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da Vinci SP Surgical System (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 three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.

At the Surgeon Console, the surgeon controls all movements and endoscope by using two hand controls and a set of foot pedals. The surgeon views the live endoscope 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 endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.

The provided text is a 510(k) summary for the da Vinci SP Surgical System (SP1098). It details the device's indications for use, its description, and a comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria for device performance, nor does it describe a study (including sample sizes, ground truth establishment, or expert adjudication) that proves the device meets such criteria.

The document states: "Verification and validation testing, consisting of software testing, and clinical validation, on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate device, the test results demonstrate that the subject device is substantially equivalent to its predicate device."

While it mentions "clinical validation" and "acceptance criteria," it does not provide the details requested in your prompt. The focus of this 510(k) summary is on demonstrating substantial equivalence to a predicate device, primarily through technological comparison and by asserting that the new device met the same acceptance criteria as the predicate. It does not elaborate on what those criteria were or the specifics of the study that validated them.

Therefore, I cannot fulfill your request for the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based on the provided text. This document is a regulatory submission summary, not a detailed study report.

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