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510(k) Data Aggregation
(102 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, suturing, dissecting, coagulating and cutting, with or without high frequency functionality. The Distalmotion Dexter L6 System is intended for use in laparoscopic inguinal hernia repair and cholecystectomy. The system is indicated for adult use, defined as 22 years old and older. It is intended for use by trained laparoscopic or robotic 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 designed to enable complex surgery using a minimally invasive approach. It is composed of the Robot, the single-use accessories, fully articulated instruments, as well as reusable accessories. The Dexter L6 System is compatible with standard single-use laparoscopic trocars measuring 10 [mm] in diameter and larger.
The Robot consists of a Surgeon Console, with which the surgeon controls the movement of the instruments and of the Endoscope Arm using two Handle Grips (reusable), a Clutching Foot Pedal and an Endoscope Foot Pedal; two Patient Carts positioned at the operating room table in which the instruments are inserted and removed through the Hub during surgery; and the Dexter L6 Software installed in the Robot firmware.
The single-use, sterile instruments consist of the Needle Holder, Bipolar Johann Grasper, Bipolar Maryland Dissector, Monopolar Scissors, and Monopolar Hook.
The single-use accessories consist of the Sterile Interface, Endoscope Arm and Sterile Drapes.
The reusable accessories consist of the Accessory tray, Incision Pointer, Emergency Release Tool and Handle Grips.
This document is a 510(k) clearance letter for the Distalmotion Dexter L6 System, expanding its indications for use to include cholecystectomy procedures. The previous clearance (DEN230084) covered laparoscopic inguinal hernia repair.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the expanded indication of cholecystectomy is the successful completion of the Dexter-assisted procedure without conversion to an open or fully laparoscopic surgical approach. The safety is assessed by reporting adverse events.
| Acceptance Criteria Category | Specific Metric | Acceptance Criterion / Goal | Reported Device Performance (NEST Study) |
|---|---|---|---|
| Effectiveness (Primary Endpoint) | Successful completion of Dexter-assisted surgery without conversion to open or fully laparoscopic approach | High success rate | 98.0% (50/51 subjects, 95% CI: 89.6%, 100.0%) |
| Safety (Primary Endpoint) | Postoperative adverse events (Clavien-Dindo grades III-V) perioperatively up to 30 days | Low incidence of severe adverse events | 1 postoperative (Clavien-Dindo grades III-V) adverse event |
| Safety | Serious Adverse Events (SAEs) | Low incidence | 2 serious adverse events (4.0%) |
| Safety | Intraoperative Adverse Events | Low incidence | 2 intraoperative adverse events (4.0%) |
| Safety | Reoperation rate | Low incidence | None of the subjects required reoperation |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 51 subjects (mITT population)
- Data Provenance: Prospective, multicenter, open-label clinical investigation. The document mentions "patient privacy regulations in France" when discussing ethnicity, implying that at least some of the data originates from Europe (specifically France). It also compares the NEST cohort with "EU Literature" and "US Literature" for demographic and comorbidity comparison, suggesting the study itself might have collected data from multiple regions, with specific mention of France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their qualifications. The "ground truth" in this context is the successful completion of the surgical procedure and the occurrence and grading of adverse events. These are typically determined by the operating surgeons and medical staff involved in the patient's care and follow-up, which would then be compiled and reviewed by the study investigators.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. For clinical trials like the NEST study, adverse events and surgical outcomes are usually documented by the clinical site and then centrally reviewed by a clinical events committee (CEC) or similar body. However, the specific method (e.g., 2+1, 3+1 consensus) is not detailed here.
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. The NEST study focused on the performance of the Dexter L6 System in cholecystectomy, where the "reader" would be the surgeon using the system. It was a study on the device's performance, not a comparative study against human readers (surgeons) without the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Dexter L6 System is an "electromechanical surgical system" intended to "assist in the accurate control of endoscopes as well as endoscopic instruments." It is a robotic-assisted surgical system, meaning it inherently involves a human surgeon (the "operator" or "human-in-the-loop") controlling the robot. Therefore, a standalone (algorithm only) performance study would not be applicable or relevant for this type of device. The study evaluates the system's performance with the surgeon.
7. The Type of Ground Truth Used
The ground truth used for the effectiveness endpoint was surgical outcome data (successful completion of the surgery without conversion). For safety, the ground truth was clinical outcomes data (adverse events, their severity (Clavien-Dindo grades), and resolution status), which rely on clinical assessment and diagnosis.
8. The Sample Size for the Training Set
The document does not provide information on a specific training set sample size. This is a clinical study for a hardware device with an expanded indication, not typically a machine learning algorithm that requires a "training set" in the conventional sense for its "performance." The device itself (Dexter L6 System) was previously cleared, and "Extensive bench testing was conducted on the previously cleared Dexter L6 System." This bench testing likely served as a form of "training" or development/verification data, but it's not a "training set" for a diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of an algorithm with associated ground truth is not explicitly mentioned or applicable in the way it would be for AI/ML software. The "ground truth" for the device's initial development and bench testing would have been established through engineering specifications, design verification, and validation activities, ensuring the device performs according to its intended design.
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(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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