(150 days)
The U-Scope device is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding; infertility and pregnancy wastage; evaluation of abnormal hysterosalpingogram; intrauterine foreign body; amenorrhea; and pelvic pain.
The EndoSee U-Scope Model 8000 is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable hysteroscopic cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at the tip and a channel for infusion of irrigating fluid. The disposable cannula is sterilized and packaged in a sealed bag. The handle is light weight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the cannula. The handle contains the remaining electronics including a power on/off button, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers and firmware.
The provided text describes the U-Scope Model 8000 hysteroscope and its substantial equivalence to predicate devices. However, the document primarily focuses on regulatory approval (510(k) submission) and does not contain information about acceptance criteria for an AI/algorithm-based device, nor a study proving general device performance against such criteria, nor any of the specific details requested in points 2-9 for an AI device study.
The "Performance Data" section (Page 4-5) lists various bench tests conducted to ensure compliance with standards for biocompatibility (ISO 10993), electrical safety (ISO 60601-1, ISO 60601-1-2, IEC 60601-2-18), thermal safety, mechanical characteristics, software verification and validation, sterilization validation (ISO 11135-1, ISO 11607, AAMI TIR12:2010), handling reprocessing (AAMI TIR30:2011), battery specifications, durability, and a general mention of optics performance and image quality testing. These are standard performance tests for the physical device, not an AI or algorithm's diagnostic performance.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding:
- Acceptance criteria for an AI/algorithm. The document discusses acceptance criteria for physical components and compliance with medical device standards.
- A study proving the device meets AI-specific acceptance criteria. The "Performance Data" describes bench testing for device safety and functionality.
- Sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI algorithm.
The device described is a physical hysteroscope, not an AI or algorithm-based diagnostic tool.
§ 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.