(266 days)
Used for collection of cells in the biliary system.
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush and Fusion® Cytology Brush (predicate devices) cleared to market via 510(k) K171573 by Wilson-Cook Medical, Inc.
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a nylon brush on a stainless-steel drive wire with a stainless-steel tip, a double lumen catheter with ink markings, radiopaque markers, wire guide access via a wire guide hub or an IDE port, a detachable extension line with a leur lock for optional flushing of the wire guide hub and a pinvise handle.
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes are used by passing the device through an endoscope over a prepositioned wire guide to a target location. The cytology brush is located at the distal end (patient contacting) of the device with the pin vise handle located at the proximal end (non-patient contacting). The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.
This document is a 510(k) summary for a medical device (Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush) and primarily focuses on demonstrating substantial equivalence to a predicate device based on modifications and non-clinical bench testing. It does not present a clinical study or performance data related to AI/algorithm performance, which is what your request is specifically asking for regarding acceptance criteria, training/test sets, ground truth establishment, or human reader improvement with AI assistance.
Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document does not contain any details about:
- Acceptance criteria and reported device performance (in the context of an AI/algorithm). The "performance data" mentioned here refers to mechanical and material properties, not clinical diagnostic accuracy or AI metrics.
- Sample sizes used for a test set or data provenance for an AI/algorithm.
- Number of experts and their qualifications for establishing ground truth for an AI/algorithm.
- Adjudication method for a test set for an AI/algorithm.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone (algorithm-only) performance.
- Type of ground truth used for an AI/algorithm.
- Sample size for the training set for an AI/algorithm.
- How ground truth for the training set was established for an AI/algorithm.
The document states: "Performance testing consisting of non-clinical bench testing that demonstrates the subject devices met the performance requirements to fulfill their intended use. This testing provides reasonable assurance that the subject devices will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices." This highlights that the evaluation was primarily focused on bench testing for mechanical and material properties, not clinical performance metrics typical for AI-powered diagnostics.
§ 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.