(84 days)
The Universal Operating Hysteroscope Set is used for dilating the cervical channel, the cavum uteris (using fluid or CO2 gas), and for visualization of the tubal ostia. The scope is applied via the natural passage.
The universal operating hysteroscope set has exchangeable inner sheaths that are inserted into the endoscope containing an angled eyepiece. The endoscope tube consists only of the pure optical system with the light fibers. This allows enough room for various inner sheaths with the operating channel, combined with outer sheaths. The submitted universal hysteroscope set is an inexpensive alternative for compact instruments for outpatient gynecologists.
The provided text indicates that no clinical tests were performed to prove the device meets acceptance criteria. Therefore, the following information cannot be extracted from the given document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Instead, the document states:
5.0 Performance Data
No performance standards are known.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
This indicates that the device's safety and effectiveness were established through design and engineering tests (not specified in detail) and by claiming substantial equivalence to predicate devices, rather than through specific performance metrics derived from a clinical study.
§ 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.