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The Distalmotion Dexter L6 System is intended to assist in the accurate control of endoscopes as well as endoscopic instruments for endoscopic manipulation of tissue, including grasping, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair. The system is indicated for adult uses, as defined as 22 years old and older. It is intended for use by trained laparoscopic surgeons in an operating room environment in accordance with the representative and specific procedures set forth in the Instructions for Use.

The Dexter L6 System is for prescription use only.

The Dexter L6 Surgical System is intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures. The system is comprised of two major elements, the Surgeon Console and the Patient Cart. The surgeon console allows the surgeon to scrub into the surgical field, and either in seated or standing position, allows control of the instrument and endoscope arms on the patient cart. The Surgeon Console provides the surgeon two handle grips and two pedals, one pedal to clutch instrument control and a second to engage endoscope control. The patient cart is a modular element of the system which is comprised of a pedestal and boom which support the instrument arm. The instrument arm on the patient cart is controlled by the Master Arms on the surgeon cart. The Master Arms are passive elements on the surgeon cart which translate the movements of the Instrument arms. A system overview is provided in Figure 1, including surgeon console, patient carts, and endoscope cart. Figure 2 shows end effectors cleared for use on the system. In addition to the major elements of the system certain reusable and disposable sterile accessories are cleared with the Dexter L6 system, shown in figures 3 and 4.

Dexter L6 Surgical System: Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dexter L6 Surgical System, particularly for its clinical performance, are derived from the primary endpoints of the RAS AHEAD Study and comparisons to literature on similar robotic systems.

2. Sample Size and Data Provenance

• Sample Size (Clinical Test Set): 50 adult subjects were "as treated" (at least one procedural step started with the study device) out of 51 enrolled subjects. The target was at least 45 completed subjects for analysis.
• Data Provenance: Prospective, multicenter, open-label clinical investigation (RAS AHEAD Study). The study was conducted at three centers: France (20 subjects), Switzerland (20 subjects), and Germany (10 subjects).

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three investigators (surgeons) participated in the clinical study.
• Qualifications of Experts: All three investigators were general surgeons. Their robotic surgical experience ranged from 9 months to 5 years. They underwent a dedicated training curriculum to ensure safe and effective use of the Dexter System.
  • Surgeon #1: 35 years laparoscopic experience (several thousands of procedures), 17 months RAS experience (46 procedures), 46 Dexter procedures (41 inguinal hernia procedures with Dexter before study start).
  • Surgeon #2: 7 years laparoscopic experience (500 procedures), 9 months RAS experience (67 procedures), 42 Dexter procedures (28 inguinal hernia procedures with Dexter before study start).
  • Surgeon #3: 19 years laparoscopic experience (>2600 procedures), 5 years RAS experience (290 procedures), 38 Dexter procedures (7 inguinal hernia procedures with Dexter before study start).

4. Adjudication Method for the Test Set

• All adverse events reported in the clinical study were reviewed by a Clinical Events Committee (CEC).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was explicitly mentioned in the provided text to evaluate how much human readers (surgeons) improve with AI (robotic assistance) vs. without AI assistance. The clinical study was a single-arm study evaluating the Dexter L6 System's performance rather than a direct comparison of human performance with and without the device in the same clinical scenario.
• However, the clinical performance and safety were compared to literature reporting for "primary unilateral or bilateral inguinal hernia via minimally invasive surgery", prepared by an independent contractor. This literature review focused on comparative devices like Da Vinci and Senhance systems, implicitly serving as a comparative effectiveness assessment against existing robotic and minimally invasive surgical approaches.

6. Standalone Performance Study (Algorithm Only)

• The Dexter L6 Surgical System is an electromechanical surgical system with human-in-the-loop control (surgeon console, patient cart, instrument arms). Therefore, a "standalone" performance study (algorithm only without human-in-the-loop performance) is not applicable or described for this type of device. The extensive bench testing described (System Testing, Accuracy and Precision, Workspace Access, etc.) evaluates the technical performance of the device components and integrated system.

