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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.

EndoWrist SP 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 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 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 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 the surgical port and to manipulate the surgical instruments and is positioned at the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The 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.

The provided text does not contain information about specific acceptance criteria, study details, or performance metrics for the da Vinci SP Surgical System (SP1098).

The document is a 510(k) premarket notification clearance letter from the FDA. It states that the device is "substantially equivalent" to a legally marketed predicate device (K202968, Da Vinci SP Surgical System). The clearance is based on a review of the device's indications for use and a comparison to the predicate device.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that:

• Nonclinical testing was "limited to software verification and a human factors evaluation, analogous to the testing of Dual Console mode for the reference device."
• Verification and validation testing "confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified, analogous to the reference device verification and validation testing for Dual Console mode."

This means the study described is primarily a software verification and validation and a human factors evaluation focused on the new "Dual Console" feature, rather than a clinical trial or performance study against specific acceptance criteria for the surgical system's overall function. The FDA's decision relies on the analogy to the predicate device's prior substantial equivalence determination.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 based on the provided text. The document does not describe:

• Specific acceptance criteria for the device's clinical performance.
• Reported device performance against such criteria.
• Sample sizes for test sets (beyond general software V&V or human factors, which are not detailed).
• Data provenance, expert qualifications, or adjudication methods for ground truth because a clinical performance study with such elements is not described.
• Whether MRMC or standalone performance studies were done for clinical effectiveness.
• Type of ground truth used for performance validation.
• Training set sample size or how ground truth was established for a training set, as it seems the evaluation focused on incremental changes rather than a de novo AI performance assessment.

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