(231 days)
PENTAX Medical Video Duodenoscope ED34-i10T2s: The PENTAX Medical Video Duodenoscope ED34-i10T2s is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
PENTAX Gas/Water Feeding Valve OF-B194: Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.
PENTAX Medical Video Processor EPK-i8020c: The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.
PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63: The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.
PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Processor, documentation equipment, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the biliary tract via the upper gastrointestinal tract. The PENTAX Medical Video Duodenoscope ED34-i10T2s is compatible with the hydrogen peroxide gas plasma sterilizer STERRAD 100NX.
The provided document is a 510(k) summary for a medical device (PENTAX Medical Video Duodenoscope ED34-i10T2s and accessories). It outlines the device's characteristics, intended use, and comparison to predicate devices, along with non-clinical performance data.
However, the document does not contain information related to a study proving that an AI device meets acceptance criteria, nor does it provide details about human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for training or test sets related to AI.
The document primarily focuses on demonstrating substantial equivalence of a medical endoscope and its accessories to previously cleared predicate devices through engineering and functional performance testing, reprocessing validation, biocompatibility, electrical safety, and software validation (for a video processor which includes an image enhancement technology, but not an AI diagnostic algorithm in the sense of the prompt's request).
Therefore, I cannot extract the requested information about acceptance criteria for an AI device and related studies from this document. The information you are asking for (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for AI ground truth, MRMC studies for AI, standalone AI performance) is not present in this regulatory submission for an endoscope.
§ 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.