Search Results

-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.

Ask a specific question about this device