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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi Surgical System, Model IS4000 and da Vinci X Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, 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, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The modifications to the da Vinci Xi and X Surgical Systems adds a hardware component called the Advanced Processor (AP4000) as well software components, both on the Advanced Processor and a separate iOS app, to the surgical system.

These modifications enable the following functionality: Video recording/Image capture, WiFi pairing of iOS devices with the Advanced Processor, an iOS app to view live endoscopic video once the iOS device has been paired and data logging on the AP4000 hard disk (stereo endoscopic video, kinematics and real time events). This allows surgeons to initiate and control video recordings as well as capture endoscopic images. These modifications also allow OR staff and others present in the OR to pair their iOS mobile devices with the Advanced Processor in order to view the live endoscopic video.

This FDA 510(k) summary describes modifications to the da Vinci Xi and X Surgical Systems, not a new AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies and acceptance criteria is not applicable to this document. The document focuses on regulatory clearance for hardware and software modifications that enhance existing functionalities of a robotic surgical system, rather than an AI-driven diagnostic or treatment recommendation system requiring clinical performance studies against a ground truth.

Specifically, the modifications enable:

• Video recording/Image capture.
• WiFi pairing of iOS devices with an Advanced Processor.
• An iOS app to view live endoscopic video.
• Data logging (stereo endoscopic video, kinematics, real-time events).

The submission asserts that these modifications do not affect the substantial equivalence of the device to its predicate because "verification and validation testing have established there are no new issues of safety or effectiveness."

Here's an attempt to answer the questions based on the provided document, highlighting what is not applicable due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for modifications to an existing device, and not a new diagnostic or prognostic AI/ML device, there are no specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) reported in this document. The "acceptance criteria" for these modifications appear to be successful completion of verification and validation testing, and compliance with relevant standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes verification and validation testing of software and hardware modifications for a robotic surgical system, not a clinical study involving a test set of patient data for an AI/ML diagnostic or prognostic algorithm. The testing would involve engineering and software validation tests, not clinical data sets in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth establishment by experts is relevant for AI/ML algorithms performing tasks like diagnosis or detection. The current submission focuses on verifying the functionality and safety of video recording, streaming, and data logging features.

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

This information is not applicable for the same reasons as #3.

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

This information is not applicable. The device provides tools for surgeons (video recording, streaming), but it is not an AI assistant meant to improve human reader performance in interpreting medical images or data.

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

This information is not applicable. The modifications are for a human-controlled surgical system, enhancing its capabilities rather than introducing a standalone AI algorithm.

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

This information is not applicable. The "ground truth" for the verification and validation of these modifications would be the functional specifications and safety requirements met through engineering and software testing.

8. The sample size for the training set

This information is not applicable. This document does not pertain to the development or validation of an AI/ML algorithm that would require a training set.

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

This information is not applicable. As no AI/ML training set is mentioned or implied, the method for establishing its ground truth is irrelevant to this submission.

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