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Indications for Use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two models, one for ABF01-F and the other for lock functions, ABF01-L. The two models are same except for lock function. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The document describes the ArtiSential Bipolar Fenestrated Forceps, a single-use electrosurgical instrument used in laparoscopic surgery for coagulation, dissection, and grasping of tissue. The device underwent several performance tests to demonstrate its safety and effectiveness and establish substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance tests. The data provenance is also not specified; however, given the applicant's address (Republic of Korea) and the FDA submission, it is likely that the testing data was generated in support of regulatory approval in the US. The nature of the tests (physical, electrical, and biocompatibility) suggests that they are laboratory-based and generally not dependent on patient data provenance.

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

This information is not applicable. The performance tests described are objective, engineering-based evaluations of the device's physical and electrical characteristics, and biological safety. They do not involve expert interpretation or ground truth derived from a clinical dataset (e.g., medical images).

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective and do not involve human interpretation requiring adjudication.

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

Not applicable. The ArtiSential Bipolar Fenestrated Forceps is a medical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable, as this is a medical instrument and not an algorithm. Performance tests mentioned are for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on objective, measurable engineering specifications, established international standards (e.g., ISO 10993-1, IEC 60601 series, ISO-11135), and visual inspection criteria. It is not dependent on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. There is no training set for this type of device.

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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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Indications For Use - da Vinci Connect:

The da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000.

Indications For Use - da Vinci OnSite:

The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.

The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and da Vinci OnSite, is a minor modification to the existing computer assisted device designed to facilitate complex surgery using minimally invasive approach. An overview of the IS2000 consists of the following three main integrated sub-systems: The Surgeon Console, Model SS2000: The control center of the surgical system, and allows the surgeon to control critical aspects of the surgical procedure (including movement of the endoscopic instruments and endoscope). Instrument and camera movements are controlled by the Master Tool Manipulators (MTM), two hand operated controllers, and foot pedals at the Surgeon Console's base. These allow the surgeon to be as dexterous as in "open" surgery. while operating in a minimally invasive environment. The surgeon has the option to change the surgical view from full screen mode to a multi-image mode, which displays an optional 3- dimensional High Definition (3-D HD), 3-D, or 2-D standard definition image of the operative field.

The Patient Side Cart (PSC, Model PS2000): The operative component of the surgical system within the sterile field. Its primary function is to support the endoscopic instrument arms and camera arm, during surgical procedures. Endoscopic instruments are held in a fixed position (with respect to the patient) by unique Patient Side Manipulators (PSM), and the endoscope is held by the Endoscope Camera Manipulator (ECM). The PSM's and ECM are attached to surgical arms on the PSC known as Set-up Joint (SUJ) arms. Commands from the Surgeon Console are relayed to the PSC, via a cable.

InSite ® Vision System (Model VS2000): Houses the system's image processing equipment and is operated by a person outside the sterile field during surgery. The cart provides space for an optional touch screen monitor, as well as ancillary surgical equipment. The VS2000 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 image (or alternatively a 2-D) of the surgical field for the surgeon's reference.

The provided text describes a 510(k) submission for the Intuitive Surgical da Vinci S Surgical System, Model IS2000, with da Vinci Connect™ and da Vinci OnSite™. This submission is a request for clearance for minor modifications to an existing device, not a new device requiring extensive clinical trials to establish de novo safety and effectiveness.

Therefore, the information typically associated with acceptance criteria and studies proving the device meets those criteria (such as detailed performance metrics, sample sizes for training/test sets, ground truth establishment, or specific study designs like MRMC or standalone performance) is not present in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to establishing new safety and effectiveness for a novel device.

The study presented is a comparison to predicate device and a performance design analysis to demonstrate substantial equivalence, rather than a clinical study with detailed performance metrics against acceptance criteria.

Here's an analysis based on the information provided, highlighting what is available and what is explicitly not available or applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria and Performance: For this 510(k) submission, the "acceptance criteria" are predominantly framed around demonstrating substantial equivalence to an already legally marketed predicate device. This means the primary "performance" reported is the demonstration that the modified device performs as intended and is as safe and effective as the predicate, without introducing new risks. Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific tolerances) for the new functionalities (Connect and OnSite) are not detailed in this summary, as the modifications are described as "minor" and primarily involve communication and diagnostics.

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

• Sample Size for Test Set: Not applicable/Not provided. This submission is for a modification to an existing surgical system, not a diagnostic device requiring a "test set" of patient data for performance evaluation in the typical sense. The "studies" conducted were design analysis, bench testing, and risk analysis.
• Data Provenance: Not applicable/Not provided. No patient or clinical data sets are mentioned or used in this summary. The evaluation is based on design, engineering analysis, and bench testing.

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

• Not applicable/Not provided. No "ground truth" for patient data was established, as this was not a clinical or diagnostic performance study on patient cases. The evaluation concerned the engineering and functional equivalence of hardware and software modifications.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. As there was no test set of patient data, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No. An MRMC study was not done. These studies are typically for evaluating the impact of a new diagnostic technology on human reader performance, which is not the scope of this submission. The "da Vinci Connect" allows a proctor to provide advice, but this submission does not contain a study quantitatively measuring the effect size of this assistance on surgical outcomes or human reader performance.

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

• Not applicable/Not provided. This is not an AI or algorithm-only device. The "da Vinci Connect" is an accessory for human proctors to communicate and advise, and "da Vinci OnSite" is for customer service personnel to diagnose system faults. Neither is a standalone algorithm whose performance would be independently assessed in this manner.

7. The Type of Ground Truth Used

• Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) doesn't apply to this submission, as it's not a diagnostic or treatment outcome-measuring device in the context of this modification. The "ground truth" for the engineering performance and safety would be the established specifications and safety profiles of the predicate device, against which the modifications were compared through design analysis and bench testing.

8. The Sample Size for the Training Set

• Not applicable/Not provided. There is no "training set" in the context of machine learning for this device submission.

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

• Not applicable/Not provided. As there was no training set for machine learning, this information is not relevant to the submission.

Summary Conclusion for this Submission:

This 510(k) submission for the da Vinci S Surgical System with da Vinci Connect and da Vinci OnSite is a request for clearance based on substantial equivalence to existing predicate devices. The modifications are described as "minor hardware modifications" to support new communication and diagnostic features.

The "study" or evidence presented for FDA clearance relies on:

• Design analysis and comparison: Demonstrating that the modified components function as intended and do not alter the core safety or effectiveness of the surgical system.
• Bench testing: Verifying the performance of the new components and their integration.
• Risk analysis activities: Ensuring that the modifications do not introduce new, unacceptable risks.

The document explicitly states that the device "does not raise any new safety or effectiveness issues" and that its "indications for use remains unchanged from the predicate device" (for the core system). The new functionalities (Connect and OnSite) have their own stated intended uses, but their acceptance is based on demonstrating that they function correctly and safely within the existing system, rather than through complex clinical performance studies with patient data.

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