(94 days)
VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus. Do not use the instrument for any purpose other than its intended use.
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the uterus.
The provided document does not describe an AI medical device. It is a 510(k) summary for a "VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V (HYF-V)", which is a hysterovideoscope for endoscopic diagnosis within the uterus.
The document discusses various non-clinical bench tests (e.g., thermal safety, photobiological safety, noise and dynamic range, composite durability, color performance, image intensity uniformity, resolution, direction of view, field of view), biocompatibility evaluation, sterilization/reprocessing validation, and electrical safety/EMC testing. It explicitly states that software verification and validation testing was not applicable and not performed because the HYF-V does not include any software.
Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria for an AI device based on this document. The questions regarding sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the information provided for this hysterovideoscope.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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.