(294 days)
To assist in the accurate control of endoscopic instruments in minimally invasive surgery.
da Vincio SpTM Surgical System, Model SP999: The Intuitive Surgical Endoscopic Instrument Control System (da Vincio Sp™ Surgical System, Model SP999) is intended to assist in the accurate control of Intuitive Surgical EndoWrist® Sp™ Instruments during urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
EndoWrist® Sp™ Instruments: Intuitive Surgical EndoWrist® Sp™ Instruments are controlled by the da Vincio Sp™ Surgical System, Model SP999, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single incision laparoscopic approach. The system is indicated for urologic surgical procedures that are appropriate for a single port approach. The system is indicated for adult use. It is intended for use 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 Sp Surgical System. Model SP999 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model SP999 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with a Camera Instrument, EndoWrist Sp Instruments, and Accessories.
Acceptance Criteria and Device Performance Study for da Vinci® Sp™ Surgical System, Model SP999
The provided 510(k) summary outlines the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the da Vinci® Sp™ Surgical System, Model SP999, to its predicate devices. The studies primarily focused on mechanical, electrical, and functional verification, safety, and simulated use in animal and cadaver models.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were established qualitatively through various tests to ensure the new device performed equivalently or acceptably compared to the predicate device. The performance was assessed based on the successful completion of surgical tasks and overall system functionality.
| Acceptance Criteria Category | Specific Criteria (Implicitly) | Reported Device Performance |
|---|---|---|
| Bench Verifications | - Brake forces within specified limits | Patient Cart, Instrument Arm, and Instrument Drives subjected to full design verification to mechanical/electrical specifications. |
| - Safety requirements met | Safety verified for Patient Cart, Instrument Arm/EGM, and Instrument Drives. Electrical and Patient safety verified for Camera and Surgical Instruments. | |
| - Lower-risk mechanical requirements met | Patient Cart confirmed for lower-risk mechanical requirements. | |
| - Miscellaneous design features verified | Patient Cart confirmed for miscellaneous design features. | |
| - External testing requirements met | Patient Cart confirmed for external testing. | |
| - Applied loads within limits | Instrument Arm/EGM confirmed for applied loads. | |
| - Interfaces met specifications | Instrument Arm/EGM confirmed for interfaces. Equipment interfaces for Camera and Surgical Instruments verified. | |
| - Mechanical design specifications met | Instrument Arm/EGM confirmed for mechanical design. Mechanical requirements confirmed for Camera and Surgical Instruments. | |
| - Electrical requirements met | Instrument Arm/EGM confirmed for electrical requirements. Electrical requirements confirmed for Camera and Surgical Instruments. | |
| - Reliability verified | Instrument Drive confirmed for reliability. Re-use and reliability verified for Surgical Instruments and Accessories. | |
| - Chassis ground integrity | Instrument Drive confirmed for chassis ground integrity. | |
| - Mechanical stability of Surgeon Console | Surgeon Console confirmed for mechanical stability. | |
| - Cosmetic and labeling requirements met | Surgeon Console confirmed for cosmetic and labeling. Labeling confirmed for Camera, Surgical Instruments, and Accessories. | |
| - Pedal labels and layout specifications met | Foot Pedals confirmed for pedal labels and layout. | |
| - Pedal reliability sustained | Foot Pedals confirmed for pedal reliability. | |
| - Mechanical and electrical specifications met for foot pedals | Foot Pedals confirmed for mechanical and electrical specifications. Sensors verified. | |
| - Mechanical and electrical requirements met for Vision Cart | Vision Cart confirmed for mechanical and electrical requirements. | |
| - Safety and reliability of Vision Cart | Vision Cart confirmed for safety and reliability. | |
| - Labeling and cleanability of Vision Cart | Vision Cart confirmed for labeling and cleanability. | |
| - Camera interface with CCU | CCU confirmed for camera interface. | |
| - Camera control and video processing functionality | CCU confirmed for camera control and video processing. | |
| - Vision Cart compatibility | CCU confirmed for Vision Cart compatibility. | |
| - Safety and reliability of CCU | CCU confirmed for safety and reliability. | |
| - Noise level of CCU within limits | CCU confirmed for noise level. | |
| - Mechanical and electrical requirements of CCU | CCU confirmed for mechanical and electrical requirements. | |
