(238 days)
The intended use of the AESOP System is a robotic computer driven system whose function is to hold and position a rigid laparoscope/endoscope . The AESOP 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 hysterectomy, laparoscopic anterior spinal fusion, 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 AESOP 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.
This document is a 510(k) summary for the AESOP System, a robotic computer-driven system for positioning laparoscopes/endoscopes. The information provided is insufficient to answer most of your questions, as it focuses on regulatory submission details and general device function rather than a clinical study demonstrating performance against specific acceptance criteria.
Here's what can be extracted and why other questions cannot be answered:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific acceptance criteria and detailed performance metrics are not explicitly stated. The document lists compliance with several international and national standards (IEC, UL, AMMI, EMC, CSA) and mentions "AESOP System Functional Test Requirements." This implies that internal functional tests were performed to demonstrate the device meets its design specifications and adheres to relevant safety and performance standards. However, the results of these functional tests are not reported in a manner that allows for a "performance" column to be filled as you'd typically expect for clinical efficacy or accuracy.
| Acceptance Criteria (from text) | Reported Device Performance |
|---|---|
| IEC 601-1 Second Edition 1988 | Not Specified |
| IEC 601-1 Amendment 1 1991 | Not Specified |
| IEC 601-2-18 First Edition 1990 | Not Specified |
| UL544 Third Edition | Not Specified |
| AMMI TIR 12 | Not Specified |
| EMC Directive European Union 89/336/EEC | Not Specified |
| CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 | Not Specified |
| AESOP System Functional Test Requirements (Details not provided) | Not Specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not describe any clinical study or test set involving patient data.
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)
This information is not provided. The document details regulatory compliance and intended use, but not the methodology for establishing ground truth for any performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The AESOP system is described as a robotic positioning system, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable to the stated function of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device's function is to assist a human surgeon in positioning a scope, not to operate autonomously in a diagnostic or therapeutic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The document does not mention any "training set," which would typically be associated with machine learning or AI algorithm development. The AESOP system is described as a robotic system with fixed functionalities.
9. How the ground truth for the training set was established
This information is not provided. (See explanation for point 8).
Summary of Missing Information:
The provided text is a regulatory summary for a medical device that assists in scope positioning. It focuses on declaring substantial equivalence to previous devices and compliance with established safety and performance standards. It does not contain information about:
- Clinical trials or studies involving patient data.
- Specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined clinical acceptance criteria.
- The use of AI/machine learning requiring training or test sets with ground truth.
- Human reader performance or MRMC studies.
To answer your questions comprehensively, a clinical study report or detailed technical documentation beyond this 510(k) summary would be required.
§ 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.