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The Intuitive Surgical® da Vinci® Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (153000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery, and suturing during single incision laparoscopic cholecystectomy, benign hysterectorny and salpingo- oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port.

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site Port (with insufflation adapter and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.

The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clipligation, electrocautery, and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).

This submission pertains to a modification of the Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories, specifically a change in the material formulation of the Single-Site Port. The core of the submission argues for substantial equivalence to the predicate device due to this material change.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values for all tests. Instead, it describes general categories of verification and validation testing, with the implicit acceptance criterion being that the new material formulation performs equivalently to the predicate.

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