| - Labeling and cleanability of CCU | CCU confirmed for labeling and cleanability. | |
| - Physical specifications (size, weight, materials) met for Camera | Camera confirmed for physical specifications. | |
| - Mechanical requirements (force, range of motion, accuracy) met for Camera | Camera confirmed for mechanical requirements. | |
| - Image quality of Camera | Camera confirmed for image quality. | |
| - Physical specifications (dimensions, weight, materials) met for Instruments | Surgical Instruments confirmed for physical specifications. | |
| - Mechanical requirements (force, range of motion, accuracy) met for Instruments | Surgical Instruments confirmed for mechanical requirements. | |
| - User interface and patient safety for Instruments | Surgical Instruments confirmed for user interface and patient safety. | |
| - Environmental requirements for Instruments | Surgical Instruments confirmed for environmental requirements. | |
| - Shipping and storage for Instruments | Surgical Instruments confirmed for shipping and storage. | |
| - Package and Labeling for Instruments | Surgical Instruments confirmed for package and labeling. | |
| - Physical specifications (size, weight, materials) met for Accessories | Accessories confirmed for physical specifications. | |
| - Mechanical and electrical requirements for Accessories | Accessories confirmed for mechanical and electrical requirements. | |
| Cadaver and Animal Validations | - Clinical performance for anatomical access and reach | Successfully demonstrated in 5 cadaver and 6 porcine procedures. |
| - Safety and performance in live tissue models | Successfully demonstrated in 6 porcine procedures and 5 cadaver models. | |
| - Appropriate hemostasis achieved and maintained | Assessed in live animal models. | |
| - Ability to perform surgical tasks (e.g., dissection, suturing, ligation) with comparable efficacy to predicate | Successful completion of specific success criteria for each procedure performed by 5 independent surgeons for both SP999 and IS3000. | |
| - Equivalence in surgeon's ability to perform tasks | Surgeons evaluated their ability to perform surgical tasks with both systems through questionnaires, indicating comparable performance. | |
| Human Factors Evaluation | - Use-safety and effectiveness of the system | Validated through a summative validation study with 15 user teams. |
| - Identification and assessment of unknown use-related hazards | Assessed during the validation study. | |
| - Ease of use | Evaluated during the validation study. | |
| - Effectiveness of user documentation | Assessed during the validation study. | |
| - Effectiveness of training material | Assessed during the validation study. | |
| Feasibility Study (Human Clinical Cases) | - Safety and effectiveness in human clinical setting | 30-day post-operative outcomes on 19 human clinical cases (11 prostatectomies, 4 nephrectomies, 4 partial nephrectomies) successfully performed with a functionally equivalent prototype. (Not used for SE determination but supportive evidence). |
2. Sample Size and Data Provenance
-
Test Set for Cadaver and Animal Validations (Comparative Study):
- Sample Size: 5 independent practicing surgeons. Each surgeon performed 7 urologic procedures in a cadaver model and 6 representative procedure steps in a porcine model for each system (SP999 and IS3000), totaling 65 surgical procedures per system. The individual procedures described in the table are the cases.
- Data Provenance: Not explicitly stated, but likely conducted in a controlled lab/testing environment, potentially in the US where the company is based. The data is prospective for this specific study.
-
Test Set for Cadaver and Animal Validations (Initial SP999 Evaluation):
- Sample Size: 11 procedures (5 cadaver, 6 porcine). The sample size applies to the number of procedures, not necessarily unique animals/cadavers, although it mentions "sample size = 1" in parentheses for the overall system evaluation, which is ambiguous but could imply one animal for each type of procedure or one overall comprehensive animal model.
- Data Provenance: Not explicitly stated, but likely from controlled lab/testing environments.
-
Test Set for Human Factors Evaluation:
- Sample Size: 15 teams of users (surgeons and patient side assistants). Each team represents one "case" for the human factors study.
- Data Provenance: Conducted in a simulated OR environment. Likely within the US. This is prospective data.
-
Test Set for Feasibility Study:
- Sample Size: 19 human clinical cases (11 prostatectomies, 4 nephrectomies, 4 partial nephrectomies).
- Data Provenance: "OUS feasibility study" (Outside the US), indicating an international origin. This is retrospective for the purpose of the 510(k) submission, as it was conducted with a prototype and submitted as supplementary evidence, not primary for SE.
