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The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic surgical procedures. This 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.

This 510(k) is being submitted for an expansion of the Indications for Use to include gynecologic laparoscopic surgical procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the da Vinci Surgical System associated with this pre-market notification.

The da Vinci Surgical System consists of two integrated sub-systems as follows:

Intuitive Surgical Endoscopic Instrument Control System: This subsystem is comprised of the Surgeon Console and Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field. Endoscopic instrument and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The endoscopic instruments are held in a fixed position (with respect to the patient) by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC. Commands from the Surgeon Console are relayed to the PSC, which is located immediately adjacent to the patient, via cables, Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC.

Intuitive Surgical Stereo View Endoscopic System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite® Vision System, consists of a stereo endoscope, endoscopic camera, and various accessories, including a light source and light guides. The Insite Vision System provides two independent images that are relayed to the viewer located in the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D image) image of the surgical field.

The provided text is a 510(k) summary for the Intuitive Surgical da Vinci Surgical System, specifically for an expansion of its indications for use to include gynecologic laparoscopic surgical procedures. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically find for a new diagnostic AI device or a device requiring new performance claims.

Instead, the submission argues for substantial equivalence based on the existing device's proven performance in other surgical specialties and a comparison of surgical tasks.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The submission argues for substantial equivalence based on the device's existing clearance for a "full array of surgical tasks across multidisciplinary surgical specialties" and a "comparison of surgical tasks performed in cleared procedures to those performed in gynecologic laparoscopic surgical procedures."

Essentially, the "acceptance criteria" here implicitly refer to the established safety and effectiveness of the existing da Vinci system, and the "reported device performance" is its proven ability to perform surgical tasks in general. The document asserts that no new safety or effectiveness issues arise from extending its use to gynecologic procedures.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The submission relies on a "design analysis and comparison" and "design validation" rather than a clinical trial with a distinct test set of patient data to evaluate performance for the new indication.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. As there's no clinical test set in the traditional sense, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned. This type of study is more common for diagnostic devices measuring human reader performance. The da Vinci system is a surgical tool, and the submission focuses on its mechanical and functional equivalence for surgical tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. The da Vinci Surgical System is explicitly a "human-in-the-loop" device, as surgeons control the instruments. The concept of "standalone" performance without the human surgeon is not applicable here.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the established safety and effectiveness profile of the da Vinci Surgical System in its already cleared indications, and the similarity of surgical tasks in gynecologic laparoscopic procedures to those where the device is already cleared. The document states:

• "a comparison of surgical tasks performed in cleared procedures to those performed in gynecologic laparoscopic surgical procedures with the system."
• "design analysis and comparison, has been conducted to confirm that basic functional characteristics are substantially equivalent to the predicate devices cited, and design validation confirm that there are no new issues of safety or effectiveness for performing surgical tasks in gynecologic laparoscopic surgical procedures."

This is a form of "comparison to predicate" and "design validation" based on expert surgical knowledge and engineering principles, rather than a quantifiable ground truth derived from pathology or outcomes data in a new clinical study for this specific indication.

8. The Sample Size for the Training Set

This information is not provided. The da Vinci system is a robotic surgery system, not a machine learning algorithm that is "trained" on a dataset in the typical AI sense for image analysis or diagnosis. Its "training" would be more akin to engineering development and refinement based on extensive R&D and clinical experience in other surgical fields.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, as the concept of a "training set" and "ground truth" in the AI sense does not directly apply to the approval process described here for a surgical robotic system's expanded indication for use. Its operational "ground truth" is defined by its engineering specifications, safety parameters, and successful performance in prior surgical applications.

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