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The Intuitive Surgical® Endoscopic Instrument Control System (hereinafter referred to as the " da Vinci® System") 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. 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.

Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

This special 510(k) is being submitted for a modification of Intuitive Surgical® Endoscopic Instruments to include the EndoPass Endoscopic Delivery Instrument. The EndoPass Endoscopic Delivery Instrument is similar to the Clip Applier instrument originally cleared by FDA in 2000 (K990144).

The EndoPass Endoscopic Delivery Instrument is used with the Intuitive Surgical® Endoscopic Instrument Control System, also known as the da Vinci Surgical System. The da Vinci Surgical Systemconsists 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 describes a 510(k) premarket notification for a medical device called the "EndoPass Endoscopic Delivery Instrument." This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device evaluations.

Therefore, many of the requested details, such as specific acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, and effect sizes of AI assistance, are not applicable or not provided in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This submission does not describe a clinical study or a test set in the context of AI/ML performance evaluation. The "testing" mentioned is in vitro testing for functional characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. Ground truth, in the context of expert consensus for AI/ML validation, is not relevant to this submission. The evaluation is based on engineering design analysis and in vitro functional testing.

4. Adjudication method for the test set:

• Not applicable / Not provided. No test set requiring expert adjudication is described.

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:

• No. This is not an AI/ML device, and no MRMC study or human-in-the-loop performance evaluation is described. The device is a surgical instrument.

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

• Not applicable. This device is a physical surgical instrument, not an algorithm.

7. The type of ground truth used:

• Not applicable / Not provided in the AI/ML sense. The "ground truth" for this submission is the performance and characteristics of the legally marketed predicate device, against which the new device's functional equivalence and safety are compared, primarily through design analysis and in vitro testing.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device, so there is no training set.

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, there is no need to establish ground truth for it.

Summary of the Study:

The "study" described in K040948 is not a clinical trial or an AI/ML performance evaluation. It is a special 510(k) submission for a modification to an existing device (Endoscopic Instruments) to include a new component (EndoPass Endoscopic Delivery Instrument).

The study relies on:

• Design analysis and comparison: A detailed comparison of the new EndoPass instrument's design, shape, function, activation, and use against the predicate device (a clip applier).
• In vitro testing: Functional characteristics were evaluated in vitro to confirm substantial equivalence to the predicate device and that the design output met design input requirements.

The primary objective was to demonstrate substantial equivalence to an already legally marketed predicate device (K990144) as mandated by the 510(k) process for Class II medical devices.

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