(221 days)
The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. The devices is suitable for professional healthcare facility environments such as hospitals and clinics.
The Single-Use Video Hysteroscope is intended to be used for viewing of the adult cervical canal and uterine cavity and it is provided sterile (sterilized by EO) and intended for single use only. The Single-Use Video Hysteroscope is composed of a handle part, including the video cable interface, working channel port and instrument channel port, and an insertion portion, of which a camera module and LED light source are integrated inside the distal tip. There are two models of The Single-Use Video Hysteroscope, RP-G-C24 and RP-G-C0101. The model RP-G-C24 is identical to RP-G-C0101 except for the direction of view, width size of insertion port and width size of instrument channel. The principle of optical imaging: the light source illuminates the inspected site of the patient, which is imaged by the photosensitive surface of CMOS camera module. The optical signal received by the CMOS sensor is converted into electrical signal after processing. The electrical signal is then transmitted by the cable to the signal processing chip embedded on the Endoscopic Video Image Processor where it is restored after processing and finally displayed on the screen of Endoscopic Video Image Processor.
The FDA 510(k) summary provided does not describe an AI/ML-based device, but rather a Single-Use Video Hysteroscope. Therefore, the acceptance criteria and study detailed in the document pertain to the safety and performance of this medical device, not an AI/ML algorithm.
The request asks for information relevant to an AI/ML device, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample size for test sets (distinguishing between training and test sets), expert adjudication, multi-reader multi-case studies, and ground truth establishment using pathology or outcomes data. These concepts are not applicable to the evaluation of the hysteroscope as described in the document.
The document discusses performance data related to:
- Biocompatibility (cytotoxicity, skin sensitization, intracutaneous test, acute systemic toxicity)
- Electrical Safety and Electromagnetic Compatibility
- Photobiological safety
- Sterilization Validation
- Shelf Life and Sterile Barrier System (Packaging)
- Bench Performance Data for optical (Direction of view, Resolution, Depth of Field, Field of view, Geometric Distortion, Signal-To-Noise Ratio, Dynamic Range, Image Intensity Uniformity (IIU), Color Performance, Surface Safety) and mechanical properties (Basic Size, Water Supply System, Sealing Performance, Tensile strength).
Therefore, I cannot provide the requested information in the format of AI/ML device evaluation criteria based on the provided text. The document confirms that clinical evidence and animal studies were not applicable for this device submission (Sections VIII.A and IX).
If the intent was to understand the regulatory submission for the RP-G-C24, RP-G-C0101 Single-Use Video Hysteroscope, the relevant acceptance criteria and studies would be derived from the non-clinical performance testing summarized in Section VIII. These are performance metrics for a physical device, not an AI algorithm.
§ 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.