Search Results

The AutoLap System is indicated for General laparoscopic, Gynecologic and Urologic procedures for the purpose of holding and controlling the movement of a standard laparoscope or rigid endoscope within surgical cavities during minimally invasive laparoscopic surgery.

The AutoLap System is designed to hold and control the movement of a laparoscope or rigid endoscope during laparoscopic procedures. The AutoLap System includes both software and hardware. Hardware components include a Processing Unit, which includes the system's electronics and software algorithms, a Base Unit and a Laparoscopic Unit that include motors and sensors. The Base Unit is mounted on the operating bed. An accessory cart that is used for placing the system's components during the procedure and their storage afterwards is also provided. To maneuver the laparoscope to the desired position, the surgeon presses a single button, referred to as Command Unit, which is affixed to his/her hand or to the surgical instrument and transmits RF signals to the system. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system. Movements can be performed in the left/right, up/down and zoom in/ zoom out directions.

This submission (K131375) describes the MST AutoLap System, a device designed to hold and control the movement of a laparoscope or rigid endoscope during minimally invasive laparoscopic surgery. The performance evaluation for this device primarily focuses on demonstrating its safety and meeting functional specifications, rather than clinical efficacy studies often seen with diagnostic AI.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The primary "test set" that involves a direct assessment of device functionality in a surgical context is described as an "animal study."
• Sample Size: Not explicitly stated as a number of animals (e.g., "5 pigs"), but refers to "domestic pigs" for "laparoscopic cholecystectomy and Nissen fundoplication."
• Data Provenance: Not specified, but implied to be prospective data collected specifically for this study during the animal procedures. Country of origin not stated.

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

• Number of Experts: "Several surgeons" performed the procedures in the animal study.
• Qualifications of Experts: Not specified. It can be presumed they are experienced surgeons performing these types of laparoscopic procedures. However, no details on their specific qualifications (e.g., years of experience, board certification) are provided.

4. Adjudication Method for the Test Set

The concept of "adjudication" (e.g., 2+1, 3+1) is typically associated with studies where multiple readers or experts independently assess cases and their agreement or disagreement needs to be resolved to establish ground truth outcomes.

In this context, for the animal study:

• Adjudication Method: Not applicable/not described in the traditional sense. The "ground truth" for complications and performance appears to be established directly by the "several surgeons" performing the procedures, likely based on their real-time observation and expert judgment during the surgeries. There's no mention of independent review or formal adjudication of findings after the fact by a separate panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described. The animal study focused on observing the device's performance and safety during procedures, not on comparing surgeon performance with and without the AI (or automated assistance in this case) on multiple cases with multiple readers. There's no mention of an effect size for human reader improvement with AI assistance. This device is not primarily an "AI diagnostic assistance" tool but rather a robotic/automated surgical assistant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Standalone Performance: Not explicitly described as a standalone study for the entire system's clinical performance. The "bench testing" represents a form of standalone testing for the device's functional parameters (movement velocities, range, control, image stability, safety features) without a human-in-the-loop during that specific test. However, this isn't assessing the device's diagnostic or surgical outcome capability as a standalone AI, but rather its electromechanical adherence to specifications. The system is designed to be a human-in-the-loop assistant, so a true "algorithm only" clinical performance assessment wouldn't be directly applicable to its intended use.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for bench testing (e.g., movement velocities, range, safety features) would be the device's engineering specifications and physical measurements obtained from sensors or external measurement tools.
• Animal Study: The ground truth for the animal study was based on direct observation and expert judgment by the surgeons performing the procedures regarding the device's performance (movement control) and the occurrence (or absence) of operative complications related to its use. This is a form of expert consensus/clinical observation.

8. The Sample Size for the Training Set

The provided text does not contain any information about a specific "training set" or "sample size for training." This device is more of a robotic system with embedded software algorithms than a machine learning or AI algorithm that requires a separate, large training dataset to learn patterns from data. Its software likely relies on predefined control algorithms rather than adaptive learning from a dataset.

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

Since no training set is described in the provided information, there is no information on how ground truth for a training set was established.

Ask a specific question about this device