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da Vinci SP® Surgical System, Model SP1098:
The Intuitive Surgical® Endoscopic Instrument Control System (da Vinci SP® Surgical System, Model SP1098) 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 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 SPTM Instruments:
Intuitive Surgical® EndoWrist SP™ Instruments are controlled by the da Vinci SP® Surgical System, Model SP1098, 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 laparoach. 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.

Device Description

The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electromechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 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.

The surgeon seated at the Surgeon Console controls all movement of the EndoWrist SP Instruments and Camera Instrument 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 Vision Cart includes the supporting electronic and video processing equipment for the system.

The Patient Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, threedimensional view of the patient anatomy. A suite of EndoWrist SP Instruments can be attached to and detached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instrument and up to three surgical instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an obturator, a seal, an entry guide, disposable tips for selected instruments, instrument sheaths, and a drape are needed to perform procedures with the system.

The EndoWrist SP Instruments come in various configurations such as graspers, scissors, and needle drivers. The EndoWrist SP instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y-Z movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The EndoWrist SP Instruments can be used only with the SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.

The EndoWrist SP Camera Instrument is a reusable endoscope that provides a stereo image of the surgical site. Like the instruments, the distal end includes multiple joints that provide the flexibility needed for use with a single-port system.

AI/ML Overview

This document describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (referred to as "the device" or "SP1098 system") and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device (Model SP999) and that design output meets design input requirements. The "performance" is generally reported as successful completion of these tests, confirming the device's ability to operate as intended and safely.

Below is a summary of the performance studies conducted and the reported outcomes:

Study Type	Acceptance Criteria (Implied / Reported Outcome)	Reported Device Performance
Bench Performance Testing	General: Design output meets design input requirements; mechanical and electrical specifications are met; components function as intended; image quality, physical specifications, mechanical requirements, equipment interfaces, re-use and reliability, environmental requirements, shipping, storage, package and labeling requirements are met.	SP1098 Patient Cart & Subassemblies: Subjects to full design verification to mechanical/electrical specifications, including brake forces, safety, lower-risk mechanical requirements, miscellaneous design features, external testing, applied loads, interfaces, mechanical design, electrical requirements, and reliability. SP1098 Surgeon Console: Verification testing confirmed modifications (foot pedals) meet electrical and mechanical specifications (mechanical stability, cosmetic/labeling, pedal labels/layout, pedal reliability, sensors). SP1098 Vision Cart: Verification testing confirmed modifications (EnergyShield Monitor addition) meet electrical/mechanical specifications, and design verification performed for EnergyShield Monitor (physical features, layout, equipment interfaces, electrical requirements, safety, environmental, labeling). SP1098 Surgical Instruments & Camera: Testing performed to verify design meets physical/mechanical/user interface/equipment interface requirements (size, weight, materials, force, range of motion, accuracy, electrical/patient safety, image quality, re-use/reliability, environmental, shipping/storage, package/labeling). SP1098 Accessories: Testing performed to verify design meets physical/mechanical/user interface/equipment interface requirements (size, weight, materials, mechanical/electrical, equipment interfaces, re-use/reliability, package/labeling). Overall: "The bench performance testing verified that the design requirements and specifications for the new and/or changed components of the system are met."
Cadaver Testing	Device performance demonstrated for anatomical access and reach in various specific urological procedures (pelvic lymphadenectomy, colectomy, radical prostatectomy, pyeloplasty, total nephrectomy, partial nephrectomy). Specific success criteria for each procedure: Anastomosis complete and acceptable, critical anatomy identified, kidney completely freed, lymph nodes freed, prostate removed, urethrovesical anastomosis complete and acceptable, dissection borders achieved, fine dissection ability, suturing ability, and needle handling.	Nine procedures performed (6 cadaver, 3 porcine). Cadaver specific procedures: Pelvic lymphadenectomy (enables evaluation of pelvic access and precise dissection around vessels), Colectomy (evaluation of range of motion and work volume, instrument/grip strength), Radical Prostatectomy (assessment of deep pelvis access and suturing in confined space), Pyeloplasty (assessment of renal access and suturing small/thin tissues), Total Nephrectomy (evaluation of renal access, fine dissection, instrument strength/range of motion), Partial Nephrectomy (evaluation of fine dissection, suturing delicate tissue, needle handling). Specific performance for the 3 independent surgeons: Anastomosis complete and deemed acceptable upon visual inspection, critical anatomy identified, kidney/lymph nodes completely freed, prostate removed, urethrovesical anastomosis complete and acceptable, dissection borders achieved, hemostasis maintained, 2cm defect removed and closed, renal vein and artery successfully ligated, 3cm length of bladder neck/urethra mobilized. Overall: "The cadaver performance testing validated the users' ability to use the system to accurately control the endoscopic instruments, to reach the necessary target anatomy, and to perform surgical tasks."
Animal (Porcine) Testing	Safety and performance assessed in live tissue models where appropriate, including working with perfused organs, bleeding, normal tissue handling, achieving/maintaining hemostasis. Specific success criteria for each procedure: Anastomosis complete and acceptable, hemostasis maintained, 2 cm diameter defect removed and closed, renal vein and artery successfully ligated, kidney freed, bladder neck/urethra mobilized, lymph node freed.	Live animal specific procedures (porcine): Partial nephrectomy (fine dissection in live tissue, suturing delicate tissue, needle handling), Renal artery ligation/transection/anastomosis (effectively ligating blood vessels, transecting thin tissue, precise suturing/manipulation), Bladder neck dissection/transection/urethrovesical anastomosis (dissecting deep in pelvis, transecting/manipulating/suturing thick tissue, needle handling). Similar successful outcomes as described for cadaver testing. Overall: "The simulated and representative urological procedures in live animals provided validation that the system can safely and effectively complete representative urologic procedures encompassed by the indications for use statement."
Human Factors (HF) Study	Usability risk analysis updated, mitigations implemented, use-related risks identified, previously unknown hazards addressed, safety and effectiveness validated, residual risk at acceptable level, ease of use evaluated, effectiveness of user documentation and training material assessed. Identification and mitigation of use-related risks associated with the SP1098 system.	Formative testing: Conducted on complete system prototypes and individual user interface features; helped identify use-related risks. Summative validation study: Conducted in a simulated operating room; involved 15 surgical teams and 15 prep teams; evaluated high-risk use scenarios and essential tasks, including emergency procedures (e.g., EnergyShield Monitor fault); training materials and user manuals assessed. Data collected included objective performance (observations of task completion, use errors, close calls, difficulties) and subjective feedback (open-ended questions, multiple choice ratings, follow-up interviews). Overall: "The human factors engineering process, culminating in a summative usability validation study, was used to identify and assess the use-related risks associated with the SP1098 system. The safety and usability of the SP1098 were assessed to ensure that residual risk is at an acceptable level, and new hazardous use scenarios identified during testing were assessed according to an accepted risk management process and updated in the usability risk analysis for the SP1098 system."
Substantial Equivalence	The device is substantially equivalent to the predicate device based on intended use, indications for use, technological characteristics, and performance data.	The FDA concluded, "Based on the intended use, indications for use, technological characteristics and performance data, the Intuitive Surgical da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories, is substantially equivalent (SE) to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Cadaver and Animal Performance Testing:
- Cadaver Models: 6 cadaver procedures were performed.
- Porcine Models: 3 porcine (live animal) procedures were performed.
- Surgeons: 3 independent practicing surgeons participated. Each performed 7 urologic procedures in cadaver models and 5 representative and simulated procedures in porcine models, totaling 36 surgical procedures.
- Data Provenance: Not explicitly stated, but cadaver and porcine models are used, generally implying controlled laboratory or surgical simulation environments. The participants are "independent practicing surgeons," suggesting their experience is relevant to real-world clinical practice, but the tests themselves were in simulated environments. It's a prospective study in the sense that the device was specifically tested in these models.
Human Factors (HF) Performance Testing:
- Participants: A total of 15 surgical teams (surgeon and patient-side assistant) and 15 prep teams (scrub tech and circulating nurse).
- Data Provenance: The study was conducted in a "simulated operating room environment," involving controlled, prospective testing scenarios.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Cadaver and Animal Performance Testing: The "ground truth" for the success criteria (e.g., "Anastomosis complete and deemed acceptable upon visual inspection," "Critical anatomy identified," "Hemostasis maintained") was implicitly established by the 3 independent practicing surgeons who performed the procedures and evaluated the outcomes. Their qualifications are stated as "independent practicing surgeons," implying they are qualified by their profession and experience to make these assessments.
Human Factors Testing: The "usability risk analysis was developed with feedback from internal functional group experts." The qualifications of these internal experts are not specifically detailed (e.g., years of experience, specific certifications), but they are described as "functional group experts."