7. Type of Ground Truth Used (Clinical Test Set)

• The clinical performance was evaluated against clinical outcomes data (e.g., procedural success defined as no conversion, occurrence of severe adverse events) and measurements during the surgical procedures (e.g., docking time, operative time, instrument consumption).
• For safety, the ground truth for adverse events was established by direct observation and reporting in the clinical trial, followed by adjudication by a Clinical Events Committee (CEC).

8. Sample Size for the Training Set

• The provided text does not explicitly detail a separate "training set" in the context of an AI/machine learning algorithm, as the device is an electromechanical surgical system controlled by a surgeon.
• However, 639 commercial procedures performed in the EU across various surgical specialties (including 178 inguinal hernia procedures) represent real-world experience contributing to the overall understanding and refinement of the device's operational characteristics, which could be considered analogous to a "training dataset" for broader device understanding and post-market surveillance.
• The three surgeons participating in the clinical study also had previous experience with the Dexter System prior to the study (Surgeon #1: 46 procedures, Surgeon #2: 42 procedures, Surgeon #3: 38 procedures), which served as their individual training.

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

• Given that this is an electromechanical surgical system controlled by human surgeons, there isn't a traditional "ground truth for algorithm training" in the sense of labeled medical images or diagnoses.
• Instead, the "training" for the device, and the basis for establishing its performance, comes from:
  • Extensive non-clinical/bench studies: These tests (biocompatibility, cleaning/sterilization, device integrity/use-life, environmental, EMC, electrical/mechanical/thermal safety, usability, system accuracy, workspace, sub-system testing, thermal effects on tissue) provide a technical "ground truth" for the device's engineering and functional requirements.
  • Surgeon training curriculum: The "ground truth" for effective use is established through structured training programs that ensure surgeons can safely and effectively operate the device, as described in the "TRAINING" section.
  • Accumulated commercial experience: The outcomes of 639 commercial procedures contribute to a real-world understanding of the device's performance, informing future iterations or usage guidelines. The "interim Post-Market Clinic Follow-up (PMCF) study report" implies ongoing data collection for effectiveness and safety.

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The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing.

The Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.

The Versius Surgical System is intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures.

The system comprises (Figure 1):

• . a surgeon console,
• a visualization bedside unit .
• . up to three instrument bedside units
• . surgical attachments comprising an endoscopic camera and surgical instruments,
• . and sterile drapes

Each bedside unit includes a robot arm to which the endoscopic camera and instruments are attached.

This application is for the Versius Surgical System, a robotic surgical device. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It's important to note that the provided text describes validation and verification processes across various aspects (biocompatibility, sterility, electrical safety, software, bench testing, animal testing, human factors, and clinical studies) rather than a single unified "study" with one set of acceptance criteria. The acceptance criteria are largely defined by passing these various tests and achieving specific clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the information, which includes various types of testing (non-clinical, animal, human factors, and clinical trials), I will integrate and summarize the "acceptance criteria" based on the "Results" sections for each type of study, particularly focusing on the clinical effectiveness and safety criteria.

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

• Clinical Studies (Cholecystectomy):
  • Poland Study: 30 subjects.
    • Data Provenance: Prospective, single-center, conducted in Poland.
  • India Study: 30 subjects.
    • Data Provenance: Prospective, single-center, conducted in India.
  • Combined for Suturing: 60 subjects (30 from Poland, 30 from India; total laparoscopic hysterectomy cases).
    • Data Provenance: Prospective, from Poland and India.
• Animal Testing:
  • Cholecystectomy: 3 acute, 3 chronic porcine models (6 animals total).
  • TLH (for suturing indication): 3 chronic, 3 acute porcine models (6 animals total).
  • Data Provenance: Not explicitly stated, but implies laboratory/research setting where GLP requirements were followed.
• Human Factors Testing:
  • US Validation Study: Sixteen surgical teams (number of individuals not specified, but typically includes surgeon + surgical staff).
  • Data Provenance: US-based activity, simulated operating room setting.

