(121 days)
LTF-190-10-3D: This instrument is intended to be used with Olympus video system center, light source, documentation equipment, 3D processor, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. In addition, this instrument must not contact with any device or therapeutic accessory that contacts the heart or any area near the heart.
CV-190: This video system center is intended to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
MAJ-Y0154: This 3D processor is intended to be used with 3D videoscope and video system center for 3D observation.
The subject system is intended for endoscopy and endoscopic surgery with three-dimensional view of endoscopic images and the system is mainly composed of following devices: LTF-190-10-3D (ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE), MAJ-Y0154 (3D PROCESSOR), CV-190 (EVIS EXERA III VIDEO SYSTEM CENTER). The ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-3D is a flexible video endoscope used for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. The subject device, LTF-190-3D is utilized with the MAJ-Y0154, 3D Processor and the CV-190, EVIS EXERA III VIDEO SYSTEM CENTER. The connection of the devices enables the system for endoscopic observation in 3D view of the image. The 3D video observation of this system is implemented with following process. The captured signals from two CCDs which correspond to left and right eye incorporated in the distal end of the subject LTF-190-10-3D are transferred to the MAJ-Y0154 via two CV-190s convert the captured signals into video image signals, and transmits them to the MAJ-Y0154. The MAJ-Y0154 converts the video image signals into 3D video signal and transfers it to the LMD-2451MT, (K113203). On the LMD-2451MT, 3D video image is displayed as passive stereo type which has different polarizing angle in the left and right; therefore, the 3D glasses for LMD-2451MT are required to obtain 3D video image.
The provided text describes a 510(k) summary for Olympus medical devices, specifically an endoscope, a 3D processor, and a video system center. The summary focuses on demonstrating substantial equivalence to predicate devices through design verification and non-clinical testing. It does not include information about AI/ML models, clinical studies, or acceptance criteria related to diagnostic performance or accuracy of an AI model.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to an AI model.
- Sample size and data provenance for an AI test set.
- Number and qualifications of experts for AI ground truth.
- Adjudication method for an AI test set.
- MRMC comparative effectiveness study results for AI.
- Standalone performance results for an AI algorithm.
- Type of ground truth for an AI model.
- Sample size for an AI training set.
- How ground truth for an AI training set was established.
This document describes technical aspects and safety testing for endoscopic hardware, not an AI-powered 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.