(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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