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The Intuitive Surgical® da Vinci® Surgical System is intended to assist in the accurate control of Intuitive Surgical® Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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 ablation probos and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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 Surgical System, consists of three integrated sub-systems as follows: Endoscopic Instrument Control System: The Endoscopic Instrument Control System is comprised of two sub-systems - the Surgeon Console, Model IS2000-SSC, and Patient Side Cart. Model IS2000-PSC. 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 manipulators 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 manipulator, similar to the PSM, known as the Endoscope Camera Manipulator (ECM) and also located on the PSC). The PSM 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, which is located immediately adjacent to the patient, via a cable. Instrument and endoscope changes are performed by another provider positioned adjacent to the PSC. Stereo View Endoscopic Vision System: The endoscopic vision system used with the da Vinci Surgical System, also known as Intuitive Surgical Insite Vision System. Model VS1000, 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 describes a 510(k) premarket notification for the Intuitive Surgical da Vinci Surgical System and Endowrist Instruments. However, the document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data for a new device.

Therefore, many of the requested items (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size and ground truth establishment) are not explicitly provided in this type of regulatory submission.

The document indicates that the submission is for design modifications to the existing da Vinci Surgical System, primarily affecting the Patient Side Manipulators (PSM), Endoscope Camera Manipulator (ECM), and the Patient Side Cart to enhance ease of use. Minor changes to the Surgeon Console and endoscopic instruments are also noted.

The core of the submission is to prove that these modifications do not alter the fundamental safety and effectiveness of the device compared to its already legally marketed predicate devices.

Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated and what is missing:

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

This information is not explicitly provided in a quantified table format. The document states: "Design analysis and comparison, as well as bench testing and risk analysis activities, have been conducted to confirm that the characteristics of the modified device are substantially equivalent to the predicate devices cited."

This suggests that the "acceptance criteria" were likely related to demonstrating that the modified device's performance (functionality, safety, physical characteristics) was within acceptable parameters or identical to the predicate device, rather than achieving specific performance thresholds for a novel function. The "reported device performance" is essentially that it met the criteria for substantial equivalence.

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 provided. The document mentions "bench testing" but does not specify the sample size of devices, components, or any test data used. The provenance (country of origin, retrospective/prospective) is also not stated.

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 provided. In a substantial equivalence submission for a surgical system's mechanical modifications, "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on medical images) is not the primary focus. The "ground truth" here is more about engineering specifications, device functionality, and safety validated through design analysis and bench testing.

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

This information is not provided. Adjudication methods are typically relevant in studies involving human interpretation or subjective assessments. Here, the assessment seems to be based on objective engineering comparisons and testing.

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

An MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for AI-assisted diagnostic or interpretative devices, which this surgical system is not. The submission is for hardware modifications to a surgical control system.

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

This concept is not applicable to the device described. The da Vinci Surgical System is a human-in-the-loop system by its very nature (a surgeon controls it). The modifications are to the physical components of the system, not a standalone algorithm.

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

The "ground truth" implicitly used for this type of submission would be the established performance and safety characteristics of the predicate device, against which the modified device's characteristics are compared. This is based on engineering specifications, functionality tests, and risk analysis. It does not involve medical "ground truth" like pathology or outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

This information is not provided and is not applicable. This device is a surgical system with physical components and software, not an AI model that requires a "training set" of data in the machine learning sense.

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

This information is not provided and is not applicable for the same reason as above.

Summary of what the document does convey regarding meeting acceptance criteria:

The document states its Conclusion: "Based upon the device's general specifications, intended use, and results of risk analysis and performance testing provided in this pre-market notification, the da Vinci Surgical System described herein has been shown to be substantially equivalent to current legally marketed predicate device."

This indicates that the implicit "acceptance criteria" were met through:

• Design analysis and comparison to predicate devices.
• Bench testing.
• Risk analysis activities.

The core "performance" reported is that the "technology, materials, manufacturing methods, and performance are essentially the same for the predicate device as the subject device," with the primary differences being form factor and electromechanical components for ease of use, but not affecting core operation or functionality.

In essence, for this 510(k) submission for modifications to an existing surgical system, the "acceptance criteria" and "study" are focused on demonstrating that the changes do not negatively impact equivalence to the predicate device, rather than quantifying new performance metrics for a novel technology.

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