | |
| Pyeloplasty (Porcine): Procedure performed without intraoperative adverse events. All animals survived 26 days with normal vital signs and no device-related adverse events. | |
| Radical Nephrectomy (Porcine): Procedure performed without intraoperative adverse events (except for one non-device-related splenic injury during port placement, controlled). All animals survived 25-28 days with normal vital signs and no device-related adverse events. | |
| Hysterectomy (Porcine): Procedure performed without intraoperative adverse events. All animals survived 21 days with normal vital signs and no device-related adverse events. | |
| Mitral Valve Repair (Canine): Procedure performed without intraoperative adverse events (except for one non-device-related death in IS4000 group, excluded and replaced). No device-related adverse events. | |
| Representative Surgical Procedures in Live Animal Models - Effectiveness: Specific clinical endpoints appropriate for each procedure. | Right Colectomy (Canine): Ileocolic anastomosis intact and healthy at euthanasia day. Normal eating and bowel movements post-op. Findings: Surgical time 30-65 min (shorter with experience), no conversion to open, EBL 10ml, anastomoses intact and functional for all 4 animals. |
| Nissen Fundoplication (Canine): Fundoplication wrap intact and healthy at euthanasia day. Normal eating post-op. Findings: Surgical time 48-68 min, no conversion to open, EBL 13.8ml average, all wraps intact and no abnormalities. | |
| Pyeloplasty (Porcine): Normal urine passage, normal ureter peristalsis & no stricture at euthanasia. Normal eating/bowel movements post-op. Findings: Surgical time 50-62 min, no conversion to open, EBL 15ml average, ureteral anastomoses intact/functional, no stricture. | |
| Radical Nephrectomy (Porcine): Successful organ removal. Normal eating/bowel movements post-op. Findings: Surgical time 35-42 min, no conversion to open, EBL 12.5ml average, successful kidney removal for all 4 animals. | |
| Hysterectomy (Porcine): Successful organ removal. Normal eating/bowel movements post-op. Findings: Surgical time 29-55 min (shorter with experience), no conversion to open, EBL 10ml average, successful uterus removal for all 4 animals, vaginal cuffs intact, no leaks. | |
| Mitral Valve Repair (Canine): Cardioplegia catheter placement, pacemaker lead simulation, leaflet defect closure, annuloplasty with flexible band, intra-operative valve leak test. Findings: Surgical times comparable between IS3000 and IS4000 for various steps. All animals had mitral valve regurgitation measures equal to pre-op measures, acceptable to surgeons. | |
| Human Factors: Intended users could perform essential and high-risk tasks safely and effectively; use-related risks mitigated; overall ease of use/usability assessed; no previously unknown use-related risks introduced. | Found to be safe and effective for its intended uses, by intended users, in intended environment. Use-related risks identified and mitigated, ensuring residual risk at acceptable levels and no diminished use-safety compared to IS3000. |
2. Sample Sizes and Data Provenance
-
Test Set (Verification/Validation Studies):
- Bench Verification:
- PSC: 1 to 6 units (depending on test case).
- VSC: 1 unit (except Endoscope and Endoscope adapter: 4-5 units).
- Instruments: Up to 5 units for all 24 instruments (specific numbers for load handling/grip forces not given, but mentioned "worst case representative instruments").
- Instrument Reliability/Life Testing: 9 instrument types, 4 units each.
- Accessories Testing: 5 units of each drape type; 4 units of each reusable trocar type.
- Pre-Clinical Verification (Cadaver and Animal Models):
- 10 human cadavers (2 male, 8 female).
- One 20 kg porcine model.
- Representative Surgical Procedures in Live Animal Models:
- Right Colectomy (Canine): N=4
- Nissen Fundoplication (Canine): N=4
- Pyeloplasty (Porcine): N=4
- Radical Nephrectomy (Porcine): N=4
- Hysterectomy (Porcine): N=4
- Mitral Valve Repair (Canine): N=9 (one IS4000 animal excluded due to non-device related death, replaced by another)
- Human Factors:
- 15 teams of users (includes 15 surgeons and 15 OR staff: 5 circulating nurses, 9 scrub nurse/tech, 1 physician's assistant).
- Bench Verification:
-
Data Provenance: The document does not specify the country of origin for the cadaver or animal models. The human factors study involved US-based participants (surgeons and OR staff) in a simulated OR environment. All studies appear to be prospective verification and validation studies designed specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- Bench Verification: "Objective pass/fail criteria are defined and used." No specific number of experts mentioned, implies internal engineering/design team.
