(212 days)
AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The AED Hysteroscope and Accessories is a reusable surgical device that incorporate operative and examination sheaths. The AED Hysteroscope is a reusable rod lens Hysteroscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem. Examination Sheaths are designed to be used with a hysteroscope alone. An operative sheath is an examination sheath with one or more instrument channels. The operative and examination sheaths are composed of surgical grade stainless steel with the exception of a Fixing Ring (where applicable) which is composed of Nylon. There are two designs for Continuous Flow Sheaths. One design consists of a single sheath with two interior channels (18-2307 and 18-2308) for the inflow and outflow of media to be used with the hysteroscope alone. Alternatively, an inner and outer sheath may be used to perform the same function (18-2304 and 18-2309). The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
The provided document is a 510(k) Premarket Notification summary for the AED Hysteroscope and Accessories. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing the kind of detailed performance study data typically associated with a medical AI/software device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to a specific performance study where a device's performance metrics are reported against predefined targets. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- Information on expert ground truth establishment for test or training sets.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes for human readers.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
Instead, the document primarily focuses on demonstrating that the AED Hysteroscope and Accessories are substantially equivalent to predicate devices (Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope K935716) in terms of:
- Intended Use: "to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." (Pages 2, 5)
- Technological Characteristics: They share the same operating principle, basic mechanical design, and are manufactured using the same materials. The main difference noted is the predicate's adjustable ocular lens versus the AED Hysteroscope's fixed non-adjustable one. (Page 5)
Performance Testing:
The document briefly mentions "Performance Testing" on page 6, stating:
- "Testing was performed according to IEC 60601-2-18. Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate devices. The AED Hysteroscope and Accessories met all specified design and performance requirements."
- "The device conforms to ISO 8600-4:2014, 8600-1:2013, 8600-3:1997 Amendment 1 2003, 8600-5:2005, 8600-6:2005 and IEC 60601-2-18 (1996) and IEC 60601-2-18 Edition 3.0 2009-08."
This indicates that the device underwent bench testing to meet established industry performance standards for hysteroscopes, focusing on hardware safety and functionality (e.g., thermal performance, simulated use). However, it does not provide specific performance metrics (like sensitivity, specificity, accuracy) that would be relevant for an AI/software device. The "acceptance criteria" here are implied to be adherence to the safety and performance requirements of the cited IEC and ISO standards.
Conclusion:
This document is a regulatory submission for a physical medical device (hysteroscope), not an AI/software medical device. Therefore, it does not contain the specific information requested about acceptance criteria and performance studies in the context of AI development and validation. The "study" referenced is compliance testing against established international standards for hysteroscopes to demonstrate substantial equivalence, not a clinical performance study with human readers or standalone algorithm performance.
§ 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.