(55 days)
The SCB/ConMed ESU Interface Module is an accessory to a Karl Storz-SCB control devices (SCB Interface Control, SCB Media Control or ACC Control) which allows for use of the third party device, ConMed ESU models 2450/5000. The ESU's are remote controlled surgical generators operated by a Karl Storz-SCB control device via the Karl Storz interface module.
The Karl Storz SCB/ConMed ESU Interface Module is an accessory to integrate the third party devices ConMed ESU models 2450/5000 units to a Karl Storz-SCB control device and permits remote control via the Storz SCB-RUI System.
I am sorry, but based on the provided document, I cannot fulfill your request. The document describes a 510(k) premarket notification for an "SCB/ConMed ESU Interface Module," which is an accessory to integrate third-party devices. This is a medical device, but it is not an AI/ML powered device.
The information you are asking for, such as acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, are typical requirements for evaluating the performance of AI/ML-powered medical devices. Since this device is an interface module and not an AI/ML algorithm, these types of performance evaluation metrics are not present in the provided documentation.
The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway for non-AI/ML devices. Therefore, I cannot extract the AI/ML-specific information you've requested from this text.
§ 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.