- Pre-Clinical Verification (Cadaver and Animal Models): No specific experts were used to "establish ground truth" in the diagnostic sense, rather, the performance was observed and evaluated against predefined functional/access requirements by the study team.
- Representative Surgical Procedures in Live Animal Models:
- One investigator (surgeon) for Right Colectomy, Nissen Fundoplication, Pyeloplasty, Radical Nephrectomy, Hysterectomy studies.
- Two board-certified cardio-thoracic surgeons for Mitral Valve Repair.
- Veterinary Pathologist for histopathology "if needed on abnormal tissue" for postmortem assessment (impartial expert for specific findings).
- Human Factors:
- 15 surgeons from different specialties (urology, gynecology, general surgery, thoracic) with varied experience from novice (200 cases).
- 15 OR staff (5 circulating nurses, 9 scrub nurse/tech, 1 physician's assistant).
- These participants serve as the "ground truth" for usability and human factors, as their ability to safely and effectively use the device is what's being evaluated. Their qualifications are stated as their professional roles and experience levels.
4. Adjudication Method for the Test Set
- Bench Verification: "Objective pass/fail criteria are defined and used." This implies a clear binary assessment against predetermined standards, likely without subjective adjudication.
- Pre-Clinical Verification (Cadaver and Animal Models): Not explicitly stated, but the "safely and effectively" assessment likely involved the study investigators/team evaluating against pre-defined success metrics.
- Representative Surgical Procedures in Live Animal Models:
- For safety (adverse events) and effectiveness (clinical endpoints), the investigator(s) performing the surgery and the veterinary pathologist for postmortem assessment made the determinations. The presence of a single investigator for most studies suggests a direct observation without explicit multi-reader adjudication committees.
- In the Mitral Valve Repair study, with two surgeons performing the procedures, there's no mention of a formal adjudication process beyond their individual assessments within the study protocol.
- Human Factors: "Objective performance data included observations of users' ability to complete tasks, use-errors, close calls, and any difficulties encountered." "Subjective feedback included open-ended questions about risks and safety, multiple choice ratings, and follow-up interviews." This suggests data collection by human factors specialists who then analyze the findings, rather than an adjudication method typically seen in diagnostic accuracy studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly conducted to assess human reader improvement with AI vs. without AI assistance.
- The only comparative study mentioned is the "Mitral Valve Repair" study in canine models, which compared the performance of the IS4000 system to the predicate IS3000 system, using two surgeons for each model. This was a direct comparison of the devices themselves, not an assessment of human reader performance with or without AI assistance. The da Vinci system is not an AI-assisted diagnostic tool; it is a surgical robotics platform. Thus, the concept of "improving human readers with AI" is not directly applicable to this device's function.
6. Standalone (Algorithm Only) Performance
- Not applicable. The da Vinci Surgical System is an electro-mechanical system with a human surgeon in the loop at all times, controlling the instruments. It does not operate as a standalone algorithm without human interaction. Its "performance" is inherently tied to the interaction between the surgeon and the machine.
7. Type of Ground Truth Used
The "ground truth" for the performance of the da Vinci Surgical System, Model IS4000, is established through a combination of:
- Engineering Specifications and Bench Test Results: For physical, mechanical, and electrical properties, and instrument durability.
- Functional Success in Cadaveric and Live Animal Models: The ability to achieve surgical access, reach targets, maintain clearance, and successfully complete representative surgical procedures (e.g., intact anastomoses, successful organ removal, absence of stricture). This is based on direct observation and postmortem assessment by surgical investigators and veterinary pathologists.
- Human Factors Assessment: Demonstrating that intended users can perform tasks safely and effectively, with identified use-related risks mitigated, as assessed through observation and feedback from surgeons and OR staff.
- Substantial Equivalence: The ultimate ground truth for regulatory approval here is demonstrating substantial equivalence to the predicate device (IS3000), meaning the new device is as safe and effective as the already marketed predicate.
8. Sample Size for the Training Set
- The document describes verification and validation for a new surgical system, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The device's "training" in a functional sense comes through its design, engineering, and iterative development processes, not through data input in the same way an AI model is trained.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" for an AI/ML algorithm is not applicable here, this question is not relevant to the information provided about the da Vinci Surgical System.
§ 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.