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The Intuitive Surgical Endoscopic Instrument Control 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical 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.

The EndoWrist 5mm Thoracic Grasper is intended for endoscopic manipulation of tissue, including grasping, retraction, blunt dissection and approximation.

The EndoWrist 5mm Thoracic Grasper is an endoscopic instrument for use with the Intuitive Surgical da Vinci S Surgical System (K050369) or da Vinci Si Surgical System (K081137). The instrument is designed for atraumatic grasping, manipulation and blunt dissection of tissue while fitting through a 5mm instrument cannula. The EndoWrist 5mm Thoracic Grasper is re-usable, provided non-sterile, and must be cleaned and sterilized using prevacuum autoclave before use. The instrument is programmed for a limited number of uses to ensure reliability and consistent performance. The sterilized instrument is connected to the manipulator arm of the da Vinci Surgical System and the distal tip and shaft of the instrument are inserted through a cannula placed through the body wall of the patient.

This document describes the regulatory approval for the Intuitive Surgical EndoWrist 5mm Thoracic Grasper, a surgical instrument. The content focuses on demonstrating substantial equivalence to a predicate device and provides details about the testing performed.

Please note: The provided document is a 510(k) summary for a surgical instrument, not an AI/ML device. Therefore, the questions related to AI/ML specific concepts like multi-reader multi-case (MRMC) studies, ground truth establishment for training sets, or human-in-the-loop performance are not directly applicable or addressed in this document. The "device" in this context refers to the physical surgical grasper.

Here's an interpretation of the document's content in response to your questions, focusing on the device (the grasper) rather than AI:

Acceptance Criteria and Device Performance (for the EndoWrist 5mm Thoracic Grasper)

The document does not present a formal table of acceptance criteria with reported quantitative performance metrics in the format you requested for an AI/ML device. Instead, it describes compliance with various physical and functional requirements. The acceptance criteria are implicitly those established through design input requirements and are met if the device functions as intended and safely.

Here's a conceptual representation based on the provided text, adapted for a physical device:

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Sizes Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not provide specific numerical sample sizes (e.g., number of instruments tested or number of animal/cadaver subjects). It broadly states "a series of bench tests" and "a canine model (in vivo) and cadavers."
   • Data Provenance:
     • Country of Origin: Not specified, but given the FDA submission, likely studies conducted in adherence to US or international standards, and potentially in the US.
     • Retrospective or Prospective: The testing described (bench testing, animal/cadaver testing for performance verification and validation) is inherently prospective. These are tests specifically designed and conducted to evaluate the performance of the device.

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

   • This question is not directly applicable as the "ground truth" for a physical surgical instrument's performance is typically established by direct measurement against engineering specifications and functional output. For the animal/cadaver testing, the "experts" would be the veterinarians, surgeons, or researchers conducting and observing the procedures to assess performance, but their number and specific qualifications are not detailed beyond "trained physicians."

3. Adjudication Method for the Test Set:

   • Not applicable in the context of a physical surgical instrument's performance testing described here. Adjudication methods like 2+1 or 3+1 are common in diagnostic imaging studies where subjective interpretations are involved. The performance of this instrument is assessed by objective measurements (bench testing) and direct observation of functionality and tissue interaction (animal/cadaver).

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating the impact of an AI diagnostic aid on human reader performance, which is not relevant for a manually operated surgical instrument. The comparison is primarily against a predicate device's design and performance profiles.

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

   • This question is not applicable. The device (EndoWrist 5mm Thoracic Grasper) is a physical surgical instrument, not an algorithm. Its performance is always in conjunction with a human surgeon operating the da Vinci Surgical System.

6. The Type of Ground Truth Used:

   • For bench testing: The "ground truth" is the predefined engineering specifications and design input requirements (e.g., specific dimensions, force thresholds, range of motion limits). Compliance is measured directly.
   • For animal/cadaver testing: The "ground truth" is direct observation of the device's functional performance in a simulated surgical environment (e.g., successful grasping, blunt dissection without tissue trauma, maintenance of insufflation, compatibility with the system). This is based on expert observation and clinical assessment of expected outcomes.

7. The Sample Size for the Training Set:

   • This concept is not applicable as this is a physical medical device (surgical grasper), not an AI/ML algorithm. There is no "training set" in the sense of data used to train a machine learning model. The "training" in the context of device development would refer to the iterative design, prototyping, and internal testing phases, but not a data-driven training set for an algorithm.

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

   • Not applicable (see point 7).

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