4. Adjudication Method for the Test Set

Cadaver and Animal Performance Testing: The document does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus) for the surgical outcomes. The success criteria imply a direct assessment by the performing surgeons. It might be assumed that for critical assessments like "acceptable upon visual inspection," the surgeons' professional judgment served as the "adjudication."
Human Factors Testing: "The SP1098 usability risk analysis was updated throughout the design process as formative testing was conducted, system design was iterated, new use errors were identified, and new mitigations were implemented." This suggests an iterative process where identified issues were reviewed and addressed, but a specific "adjudication method" for individual use errors is not detailed. Objective performance data and subjective feedback were collected and presumably interpreted by human factors experts.

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 MRMC comparative effectiveness study was done. This device is a surgical system, not an AI-assisted diagnostic or interpretation tool for "readers." The performance studies focused on the surgical system's ability to perform procedures, safety, and usability.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a surgical system that requires a human surgeon for operation (human-in-the-loop). It is not a standalone algorithm. The "standalone" aspect that could be considered is the system's electromechanical function and software control, which were tested via bench performance without direct human interaction for some aspects, but the overall product is user-dependent.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For Cadaver and Animal Testing: The ground truth was based on the expert assessment and visual inspection of the surgical outcomes by "independent practicing surgeons" against predefined success criteria (e.g., "Anastomosis complete and deemed acceptable," "Kidney completely freed," "Hemostasis maintained"). No mention of pathology or long-term outcomes data for these specific tests.
For Human Factors Testing: The ground truth for identifying usability issues and risks was based on observations of user performance (objective data) and user feedback (subjective data) during simulated scenarios, interpreted by human factors experts.

8. The Sample Size for the Training Set

Not explicitly stated for an AI/algorithm context. This device is a robotic surgical system, not a machine learning model that undergoes "training" in the traditional sense with a distinct training dataset. Its development likely involved iterative design and testing using various models and prototypes, which could be seen as its "training" or development phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the context of an AI training set for this type of medical device. The "ground truth" for the device's design and engineering development (analogous to a training set in ML) would have been established through engineering specifications, design input requirements, and previous historical data/knowledge from predicate devices (e.g., da Vinci SP999, da Vinci Xi IS4000). These requirements and the "truth" of their fulfillment were then verified through the detailed bench, cadaver, animal, and human factors testing described.

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