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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.

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

• Sample Size: Not explicitly stated for each test. For reliability testing, it mentions "Single-Site Ports were tested" but doesn't provide a number. For design validation, it says "The Single Site Port was placed into the abdominal wall in a porcine model," implying a limited number of models.
• Data Provenance:
  • Biocompatibility: Performed by a "third-party lab."
  • Bench (Physical, Equipment Interface, Reliability): Performed by the manufacturer (Intuitive Surgical, Inc.).
  • Animal (Design Validation): Porcine model.
  • All data appears to be prospective as it was generated specifically for this 510(k) submission to demonstrate the equivalence of the modified device.
  • Country of origin: Not explicitly stated for the third-party lab for biocompatibility. Bench and animal testing would presumably be conducted in the US by the manufacturer (Sunnyvale, CA).

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

• For the technical and bench tests (physical, equipment interface, reliability), "ground truth" is defined by the device's design specifications and performance metrics, which are established by the manufacturer's engineering and quality teams. No external experts are mentioned for establishing ground truth for these tests.
• For the animal model, the assessment of safety and effectiveness (e.g., effect on tissue) would have been conducted by specialists involved in animal studies, likely veterinary professionals or surgeons. No specific number or qualifications are provided in the document.

4. Adjudication Method for the Test Set:

• Not applicable as the tests described are primarily objective measurements (e.g., dimensions, hardness, insufflation pressure, wear resistance) or biological assessments (biocompatibility, tissue reaction in animal model). There is no mention of subjective assessments requiring adjudication or consensus among multiple reviewers.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a material change in a surgical port, not a diagnostic or AI-assisted system that would typically warrant such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No, a standalone (algorithm only) performance study was not done. This device is a passive surgical accessory (port), not an algorithm or an AI system.

7. The Type of Ground Truth Used:

• Bench Testing (Physical, Equipment Interface, Reliability): Ground truth is based on design specifications and performance requirements established by the manufacturer, often derived from industry standards and internal engineering targets.
• Biocompatibility: Ground truth is established by international standards (ISO 10993) and FDA guidance documents, with testing conducted to evaluate compliance against these established biological safety benchmarks.
• Design Validation (Animal Model): Ground truth relates to observable biological effects and functional performance in a live tissue environment, assessed by researchers/veterinary staff against expected normal physiological responses and proper device function.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical surgical accessory and does not involve AI/machine learning, so there is no "training set."

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

• Not applicable, as there is no training set for this type of device.

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