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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 SP Instruments during urologic, colorectal, and general thoracoscopic 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.

da Vinci SP Instruments:

Intuitive Surgical da Vinci 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, colorectal, and general thoracoscopic 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, Model SP1098, is a software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories.

The provided FDA 510(k) Clearance Letter for the da Vinci SP Surgical System (K251324) does not contain the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

This document is for a robotic surgical system, not an AI/ML software device for diagnostic or analytical purposes. The clearance focuses on hardware, software for controlling the hardware, and human factors related to the physical use of the surgical system.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics for an AI/ML algorithm or corresponding acceptance criteria.
2. Sample sizes used for the test set and the data provenance: No test set, data provenance, or sample sizes related to an AI/ML model are mentioned.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as there's no AI/ML model for which ground truth would be established by experts for performance evaluation.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes human factors evaluation related to the usability of the surgical system, not diagnostic performance with AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no standalone AI algorithm being cleared.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document mentions "Software verification and validation have been conducted at the unit, integration, and system level to confirm that the subject devices continue to meet design requirements and user needs" and "Human Factors Evaluation including usability validation has been conducted to demonstrate safety and effectiveness." These are general statements about software and usability testing for a medical device, but they do not detail the specific performance metrics, acceptance criteria, or study designs typically used for AI/ML devices as requested in the prompt.

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