(64 days)
This device is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
This device has an overrall lenght of 354mm. This diameter of the shaft is 2.7mm for direction of the center of field of view of 0/30/70 degrees. Diameter of the shaft of 4mm for direction of the center of field of view of 0/15/30/70 dearees. This device is composed of identical materials to that of the Sight-Plus Arthroscope.
The provided text is a 510(k) summary for a medical device called "Cystoscope 0/15/30/70 degrees 2.7mm/4mm". This document outlines the device's intended use, description, and claims of substantial equivalence to a predicate device.
Crucially, this 510(k) summary is from 1996 and pertains to a medical device that is a physical instrument (an endoscope) and not an AI/ML-based diagnostic or assistive software.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, expert involvement, and MRMC studies, which are standard for evaluating AI/ML medical devices, does not apply to this specific submission.
The 510(k) process for traditional devices like an endoscope focuses primarily on:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing related to the physical properties, materials, sterilization, and basic functionality of the instrument.
- Performance Benchmarking: Comparing the physical characteristics and functional performance (e.g., optical clarity, durability, illumination, sterility) to the predicate device.
- Safety Data: Ensuring materials are biocompatible, the device can be properly sterilized, and that design features minimize risks.
To directly answer your question based on the provided text, none of the requested information (acceptance criteria, study details for AI/ML performance, sample sizes, ground truth definitions, expert qualifications for reading, MRMC studies, standalone performance) can be extracted because the submission is for a physical endoscopy device, not an AI/ML system.
If this were an AI/ML device submission from the modern era, the 510(k) summary would contain a section detailing the clinical validation study's design and results, which would then include the type of information you requested.
§ 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.