(314 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 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 surgeons, thoracic surgeons and urologists.
The intended use of the DEXTER ENDOSCOPE ARM is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The DEXTER ENDOSCOPE ARM is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, DEXTER ENDOSCOPE ARM 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 DEXTER ENDOSCOPE ARM are general surgeons, gynecologists, cardiac surgeons and urologists.
The intended use of the ARTip solo is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.
The ARTip solo is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, ARTip solo is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic, decompression fixation, wedge resection, lunq 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 ARTip solo are general surgeons, gynecologists, cardiac surgeons and urologists.
DEXTER ENDOSCOPE ARM and ARTip solo + ARTip solo voice are based on the same concept as the already cleared SOLOASSIST II + Voice Control (K200473) and differ only in minor details. All 3 robotic arm systems emulate an arm operating in multiple degrees of freedom. The intended use of the three robotic arm systems is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The surgeon can control the arm with either a joystick, voice control, or by pressing a button on the distal end of the arm. Movement is controlled by 3 motorized axes. The endoscopic camera is registered in the TROCAR POINT, which serves as the pivot point. Starting from this zero point, the device independently calculates the required individual movements of the axes to achieve the desired overall movement. The system offers a wide range of motion, allowing a 360° panoramic view with the endoscope tilted up to 90° from the vertical. Despite their wide range of motion, all arms are lightweight and compact and are attached directly to the operating table with a quick-release clamp. Only a STERILE COVER is required for safe use.
The ARTip solo is functionally identical to the already cleared SOLOASSIST II (K200473), but differs only in the color and inscription of the covers and the visual design of the control panel on the arm.
The ARTip solo can also be controlled with the ARTip solo voice. This is also identical to the already cleared VOICE CONTROL (K200473) except for the color and inscription. The ARTip solo is not compatible with the VOICE CONTROL (K200473).
In addition, the ARTip solo can also be controlled with a joystick. It can only be controlled with the JOYSTICK-IH-IA or JOYSTICK-RH-IIA, which are specially made for the ARTip solo and are only compatible with it.
DEXTER ENDOSCOPE ARM is the trade name of the SOLOASSIST IID, which was developed within the SOLOASSIST II. The special feature of the DEXTER ENDSCOPE ARM is that it provides an interface to a customer-specific device and can be controlled by it.
The arm can also be controlled by the JOYSTICK LH and JOYSTICK RH.
The SOLOASSIST IID has its own CANTILEVER, JOINT, PROBE PIN and ENDOSCOPE CLAMP, which in combination with a tension sleeve hold the endoscope.
I am sorry, but the provided text does not contain the detailed information necessary to complete some sections of your request. Specifically, it lacks data on:
- Specific acceptance criteria for individual performance metrics.
- Sample sizes for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone algorithm performance.
- Type of ground truth for the test set.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text focuses on demonstrating substantial equivalence to a predicate device based on technological similarity and non-clinical testing. It states that new devices "can be classified as equally safe and effective as the predicate device" based on these tests, but does not provide specific performance metrics or detailed study designs for acceptance criteria.
Therefore, I cannot populate all the requested fields. However, I can provide the information that is present in the document which describes the testing and conclusions regarding the devices' safety and effectiveness.
Here's a summary of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list specific numerical acceptance criteria or quantitative performance metrics for the device. Instead, it refers to non-clinical tests carried out with predicate devices and additional tests for the new devices to "prove the safety and effectiveness with regard to the differences to the predicate device." The conclusion is that the new devices are "as safe and effective as the predicate device."
- Acceptance Criteria: Not explicitly stated with numerical values. The implicit acceptance criterion is likely to demonstrate equivalence in safety and effectiveness to the predicate device through successful completion of the listed non-clinical tests and software verification.
- Reported Device Performance: The document concludes that "The non-clinical tests have shown that the SOLOASSIST IID, ARTip solo voice and SOLOASSIST II + VOICE CONTROL are as safe and effective as the predicate device." No specific quantitative performance data (e.g., accuracy, precision, error rates) are provided.
Table of Acceptance Criteria and Reported Device Performance (Based on provided text, specific metrics are not detailed)
| Performance Metric Category | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Safety | - Successful completion of non-clinical safety tests. | - Demonstrated to be as safe as the predicate device. |
| Effectiveness | - Successful completion of non-clinical functional tests. | - Demonstrated to be as effective as the predicate device. |
| Software Performance | - Software verification confirming no negative influence on safety and performance. | - Software verified; no negative influence on safety and performance. Compatability between devices checked via software verification. |
| Cybersecurity | - Compliance with FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". | - Evaluated in accordance with FDA Guidance (September 2023) "Cybersecurity in Medical Devices..." demonstrating compliance with section 524B of FD&C Act. |
| Cantilever & Interfaces | - Verification of cantilever and interfaces for SOLOASSIST IID. | - Verified for SOLOASSIST IID. |
| Packaging | - Packaging validation. | - Validated. |
| Functional Performance | - Functional integrity for various controls and movements. | - Demonstrated by successful "Temperature test, lifetime test, moving after fixation, quick release connector test, headset (functional test), movement voice control (functional test), bluetooth reach test, voice commands (functional test)." |
| Usability | - Successful usability testing. | - Usability test conducted successfully. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for test sets, nor does it provide information on data provenance (country of origin, retrospective/prospective) as the tests described are non-clinical, likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests mentioned are non-clinical (e.g., temperature, lifetime, functional tests) and do not involve expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as expert adjudication for ground truth is not mentioned for the non-clinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device (SOLOASSIST IID / DEXTER ENDOSCOPE ARM, ARTip solo, ARTip solo voice, SOLOASSIST II, VOICE CONTROL) is described as a robotic computer-driven system to hold and position endoscopes, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is outside the scope of this device's intended use and the provided documentation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the entire device system (robotic arm with its software and controls), not a standalone algorithm in the context of AI diagnostic performance. The non-clinical tests described (e.g., temperature, lifetime, functional tests for various components and control methods) represent tests of the device in its standalone (intended operational) capacity, without human intervention for evaluation of diagnostic output. The device itself is designed to be operated by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests conducted, the "ground truth" would be established by engineering specifications, physical measurements, and functional requirements of the device and its components (e.g., a power supply providing the correct voltage, a quick-release connector functioning as designed, voice commands being correctly interpreted). It is not expert consensus, pathology, or outcomes data in the medical diagnostic sense.
8. The sample size for the training set
Not applicable, as the document describes a robotic surgical assistant system and associated controls, not an AI algorithm that requires a "training set" in the machine learning sense for diagnostic purposes. The software changes mentioned are related to bug fixes, parameter additions, and compatibility checks, not statistical model training.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.