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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 tumors classified as T1 and T2. The system is indicated for 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, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation 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 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 table 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.

The design modifications included in this submission are limited to updated system software, additional labeling, and additional hardware used to connect the device to a remote Intuitive server. These changes are being made to facilitate remote technical support and servicing of the device.

The information provided focuses on the regulatory clearance of the da Vinci SP Surgical System. It details the device's description, indications for use, comparison with a predicate device, and performance data related to modifications for remote technical support and servicing. However, it does not contain the specific acceptance criteria and detailed study information (like sample sizes for test/training sets, experts' qualifications, adjudication methods, or MRMC study results) typically associated with establishing the diagnostic performance or clinical effectiveness of a medical device in detecting a condition or influencing clinical outcomes.

Instead, the document highlights testing related to:

• System software changes: Verification of risk mitigations, requirements, and specifications related to networking.
• Cybersecurity-related testing: Alignment with FDA Draft Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
• Safety and EMC standards: Evaluation against IEC 60601-1-2.
• Networking hardware testing: Manual bench testing for physical installation, security of ports, dimensions, connectivity, and startup/shutdown.
• Wireless coexistence testing: To validate suitability of the Wireless Bridge in a simulated use environment against RF interference, ensuring accurate detection of instruments and endoscopes.

The conclusion states that no issues of safety or effectiveness and no new risks were identified from these modifications, and the device is substantially equivalent to the predicate. This suggests the performance data presented is focused on validating the modifications to the system (networking, software updates for remote access) rather than its core surgical performance (which would have been established during the predicate device's clearance).

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the typical sense of a diagnostic or therapeutic clinical trial, nor can I provide details on sample sizes for test sets, expert qualifications, or comparative effectiveness studies of human readers with/without AI assistance, as these are not discussed in the provided text.

The closest analogue to "acceptance criteria" for the modifications described would be the successful completion of the various tests (cybersecurity, EMC, wireless coexistence, hardware bench testing) without identifying new safety or effectiveness concerns. The "study" proving this is the sum of these verification and validation activities.

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