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Indications For Use - da Vinci Connect:

The da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000.

Indications For Use - da Vinci OnSite:

The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.

The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and da Vinci OnSite, is a minor modification to the existing computer assisted device designed to facilitate complex surgery using minimally invasive approach. An overview of the IS2000 consists of the following three main integrated sub-systems: The Surgeon Console, Model SS2000: The control center of the surgical system, and allows the surgeon to control critical aspects of the surgical procedure (including movement of the endoscopic instruments and endoscope). Instrument and camera movements are controlled by the Master Tool Manipulators (MTM), two hand operated controllers, and foot pedals at the Surgeon Console's base. These allow the surgeon to be as dexterous as in "open" surgery. while operating in a minimally invasive environment. The surgeon has the option to change the surgical view from full screen mode to a multi-image mode, which displays an optional 3- dimensional High Definition (3-D HD), 3-D, or 2-D standard definition image of the operative field.

The Patient Side Cart (PSC, Model PS2000): The operative component of the surgical system within the sterile field. Its primary function is to support the endoscopic instrument arms and camera arm, during surgical procedures. Endoscopic instruments are held in a fixed position (with respect to the patient) by unique Patient Side Manipulators (PSM), and the endoscope is held by the Endoscope Camera Manipulator (ECM). The PSM's and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console are relayed to the PSC, via a cable.

InSite ® Vision System (Model VS2000): Houses the system's image processing equipment and is operated by a person outside the sterile field during surgery. The cart provides space for an optional touch screen monitor, as well as ancillary surgical equipment. The VS2000 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 image (or alternatively a 2-D) of the surgical field for the surgeon's reference.

The provided text describes a 510(k) submission for the Intuitive Surgical da Vinci S Surgical System, Model IS2000, with da Vinci Connect™ and da Vinci OnSite™. This submission is a request for clearance for minor modifications to an existing device, not a new device requiring extensive clinical trials to establish de novo safety and effectiveness.

Therefore, the information typically associated with acceptance criteria and studies proving the device meets those criteria (such as detailed performance metrics, sample sizes for training/test sets, ground truth establishment, or specific study designs like MRMC or standalone performance) is not present in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to establishing new safety and effectiveness for a novel device.

The study presented is a comparison to predicate device and a performance design analysis to demonstrate substantial equivalence, rather than a clinical study with detailed performance metrics against acceptance criteria.

Here's an analysis based on the information provided, highlighting what is available and what is explicitly not available or applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria and Performance: For this 510(k) submission, the "acceptance criteria" are predominantly framed around demonstrating substantial equivalence to an already legally marketed predicate device. This means the primary "performance" reported is the demonstration that the modified device performs as intended and is as safe and effective as the predicate, without introducing new risks. Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific tolerances) for the new functionalities (Connect and OnSite) are not detailed in this summary, as the modifications are described as "minor" and primarily involve communication and diagnostics.

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

• Sample Size for Test Set: Not applicable/Not provided. This submission is for a modification to an existing surgical system, not a diagnostic device requiring a "test set" of patient data for performance evaluation in the typical sense. The "studies" conducted were design analysis, bench testing, and risk analysis.
• Data Provenance: Not applicable/Not provided. No patient or clinical data sets are mentioned or used in this summary. The evaluation is based on design, engineering analysis, and bench testing.

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

• Not applicable/Not provided. No "ground truth" for patient data was established, as this was not a clinical or diagnostic performance study on patient cases. The evaluation concerned the engineering and functional equivalence of hardware and software modifications.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. As there was no test set of patient data, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No. An MRMC study was not done. These studies are typically for evaluating the impact of a new diagnostic technology on human reader performance, which is not the scope of this submission. The "da Vinci Connect" allows a proctor to provide advice, but this submission does not contain a study quantitatively measuring the effect size of this assistance on surgical outcomes or human reader performance.

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

• Not applicable/Not provided. This is not an AI or algorithm-only device. The "da Vinci Connect" is an accessory for human proctors to communicate and advise, and "da Vinci OnSite" is for customer service personnel to diagnose system faults. Neither is a standalone algorithm whose performance would be independently assessed in this manner.

7. The Type of Ground Truth Used

• Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) doesn't apply to this submission, as it's not a diagnostic or treatment outcome-measuring device in the context of this modification. The "ground truth" for the engineering performance and safety would be the established specifications and safety profiles of the predicate device, against which the modifications were compared through design analysis and bench testing.

8. The Sample Size for the Training Set

• Not applicable/Not provided. There is no "training set" in the context of machine learning for this device submission.

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

• Not applicable/Not provided. As there was no training set for machine learning, this information is not relevant to the submission.

Summary Conclusion for this Submission:

This 510(k) submission for the da Vinci S Surgical System with da Vinci Connect and da Vinci OnSite is a request for clearance based on substantial equivalence to existing predicate devices. The modifications are described as "minor hardware modifications" to support new communication and diagnostic features.

The "study" or evidence presented for FDA clearance relies on:

• Design analysis and comparison: Demonstrating that the modified components function as intended and do not alter the core safety or effectiveness of the surgical system.
• Bench testing: Verifying the performance of the new components and their integration.
• Risk analysis activities: Ensuring that the modifications do not introduce new, unacceptable risks.

The document explicitly states that the device "does not raise any new safety or effectiveness issues" and that its "indications for use remains unchanged from the predicate device" (for the core system). The new functionalities (Connect and OnSite) have their own stated intended uses, but their acceptance is based on demonstrating that they function correctly and safely within the existing system, rather than through complex clinical performance studies with patient data.

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