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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 and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. 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.

Endo Wrist SP Instruments:

Intuitive Surgical Endo Wrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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 port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign turnors and malignant tumors classified as T1 and T2. 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 is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

This 510(k) is for a labeling modification only, to add "simple prostatectomy" as a new representative, specific procedure in the Professional Instructions for Use. Simple prostatectomy is a "covered" procedure under radical prostatectomy as an "umbrella" procedure. This 510(k) also includes the addition of performance data (cadaver) for "transvesical prostatectomy" as validated approach for prostatectomy in the Performance Data section of the User Manual.

The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It primarily discusses a labeling modification to add "simple prostatectomy" as a representative procedure and the justification for this change. The document does not describe acceptance criteria for a device performance study in the typical sense of a new device validation with specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence by comparing performance data from literature for different prostatectomy approaches.

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance (as inferred from the provided text):

The "acceptance criteria" here are not explicitly stated numerical thresholds for performance. Instead, the inherent acceptance criterion is that the new procedure ("transvesical prostatectomy" for both simple and radical cases) performed with the da Vinci SP Surgical System demonstrates similar clinical outcomes to previously cleared prostatectomy approaches (extraperitoneal and transabdominal radical prostatectomy) performed with the same device. This demonstrates "substantial equivalence" and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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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 and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant turnors classified as T1 and T2. 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.

Intuitive Surgical® Endo Wrist SP® Instruments are controlled by the da Vinci SP® Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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 port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors classified as T1 and T2. 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 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 surgical 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.

The provided FDA 510(k) summary (K182371) describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories. This document primarily focuses on demonstrating substantial equivalence to predicate devices for use in transoral otolaryngology surgical (TORS) procedures for benign and malignant (T1 and T2) oropharyngeal tumors.

It's important to note that this document does not describe an AI/ML-driven device; rather, it details a robotic surgical system that assists human surgeons. Therefore, information related to AI-specific criteria (like AI vs. human reader improvement, standalone AI performance, training set sample size/ground truth) is not applicable or present in this filing.

Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text, specifically for the expansion of indications to include TORS:

Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are not explicitly listed in a separate table titled "acceptance criteria" but are implicitly derived from the comparative effectiveness study against a predicate device and the clinical study endpoints for safety and performance. The FDA's determination of substantial equivalence relies on the new device being as safe and effective as the predicate and not raising new questions of safety or effectiveness.

*Note: Confidence intervals for da Vinci SP are Wilson Score 95% CI where applicable, and Agresti Coull 95% CI for conversion rate.

Study Design Details

2. Sample size used for the test set and the data provenance

• Clinical Study (Confirmatory):
  • Sample Size: N=33 subjects for the da Vinci SP Surgical System for TORS.
  • Data Provenance: Prospective, multicenter, single-arm clinical study conducted in the United States (NCT03049280, IDE #G160251).
• Pre-clinical Study (Cadaver and Animal Testing):
  • Cadavers: A sufficient number to demonstrate anatomical access and reach.
  • Live Porcine Models: A sufficient number to assess safety and performance in live tissue.
  • Data Provenance: Conducted as part of the pre-clinical investigation to support the expanded indication.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Pre-clinical Study (Cadaver and Animal Testing): Three (3) independent practicing surgeons participated. No specific qualifications beyond "independent practicing surgeons" are provided. These surgeons evaluated their ability to perform surgical tasks and procedures.
• Clinical Study: The "ground truth" for clinical outcomes (e.g., successful procedure, complications) would be established by the treating physicians and study investigators at the three participating institutions, typically qualified medical professionals (surgeons, oncologists, etc.), though their specific experience level is not detailed in this summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The text does not explicitly describe an adjudication method for disagreements among experts or for clinical endpoints. In the cadaver/animal study, surgeons completed questionnaires, implying individual assessment. For clinical studies, safety and performance outcomes are typically recorded directly by the sites and reviewed by study monitors and investigators.

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

• MRMC Study: No, this device is a robotic surgical system, not an AI diagnostic tool involving "human readers." Therefore, an MRMC study and effect size relating to human readers with/without AI assistance are not applicable.

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

• No, this device is a surgical assistance system that requires a human surgeon "in the loop" for all aspects of its operation. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Pre-clinical Testing: Surgical success criteria (e.g., resection volume, boundary achievement, critical anatomy identification, hemostasis, no trauma) as assessed by participating surgeons. This aligns with a form of expert assessment/consensus on surgical outcomes in non-human models.
• Clinical Study: Outcomes data from human subjects, including operative parameters (e.g., operative time, blood loss), safety endpoints (device-related adverse events, intraoperative complications), and clinical outcomes (e.g., conversion to open surgery, hospital stay, mortality, readmission, reoperation, postoperative complications). Pathological reports would be part of verifying tumor classification (T1, T2) which is part of the inclusion criteria, but the "ground truth" for the device's performance itself is the clinical outcomes.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a distinct "training set" in the context of machine learning. The device design and refinement would be based on engineering principles and iterative testing, not a data-driven training process in the AI sense.

9. How the ground truth for the training set was established

• Not applicable as it's not an AI/ML device.

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