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The Intuitive Surgical Endoscopic Instrument Control System, Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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 laparosopic 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 Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System Model IS3000) is intended to r no multive accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp assist in the dissectors, 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 approximation against, orceral procedures, general laparoscopic surgical procedures, gynecologic probos and acoussent anning actrage tal otolaryngology surgical procedures restricted to benign and malignant itumors classified as T1 and T2, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy rumors clasmed as 1 x and 12, gateda adjunctive mediastinotomy to perform coronary anastomosis during procedurer The system is indicated for adult and pediatric use. It is intended to be used by trained earchies in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 184200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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 laparosopic 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 da Vinci Surgical Systems (Models IS3000, IS4000 and IS4200) are software-controlled, electromechanical systems designed for surgeons to perform minimally invasive surgery. The da Vinci Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The provided text is a 510(k) summary for the da Vinci Surgical System, focusing on a labeling change rather than a study proving performance against acceptance criteria for a new device or significant modification.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in this document. This 510(k) is specifically for a minor administrative change (a labeling update to contraindications), not a clinical performance study.

Here's an explanation of what can and cannot be answered based on the provided text:

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

• Not applicable / Not provided. The document describes a change to labeling (contraindications) for existing devices already on the market, not a new device or a performance enhancement that would require a study with acceptance criteria.

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

• Not applicable / Not provided. No test set or clinical study data is presented as this submission is for a labeling change.

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)

• Not applicable / Not provided. No ground truth establishment is described as there is no clinical study.

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

• Not applicable / Not provided. No test set or adjudication process is mentioned.

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

• Not applicable / Not provided. This device is a surgical system, not an AI-assisted diagnostic tool or an "AI" in the typical sense that would involve human "readers" or an MRMC study comparing AI assistance.

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

• Not applicable / Not provided. The da Vinci system is a human-controlled surgical system. There is no standalone "algorithm-only" performance to evaluate in this context.

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

• Not applicable / Not provided. No ground truth is established as there is no performance study.

8. The sample size for the training set

• Not applicable / Not provided. No new algorithm or trainable component is described in this 510(k) submission that would require a training set.

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

• Not applicable / Not provided. No training set is involved.

Summary of the document:

This 510(k) submission (K171699) by Intuitive Surgical, Inc. is a Special 510(k) for their da Vinci Surgical Systems (Models IS3000, IS4000, IS4200). A Special 510(k) is typically used for well-defined modifications to a manufacturer's own legally marketed device that do not affect the indications for use or alter the fundamental scientific technology of the device, and for which the risk of the modification can be adequately assessed by the manufacturer's design controls.

In this specific case, the modification is a labeling change to the "General Warnings and Cautions" section in the User Manuals, specifically concerning the endoscopic contraindication statement. The submitter argues that this change:

• Does not change device usage or the patient population.
• Does not change the risk profile of the devices.
• Adequately instructs the user.

Therefore, the submission concludes that the modified devices (with the updated labeling) are substantially equivalent to the predicate devices because the labeling modification has no impact on the safety or effectiveness of the da Vinci Surgical Systems themselves. This type of submission does not involve clinical studies or performance data against specific acceptance criteria for a new or significantly modified device function.

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