(154 days)
The AESOP 3000 System is intended to be used as a robotic, computer-driven system whose function is to hold and position a rigid laparoscope/endoscope. The AESOP 3000 System is indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a rigid laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, 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 AESOP 3000 System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The AESOP 3000 System is a robotic computer-driven system whose basic function is to hold and position a laparoscope/endoscope under the direct control of a surgeon.
The AESOP 3000 System is a robotic, computer-driven system whose basic function is to hold and position a laparoscope/endoscope under the direct control of a surgeon. The device's acceptance criteria are based on compliance with various international and national standards for medical electrical equipment and reprocessing of medical devices, as well as internal functional test requirements.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| International Standards | IEC 601-1 Second Edition 1988 | Device designed and tested to this standard. |
| IEC 601-1 Amendment 1 1991 | Device designed and tested to this standard. | |
| IEC 601-2-18 First Edition 1990 | Device designed and tested to this standard. | |
| National Standards | UL 2601-1 | Device designed and tested to this standard. |
| AMMI TIR 12 | Device designed and tested to this standard. | |
| CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 | Device designed and tested to this standard. | |
| European Union Directive | EMC Directive 89/336/EEC | Device designed and tested to this directive. |
| Internal Requirements | AESOP 3000 System Functional Test Requirements | Device designed and tested to these requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a separate "test set" in the context of a clinical performance study with human subjects or a dataset for AI validation. The device's performance is primarily established through compliance with engineering and safety standards, and functional testing. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature for a test set in the conventional sense is not available in this filing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
As the acceptance criteria are based on compliance with engineering, safety, and functional standards rather than diagnostic accuracy or clinical outcomes evaluation in a traditional sense, the concept of "experts to establish ground truth" also does not directly apply in the context of this 510(k) summary. The experts involved would likely be engineers, quality assurance personnel, and regulatory affairs specialists who ensured the device met the specified technical and safety standards. Their qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set:
Given the nature of the acceptance criteria (compliance with standards and functional testing), an "adjudication method" as typically used for clinical endpoints or diagnostic accuracy (e.g., 2+1, 3+1) is not applicable to this submission. Evaluation would involve engineering verification and validation processes against the specified standards and functional requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Based on the provided document, there is no mention of an MRMC comparative effectiveness study being conducted or its results. The AESOP 3000 System is a robotic tool that assists surgeons in positioning an endoscope, not a diagnostic imaging device that requires interpretation by multiple readers. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant or reported here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The AESOP 3000 System is explicitly described as a "robotic computer-driven system whose basic function is to hold and position a laparoscope/endoscope under the direct control of a surgeon." This means it is inherently a human-in-the-loop device. Therefore, a standalone (algorithm only) performance study does not apply to this device's function or evaluation as described in the 510(k) summary.
7. Type of Ground Truth Used:
The "ground truth" for the AESOP 3000 System's acceptance is based on its technical specifications, functional requirements, and compliance with established industry and international safety standards. This is not ground truth in the sense of a medical diagnosis (e.g., pathology, outcomes data, or expert consensus on disease presence). Rather, it's about verifying that the robotic arm moves as intended, responds to surgeon controls, and meets safety parameters.
8. Sample Size for the Training Set:
Since the AESOP 3000 System is a robotic surgical assistant and not an AI/ML diagnostic tool, the concept of a "training set" for machine learning algorithms is not applicable in the context of this 510(k) summary. The device's operation is dictated by its programmed mechanics and controls, not by learning from a training dataset.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" for machine learning, the establishment of ground truth for such a set is not relevant or described in this document.
§ 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.