(449 days)
The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.
The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a joystick or manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II.
The joystick is linked to related connection of the SOLOASSIST II by a wire. The joystick is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm.
The Tension Sleeve and the Endoscope clamp are loosely screwed together. The combination of Tension Sleeve and Endoscope clamp are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right tension sleeve for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II.
The starting point of the movement for an operation will be saved as the TROCAR POINT. The Universal Joint has to be mounted on the SOLOASSIST II. A mounted Universal Joint can be removed by using the release slider. To define the Trocar point the Universal Joint has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of SOLOASSIST
The Endoscope Clamp (together with Tension Sleeve and Endoscope) is mounted on the Universal Joint, so the SOLOASSIST II is ready for operation.
Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the joystick the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the joystick it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out.
Additionally it is possible to move the arm of the SOLOASSIST II without the use of the iovstick. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system.
To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.
The provided text describes the 510(k) summary for the SOLOASSIST II device. However, it does not contain information about acceptance criteria for particular performance metrics, nor does it detail a study proving the device meets specific performance thresholds in a clinical or human-in-the-loop setting.
The document focuses on non-clinical testing for substantial equivalence, primarily covering:
- Biocompatibility
- Electrical safety and electromagnetic compatibility (EMC)
- Software verification and validation
- Mechanical, acoustic, and bench testing (though these are more about general device robustness and function, not specific performance metrics like speed, accuracy, or image quality that would typically have acceptance criteria for an AI/robotic system controlling an endoscope for image acquisition)
- Cybersecurity risk assessment
- Sterilization
- Human Factors testing (focused on safety and usability, not quantitative performance against acceptance criteria)
- Packaging
Crucially, Section 8.2 states: "No clinical evaluation was conducted for this device." This means there would be no data from a study involving human users or patients to establish performance against acceptance criteria in a real-world or simulated clinical scenario, which is usually where such detailed acceptance criteria for AI-driven assistance systems are measured.
Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria and a study proving quantitative performance against those criteria (especially for AI assistance) is not present in the provided text. The device, SOLOASSIST II, is described as a "robotic computer driven system" that holds and positions an endoscope, but the performance data presented is entirely non-clinical and focused on safety, usability, and basic functional integrity, not AI-driven performance metrics.
If this were an AI-driven system requiring a clinical or human-in-the-loop study with specific performance acceptance criteria, the provided document would be insufficient.
In summary, based only on the provided text, there is no information to construct the requested table or answer the specific questions about acceptance criteria and performance study details related to an AI-driven component (beyond the general "software verification and validation"). The document explicitly states "No clinical evaluation was conducted for this device."
§ 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.