(49 days)
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 and 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. The movement of the laparoscope may be controlled as a simple joystick, enabling movements to up/down, left/right, zoom out directions or be guided by the movement of a designated tool within the field of view, enabling movement in oblique trajectories. Additionally, the system enables the surgeon to manually perform larger movements of the laparoscope using the Manual Activation Button affixed to the AutoLap system.
The provided text describes a 510(k) premarket notification for the AutoLap System, a device designed to hold and control the movement of a laparoscope during minimally invasive surgery. It details performance testing conducted but does not specify acceptance criteria in a quantitative table or the details of a study that directly proves the device meets such criteria for diagnostic accuracy or clinical effectiveness in the way an AI diagnostic device typically would.
However, based on the provided text, here's an attempt to structure the information according to your request, with the understanding that many specific details you asked for (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies) are not present in this type of FDA document for a device primarily focused on mechanical assistance.
Overview of the Device and Study Purpose:
The AutoLap System is a robotic laparoscope holder and controller. The premarket notification (K152848) is for a modified version of an already cleared device, with the primary changes being an added mode of movement control (guided by a designated tool within the field of view) and the ability to connect a separate monitor for parallel display. The "study" described is a series of performance tests to demonstrate the safety and effectiveness of the modified device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in the format of a table with specific thresholds for sensitivity, specificity, accuracy, or similar metrics typically associated with AI diagnostic devices. Instead, the performance evaluation for this robotic system focuses on safety, functionality, and meeting engineering specifications.
| Acceptance Criterion Category | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Device tested in accordance with ANSI/AAMI 60601-1:2005. |
| Electromagnetic Compatibility (EMC) | Device tested in accordance with IEC 60601-1-2:2007. |
| Bench Testing - Image Stability | Evaluated and demonstrated acceptable stability. |
| Bench Testing - Image Processing, System Functionality, and Performance to Move Camera | Evaluated and demonstrated system's ability to move the camera to the requested position using different modes of operation. |
| Bench Testing - Connection, Receipt, and Display of Video | Evaluated and demonstrated proper connection and display on a separate monitor. |
| Animal Testing - New Movement Control Mode | Demonstrated the performance of the added mode of movement control. |
Overall Conclusion of Performance Testing: "All performance testing demonstrates that the modified AutoLap System performs according to specifications and functions as intended."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document refers to "bench testing" and "animal testing" but does not quantify the number of tests performed or the number of animal subjects.
- Data Provenance: The device manufacturer, M.S.T. Medical Surgery Technologies Ltd., is located in Israel. The testing was conducted to evaluate the modified device. It is implied these were prospective tests specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the document. The type of device (robotic laparoscope holder) and the nature of the testing (electrical, EMC, bench, animal for functionality) do not typically involve human experts establishing diagnostic "ground truth" for a test set in the way an AI diagnostic algorithm would. The "ground truth" for these tests would be objective measurements and observations of the device's physical and electronic performance against engineering specifications.
4. Adjudication Method for the Test Set
Not applicable and not specified. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data to establish ground truth from multiple readers. This device's testing did not involve such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not performed.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is a robotic surgical assistant, not an AI diagnostic tool designed to assist human readers in image interpretation. The device assists the surgeon by holding and moving the laparoscope, thereby potentially freeing up a human assistant or improving camera stability, but its performance isn't measured in terms of improving human reader diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? The "bench testing" and "animal testing" represent the closest equivalent to a standalone performance evaluation, as they assess the device's intrinsic mechanical and algorithmic capabilities. The description of these tests ("Image stability," "Image processing, system functionality, and performance to move the camera," "performance of the added mode of movement control") focuses on the device's direct output and function. However, it's not a standalone diagnostic performance study as would be conducted for an AI image analysis tool.
7. Type of Ground Truth Used
The "ground truth" for the tests performed was based on:
- Compliance with recognized electrical safety and EMC standards (ANSI/AAMI 60601-1:2005, IEC 60601-1-2:2007).
- Engineering specifications for image stability, system functionality, camera movement, and video display connection.
- Observed functional performance in an animal model for the new mode of movement control.
This is fundamentally different from ground truth derived from pathology, expert consensus, or outcomes data, which are typical for diagnostic imaging AI.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The AutoLap System is a robotic device with integrated software and hardware. The document describes modifications to an existing device and its performance testing, but it does not refer to a machine learning model that requires a distinct "training set" in the conventional sense of AI development for diagnostic tasks. Its "training" is more akin to traditional software development and calibration processes, which are not quantified in typical dataset terms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" with associated "ground truth" in the context of machine learning model training described for this device. The software algorithms and controls are likely developed and validated through engineering principles and testing against defined operational specifications rather than through supervised learning with labeled data.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.