(114 days)
The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder.
The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.
The devices are for use in professional Healthcare Facility Environment.
The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.
The provided document, a 510(k) summary for the Hunan Vathin Medical Instrument Co. Ltd's Single-use Flexible Cystoscope and Digital Video Monitor, describes non-clinical performance testing for device acceptance and claims substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets acceptance criteria through clinical performance metrics, multi-reader multi-case (MRMC) studies, or AI-assisted diagnostic improvements. The document focuses on bench testing, biocompatibility, electrical safety, sterilization, software validation, and cybersecurity.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics on sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how training ground truth was established. This information is typically found in clinical validation studies, which are not detailed in this 510(k) summary.
The document primarily addresses the safety and fundamental performance of the device itself (e.g., optical properties, mechanical bending, material biocompatibility) rather than its diagnostic accuracy or impact on human reader performance, especially in relation to AI assistance.
Despite the lack of information to fully address your request, here's what can be extracted from the document regarding acceptance criteria for non-clinical performance:
1. A table of acceptance criteria and the reported device performance (based on non-clinical tests):
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance and Compliance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1:2018 for "Surface - Mucosal Membrane" ( |
§ 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.