(57 days)
The Smith & Nephew Operative Hysteroscope and accessories are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The proposed Smith & Nephew Operative Hysteroscope and Accessories is a reusable surgical device that incorporates a working channel into the needle portion of the hysteroscope. A reusable continuous flow sheath and blunt obturator are offered for atraumatic insertion through the uterine cervix. The needle portion of the hysteroscope has an oval configuration to accommodate adequate fluid flow between the sheath and hysteroscope. The working channel is D-shaped to accommodate the fiber bundles and optical train in the needle. The Smith & Nephew Operative Hysteroscope is compatible with the ETO and autoclave sterilization process. The device accessories can be autoclaved for reuse.
The provided document is a 510(k) summary for the Smith & Nephew Operative Hysteroscope and Accessories. It describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).
The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing detailed performance data from new studies. The critical information required to answer your questions about acceptance criteria and study details is explicitly missing from this type of regulatory document.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document states: "Smith & Nephew's Operative Hysteroscope and accessories is substantially equivalent in design, materials of construction, function and intended use to the Smith & Nephew Images Hysteroscopes and accessories and the Richard Wolf operative Hysteroscopes. The changes in geometry do not introduce any new risks to the proposed device." This indicates that the regulatory approval is based on equivalence to existing devices, not on a new clinical study with new acceptance criteria.
§ 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.