(271 days)
The Single-use Flexible Ureteroscope is designed for use with Vathin Display Units, endotherapy accessories and other ancillary devices for the endoscopy and endoscopic surgery within urinary tract and kidney in adults.
The Digital Video Monitor is specially designed to be used with medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The Video Ureteroscope System consists of Single-use Flexible Ureteroscope (Model:US-S2600, US-E2600) and Digital Video Monitor(Model:DVM-B1) . During diagnosis and treatment with the Video Ureteroscope System, the Single-use Flexible Ureteroscope is inserted into the ureter or into the kidney or renal pelvis through the ureter, and the image sensor (CMOS) at the end of the Single-use Flexible Ureteroscope converts the received mucosal reflected light signals into electrical signals , transmitted to the Digital Video Monitor through the cable, the Digital Video Monitor receives the image signal from the endoscope and processes it, converts it into an image signal that can be displayed on the display screen, and finally presents it on the screen of the display.
I am sorry, but the provided text from the FDA 510(k) notification for the "Video Ureteroscope System" does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device.
The document primarily focuses on:
- Substantial equivalence to a predicate device (another ureteroscope system).
- Device description (components, how it works).
- Indications for use.
- Comparison of technological characteristics with the predicate device.
- Summary of non-clinical tests (biocompatibility, sterility, electrical safety, EMC, and general performance testing).
There is no mention of an AI or Machine Learning component in the device. Therefore, the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML system.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for AI/ML ground truth.
- MRMC comparative effectiveness study results for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth for an AI system.
- Sample size for an AI training set.
- Ground truth establishment for an AI training set.
cannot be extracted from this document.
The document states that "Performance testing was conducted on the Video Ureteroscope System." (page 8), but it does not detail what specific performance tests were conducted, what the acceptance criteria were for those tests, or the results, beyond a general statement that "The non-clinical testing demonstrates that the device is as effective and performs as well as the legally marketed device." This general statement refers to the functional performance of the ureteroscope system itself (e.g., image quality, bending angle, working length, irrigation, etc.) compared to its predicate, not the performance of an AI algorithm.
§ 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.