3. Number of Experts and Qualifications for Ground Truth
-
For Cadaver and Animal Validations (Comparative Study):
- Number of Experts: 5 independent practicing surgeons.
- Qualifications: "independent practicing surgeons." Specific experience or specialization is only noted as "urologic surgical procedures." Given the procedures (pyeloplasty, nephrectomy, prostatectomy, lymphadenectomy), they are likely urologists with relevant surgical experience.
-
For Cadaver and Animal Validations (Initial SP999 Evaluation):
- Number of Experts: Not explicitly stated. Procedures were performed by "clinical development engineers." These are likely internal experts with specialized knowledge of the device and surgical procedures, but their clinical credentialing as surgeons isn't mentioned for this specific evaluation phase (they are performing the initial tests, not the comparative reader study).
-
For Human Factors Evaluation:
- Number of Experts/Users: 15 surgical urologists and 15 patient side assistants.
- Qualifications: Surgical urologists with varying experience (2 - 30 years in surgical practice, 13 - 1000 robotic surgical cases). Patient side assistants also varied in experience (55 - 40,000 cases, 0 - 9000 robotic patient side cases).
-
For Feasibility Study:
- Number of Experts/Users: Not explicitly stated for each case, but implies trained surgeons performed the procedures.
- Qualifications: Unspecified, but performing "human clinical cases" implies they were qualified surgeons.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method like "2+1" or "3+1" for establishing ground truth for the test sets. Instead, success criteria for each procedure were defined, and the performance against these criteria was observed and evaluated by the participating surgeons themselves (in the comparative study) or by clinical development engineers (in the initial evaluation). For human factors, objective performance data, use-errors, close calls, and subjective feedback were collected.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
-
Was a MRMC comparative effectiveness study done? Yes, a comparative study was conducted where five independent practicing surgeons (multiple readers) performed a comprehensive set of urologic surgical procedures (multiple cases) using both the SP999 (subject) and the IS3000 (predicate) systems.
-
Effect size of how much human readers improve with AI vs without AI assistance: This study does not evaluate AI assistance. The da Vinci system is a robotic surgical system that assists surgeons, but the context here is comparing a new version of the robotic system (SP999) against an older version (IS3000), not comparing human readers with and without AI assistance for interpretation tasks (e.g., radiology). The goal was to prove the substantial equivalence of the new robotic system, not to quantify improvement in human diagnostic performance with AI. The effect measured was the ability of surgeons to successfully complete defined surgical tasks with both systems. The document implies no statistically significant difference or inferiority of the new system compared to the predicate was found, as it concluded substantial equivalence. Specific quantitative improvements of surgeons using one system over the other are not detailed.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the device is a surgical system that requires human interaction, not a standalone diagnostic algorithm. The da Vinci system is not an AI algorithm operating independently; it is a human-controlled, electro-mechanical system.
7. Type of Ground Truth Used
- Bench Verifications: Engineering specifications, design requirements, and industry standards as the ground truth for mechanical, electrical, and functional performance.
- Cadaver and Animal Validations: Defined "success criteria" for each surgical procedure (e.g., "Anastomosis complete with no visible gaps," "Kidney completely freed"). The completion of these criteria by the surgeons or engineers served as the ground truth for performance. Tissue examination and physiological responses (e.g., hemostasis) in live animals also contribute to this.
- Human Factors Evaluation: Observational data (user's ability to complete tasks, identified use-errors, close calls, difficulties) and subjective feedback (ratings, interviews) were used to assess safety, usability, and effectiveness, with the "ground truth" being defined safe and effective operation based on risk analysis.
- Feasibility Study: 30-day post-operative outcomes on human patients. This is outcome data, serving as a form of ground truth for safety and effectiveness in a human clinical setting.
8. Sample Size for the Training Set
The document does not identify a distinct "training set" in the context of an algorithm or machine learning. The da Vinci system is a robotic system, and its development involves iterative design, testing, and feedback, rather than traditional machine learning training. The information provided describes verification and validation studies.
9. How the Ground Truth for the Training Set Was Established
Since there is no identified "training set" for an algorithm in the machine learning sense, this question is not applicable. The development of the da Vinci SP999 system involved engineering design and testing, where the "ground truth" for each component and system feature was established by engineering specifications, regulatory standards, and clinical input from experienced surgeons guiding the design process. Formative testing and an earlier clinical investigation provided feedback that led to design iterations and improvements.
§ 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.