(315 days)
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.
| Acceptance Criteria (Derived from Study Protocol / Literature Comparison) | Reported Device Performance (RAS AHEAD Study) |
|---|---|
| Primary Safety: | |
| Zero occurrence of serious (Clavien-Dindo grades III-V) device-related adverse events perioperatively up to 30 days. | PASS: Zero postoperative serious (Clavien-Dindo grades III-V) device-related adverse events perioperatively up to 30 days. CEC review confirmed no endpoint-related events. |
| Primary Performance: | |
| Procedural success, defined as successful completion of the Dexter-assisted procedure without conversion to an open or fully laparoscopic surgical approach, with a rate within 10% (defined in study protocol). | PASS: 49 of 50 procedures (98.0%) successfully completed without conversion to an open or fully laparoscopic surgical approach. |
| Secondary Performance (Operative Time): | |
| Mean operative times (skin incision to skin suturing) comparable to literature (60-100 minutes) for inguinal hernia repair. | PASS: Mean operative time was 54.5 min for unilateral procedures and 94.6 min for bilateral procedures (in line with literature). |
| Secondary Safety (Complications): | |
| Low rates of intraoperative (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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