(90 days)
The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.
The Disposable Distal Attachment D-201 Series is comprised of seven (7), sterile, single-use, distal attachments of varying diameters. Each distal attachment is a short transparent plastic tube which is attached to the distal end of an endoscope to facilitate observation of tissues during endoscopic procedures. A subset of the models includes a drainage side hole that allows egress of water and blood during use. The Disposable Distal Attachment D-201 Series is to be used with compatible endoscopes.
The provided FDA 510(k) clearance letter and summary for the "Disposable Distal Attachment D-201 Series" does not describe a study involving an AI/Medical Imaging device that requires ground truth, human readers, or a test set as described in the prompt.
Instead, this document describes a traditional medical device (a physical accessory for an endoscope) and the performance testing conducted to demonstrate its substantial equivalence to a predicate device. The performance data focuses on biocompatibility, sterilization, packaging, shelf-life, mechanical testing, and human factors. There is no mention of an algorithm, image analysis, or clinical performance in terms of diagnostic accuracy or reader improvement.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided information, as the requested elements (ground truth, expert consensus, MRMC studies, training/test sets for an algorithm, etc.) are not applicable to this type of device and its clearance process.
The document states: "Clinical data is not required to demonstrate substantial equivalence." This further confirms that no studies involving analysis of images or AI performance were conducted or necessary for this device's clearance.
§ 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.