(300 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, manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II or using the VOICE CONTROL.
The JOYSTICK or the VOICE CONTROL is linked to related connection of the SOLOASSIST II by 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 the SOLOASSIST II.
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 JOYSTICK. 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.
Additionally it is possible to move the arm of the SOLOASSIST II with the use of the VOICE CONTROL. Therefore the user has to put the headset on his head that is connected to the VOICE CONTROL by a Bluetooth-Donqle. The VOICE CONTROL is activated by using the hotword "SOLO". The SOLOASSIST II moves by using predefined Movement Commands.
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 document is a 510(k) summary for the AKTORmed SOLOASSIST II, including its Voice Control accessory. It describes the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to a predicate device.
However, the document does not contain the level of detail typically found in a clinical study report that would specify "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy, sensitivity, specificity, or reader performance, as would be expected for a device relying on AI for interpretation.
The SOLOASSIST II is a robotic computer-driven system to hold and position a rigid laparoscope/endoscope. Its "performance" refers to its mechanical and software functionality, not the interpretation of medical images or data. The "acceptance criteria" discussed are largely related to safety, mechanical functionality, electrical safety, electromagnetic compatibility, software validation, and human factors.
Based on the provided text, here's what can be extracted, and where there are gaps regarding the typical understanding of a clinical study for AI-driven image interpretation devices:
1. A table of acceptance criteria and the reported device performance:
The document lists various tests and states that the device "complies" or the test was "performed successfully," implying that the acceptance criteria for those engineering and human factors tests were met. However, it does not present this as a formal table with specific quantitative acceptance criteria or corresponding quantitative results in the way one would for diagnostic performance.
Here are some examples of implicit "acceptance criteria" and "reported performance" derived from the text, though not in the requested table format:
| Acceptance Criteria (Implicit from Test Description) | Reported Device Performance (as stated in document) |
|---|---|
| Biocompatibility | Full biocompatibility evaluation conducted according to relevant standards (Directive 93/42/EEC, DIN EN ISO/IEC 17025:2005, GLP). Tests conducted: Cytotoxicity, Chemical analysis. (Implied: Met standards) |
| Electrical Safety | Complies with IEC 60601-1 standard. VOICE CONTROL also complies with IEC 60601-1 and IEC 60601-1-2. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. VOICE CONTROL also complies with IEC 60601-1-2. |
| Software Level of Concern for SOLOASSIST II | Considered "Moderate" level of concern. Complies with IEC 62304. |
| Software Level of Concern for VOICE CONTROL | Considered "Major" level of concern. Complies with IEC 62304. |
| Stable Fixation (Mechanical) | "Stable fixation of an endoscope: The system holds an endoscope in a fixed position, which was adjusted by the user. This must also be assured when power is lost." |
| Shifting after Manual Positioning (Mechanical) | Averaged measurement 2.93mm with 1kg load, 3 turns. (Implied: Within acceptable range) |
| Falling speed after 2 hours (Mechanical) | Max. 0.0024mm/min. (Implied: Within acceptable range) |
| Lifetime Test (Mechanical) | 35,000 movements in x-direction, 55,000 movements in y-direction, 35,000 movements in z-direction (movement length 30cm). Motor lifetime for at least 1000h (500h with cycle movement with radius 15cm and 28cm). (Implied: Criteria met) |
| Sound Test (Acoustic) | 64.0 dBA (pushing release button); 60.2 dBA (during active operation and 1kg load). (Implied: Within acceptable limits) |
| Human Factors | 15 operations conducted. Test performed successfully. No unexpected device-related events or patient-related adverse events occurred. |
| Packaging Drop Test (SOLOASSIST II) | No damage occurred. Drop height for mass 45-68kg was 200mm. |
| Packaging Drop Test (VOICE CONTROL) | No damage occurred. Drop height for mass |
§ 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.