(273 days)
The WV1 endoscope is a reusable, rigid, video endoscope, designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.
The WV1 System is comprised of two main components: WV1 endoscope (Video endoscope) and FuseBox (Video Processor, cleared under (K132839). The WV1 endoscope is a reusable, rigid, video endoscope. The device has been designed to be used with a compatible video system, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as after each use. The WV1 endoscope main components are the distal tip, the endoscope body and the endoscope main connector. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects a video signal produced by the CCD (Charge Couple Device). The video assembly that controls the field view and image characteristics, including video resolution and brightness, is located in the endoscope's distal tip. The WV1 Distal Tip is equipped with a color CCD and covers a 90° field of view. The extended field of view is achieved by use of additional 2 lenses located behind the endoscope's distal tip, each attached to a separate CCD. The geometrical location of the lenses allows for image overlap that results in the extended field of view (enabled by operation of the Fusebox). Each view on the distal tip has its own dedicated illumination source (LEDs). The images are presented side by side on a display monitor.
This document describes the 510(k) premarket notification for the WV1 Endoscope. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI-driven device meets specific performance acceptance criteria for a diagnostic task.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves an AI-driven device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- Information on MRMC studies, standalone performance.
- Types of ground truth used or how it was established for training and test sets.
The document discusses non-clinical performance testing for a medical device (an endoscope), not a software or AI-driven diagnostic system. The "bench testing" mentioned refers to physical characteristics and optical performance of the endoscope, not diagnostic accuracy.
In summary, the provided document is a 510(k) submission for an endoscope and does not contain the information necessary to address the prompt's request regarding acceptance criteria and study results for an AI-driven diagnostic device.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.