(229 days)
-OLYMPUS URF-V3/V3R: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney.
-OLYMPUS URF-P7/P7R: This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).
URF-V3 and URF-V3R have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter and kidney. This endoscope is a videoscope, composed of flexible insertion tube, control section, light guide connector and video connector, and equipped CCD for image transfer system. The difference between URF-V3 and URF-V3R is angle overation direction. The bending section of the URF-V3R moves towards the direction oppositely to that of the URF-V3.
URF-P7 and URF-P7R have been designed to be used with an Olympus light source, documentation equipment. Monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). This endoscope is a fiberscope, composed of flexible insertion tube, control section and eyepiece section, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for directly visual observation or video camera connection. The difference between URF-P7 and URF-P7R is angle operation direction. The bending section of the URF-P7R moves towards the direction oppositely to that of the URF-P7.
The provided text is a 510(k) Pre-market Notification for medical devices, specifically uretero-reno videoscopes and fiberscopes. It outlines the company's claim of "substantial equivalence" of these new devices (OLYMPUS URF-V3/V3R and URF-P7/P7R) to previously cleared predicate devices (OLYMPUS URF-V2/V2R and URF-P6/P6R).
However, the document does not contain information about a study proving that an AI-powered device meets specific acceptance criteria related to a diagnostic or treatment outcome. Instead, it focuses on the engineering and safety aspects for a medical device being cleared through the 510(k) pathway, which primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot extract the information required to answer your request about acceptance criteria and a study proving an AI device's performance against specific clinical metrics, because this document does not describe such a study.
The closest information provided related to "testing" or "studies" are:
- Non-clinical testing: This includes reprocessing instruction validation, biocompatibility testing, software verification and validation (including cybersecurity), electrical safety, electromagnetic compatibility (EMC), and performance testing. These are engineering and safety tests, not clinical performance studies measuring diagnostic accuracy or treatment effectiveness.
- Risk analysis: Stated as carried out in accordance with ISO 14971:2007, and design verification tests and their acceptance criteria were identified and performed as a result of this. Again, this points to product design and safety, not clinical performance metrics for an AI.
In summary, none of the requested information regarding an AI device's performance study (acceptance criteria as specific performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC study, standalone performance, etc.) is present in this 510(k) notification.
§ 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.