(270 days)
The TipVision™ 0°/30° Videoscopes and EleVision™ HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.
The Tip Vision™ Videoscope System, consisting of the Tip Vision 0° / 30° Videoscope and the EleVision™ HD 2 Camera Control Unit (CCU), is used for 2D visualization of anatomical structures of the human body during endoscopic surgery including general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic surgical procedures. The TipVision™ Videoscope can only be used with the EleVision™ HD 2 CCU; this combination of videoscope and camera controller results in a camera based on complementary metal-oxide-semiconductor (CMOS) technology with LED illumination. When used with a compatible monitor, the camera delivers a native full HD image resolution using progressive scanning (1080p). All parameters that can be adjusted through the user interface of the CCU (magnification, illumination brightness, saturation, selective color enhancement, color shift, image storage, etc.) can also be controlled by the buttons on the TipVision™ Videoscope.
The Tip Vision™ Videoscope is connected to the Ele Vision™ HD 2 CCU by means of a cable attached to the scope handpiece. The user has the ability to adjust videoscope imaging parameters using the buttons on the videoscope handle, or via the CCU. The EleVision™ HD 2 CCU is available in two configurations: image recording only, or image and video recording.
The provided text is a 510(k) summary for the TipVision Videoscope System. It describes the device, its indications for use, comparison to predicate devices, and a summary of non-clinical performance testing. However, it does not contain information about acceptance criteria and a study that proves an AI/ML device meets those criteria.
The document details testing related to:
- Reprocessing: Cleaning and sterilization validations per FDA guidance and AAMI/ISO standards.
- Biocompatibility: Evaluation and testing according to ISO 10993 series and USP .
- Performance Testing (Optical and Mechanical): Optical characteristics (field of view, resolution, color, etc.), photobiological safety, thermal safety, usability, noise/dynamic range, and tip rotation per ISO and IEC standards.
- Software Documentation: Adherence to FDA guidance for Moderate Level of Concern devices and IEC 62304.
- Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601 series.
All these tests are for the physical and software aspects of a traditional medical device (a videoscope system), not for an AI/ML-driven device that would have "acceptance criteria" related to its algorithm's performance (e.g., accuracy, sensitivity, specificity, AUC) and requiring a "test set" with "ground truth" established by experts.
Therefore, I cannot fulfill the request for a table of acceptance criteria and the study proving an AI/ML device meets them, as the provided text does not describe an AI/ML device or its associated performance studies. The request specifically asks for details related to "AI vs without AI assistance," "standalone (algorithm only) performance," and "ground truth" establishment, which are concepts relevant to AI/ML device validation and are entirely absent from this 510(k) summary.
§ 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.