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

• Clinical Studies (Cholecystectomy):
  • Poland Study: 3 surgeons.
    • Qualifications: All generalists. Principal investigator: 15 years open surgery experience, no previous robotic surgery experience. Other two surgeons: ~10 years laparoscopic surgery experience, no previous robotic surgery experience.
  • India Study: 1 surgeon.
    • Qualifications: Generalist with >35 years open and laparoscopic surgery experience. Completed >500 cholecystectomy cases using OUS commercially available Versius System.
• Animal Testing: Ground truth was established by evaluation per protocol for overall animal health, test article performance, and local tissue response, likely by veterinary pathologists and study investigators. Specific numbers and qualifications of these experts are not provided.
• Human Factors Testing: "Intended users" were involved, including surgical teams. Specific qualifications beyond "surgeon" and "remainder of the surgical team" are not provided. The evaluation for "no pattern of use error" would implicitly involve human factors experts or trained evaluators.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the clinical outcomes or other testing results. The clinical studies describe outcomes based on the study protocol, and any "conversions" or "adverse events" are reported as observed by the investigators. For bench and animal testing, the results are simply stated as "PASS" based on expert evaluation or predefined criteria.

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

No MRMC comparative effectiveness study was done regarding human reader improvement with AI assistance. The Versius Surgical System is a robotic surgical device for performing procedures, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve human "readers." The focus is on the device's performance in surgical execution.

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

The device itself (the robotic system) operates under the control of a human surgeon. Therefore, a "standalone" performance without "human-in-the-loop performance" is not applicable in the context of the device's primary function in assisting surgery. The "standalone" bench tests demonstrate the system's inherent functional capabilities (e.g., motion accuracy, latency, component integrity) independent of surgeon interaction for some tests, but for surgical task performance (the indications for use), human interaction is fundamental.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Clinical Studies (Cholecystectomy & Suturing): Ground truth was primarily clinical outcomes data, including:
  • Rate of unplanned conversion (primary effectiveness).
  • Rate of intraoperative and postoperative serious adverse events (primary safety).
  • Operative time, estimated blood loss, complications, hospital stay, readmission, reoperation, mortality, histopathology of removed specimen, device deficiencies, etc. (secondary endpoints).
  • For suturing, vaginal vault dehiscence at 42 days was the key outcome.
  • These are based on standard medical practice and follow-up.
• Animal Testing: Ground truth was based on animal health endpoints, test article performance, and local tissue response, likely determined through direct observation, physiological monitoring, and histopathology/gross examination of affected organs and surrounding tissue.
• Non-Clinical Bench Testing: Ground truth was established by adherence to pre-defined acceptance criteria against established engineering and safety standards (e.g., specific thresholds for motion accuracy, latency within acceptable range, stability criteria, pass/fail for biocompatibility and sterility tests).
• Human Factors Testing: Ground truth was the observation of tasks completion by surgical teams without a "pattern of use error or difficulties," judged by human factors experts and study evaluators against criteria for safe and effective interaction.

8. The Sample Size for the Training Set

The document does not explicitly provide information on a "training set" for an algorithm or AI model in the typical sense. The provided context describes verification and validation of a physical surgical system. "Training" refers to:

• Surgical Training: The sponsor developed a "Versius-specific use training program" for human users (surgeons and surgical teams). This is training for the human operators, not a data set to train an algorithm. There's no specific sample size for this human training program mentioned as a statistical "training set."
• Software Development: While software verification and validation (V&V) occurred, details about specific data sets used for training any internal algorithms (e.g., control algorithms) are not provided. The phrase "training set" is usually reserved for machine learning contexts, which isn't the primary focus here.

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

As there is no explicit "training set" for an AI algorithm mentioned, this question is not fully applicable. However, for the human training, the "ground truth" for proper device use is established by adherence to documented procedures, instructions for use, and safe practices defined by the manufacturer and medical standards, which are then reinforced and assessed through the training program and human factors validation.

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