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The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the 4rth arm da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.

The Intuitive Surgical EndoWrist Stabilizer is used with the da Vinci Surgical System Model IS2000, which is also known as the da Vinci® STM Surgical System. The surgeon sits at a Surgeon Console and controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope, within the operative field through use of the Master Tool Manipulators (MTM), two hand operated mechanisms residing within the Surgeon Console. The EndoWrist Stabilizer is operated in the same way as other Intuitive Surgical EndoWrist Instruments, and the surgeon "locks" the stabilizer in position by switching MTM control away from the arm holding the stabilizer instrument by tapping a foot pedal on the Surgeon Console.

The Intuitive Surgical EndoWrist Stabilizer is a multiple use instrument similar to existing EndoWrist instruments and has the following key features:

• The EndoWrist Stabilizer incorporates collapsible "pods" as grips that provide . suction based tissue stabilization. The collapsible feature allows the instrument to be used through a 12mm thoracic port.
• . A disposable, pre-packaged sterilized tubing assembly known as "ClearField" tubing is used to connect the instrument to pressurized irrigation fluid to irrigate the surgical site reducing the amount of blood on the stabilized tissue.
• . A disposable, pre-packaged sterilized tubing assembly known as "CardioVac" tubing provides vacuum suction to the stabilizer pods from the Vacuum Source tubing described below.
• . A disposable, pre-packaged sterilized tubing assembly known as "Vacuum Source" tubing that connects the CardioVac tubing to a canister with a four-meter vacuum hose, and also includes a two-meter vacuum hose (with filter) to connect to a regulated vacuum source.

My apologies, but this document does not contain the type of information needed to answer your request.

The provided document is a 510(k) summary for a medical device (da Vinci Surgical System and EndoWrist Stabilizer). It describes the device, its indications for use, and a claim of substantial equivalence to predicate devices, particularly focusing on the removal of a warning against "beating heart procedures."

The key reason I cannot answer your request is stated explicitly in the document:

"Performance Data: Since the subject devices are identical to the predicate devices and no design changes were implemented, performance testing was not required."

This means there was no new study conducted for this specific 510(k) submission to prove the device met acceptance criteria related to its performance. Instead, the submission relies on the substantial equivalence to previously cleared predicate devices and the accumulated clinical experience with the da Vinci S Surgical System in beating heart procedures to justify the removal of the warning.

Therefore, the document does not contain:

1. A table of acceptance criteria and reported device performance: No new performance data was generated for this submission.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, or training set details: These details relate to a performance study, which was explicitly stated as "not required" for this submission.

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