(188 days)
The Microendoscope system is used to apply and maintain pneumoperitoneum for laparoscopic procedures and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and hysteroscopic procedures.
Cannula and tubes are made of medical grade stainless steel and chrome plated brass.
Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glass-fibers, brass chrome plated (housing), and plastic (eyepiece).
As the intended use describes, the set is miniaturized in diameter and length for minimally invasive laparoscopy. The veress cannula and the tubes are larger in diameter and longer in working length. The telescopes are shorter in length and smaller in diameter.
The provided text is a 510(k) summary for the Richard Wolf Mini Laparoscopes and Microendoscope System. It details the device's description, intended use, and claims of substantial equivalence to existing devices. However, the document explicitly states that "No clinical tests performed" and does not provide any acceptance criteria or performance data from a study to prove these criteria were met.
Therefore, I cannot populate the requested table or sections with information that is not present in the provided text.
Here's a summary of what is available regarding testing and performance, based on the input:
| Section | Information from Document |
|---|---|
| Acceptance Criteria & Reported Device Performance | Not specified. The document states a claim of "substantial equivalence" to predicate devices. |
| Sample size for the test set and data provenance | Not applicable, as no clinical tests were performed. |
| Number of experts used to establish ground truth & qualifications | Not applicable, as no clinical tests were performed. |
| Adjudication method for the test set | Not applicable, as no clinical tests were performed. |
| Multi-Reader Multi-Case (MRMC) comparative effectiveness study | No. The document explicitly states, "No clinical tests performed." |
| Standalone (algorithm only) performance study | Not applicable, as this is a medical instrument (laparoscope/microendoscope system), not an algorithm or AI device. The document explicitly states, "No clinical tests performed." |
| Type of ground truth used | Not applicable, as no clinical tests were performed. |
| Sample size for the training set | Not applicable, as this is a medical instrument (laparoscope/microendoscope system) and not an AI or algorithm-based device that would require a training set. The document explicitly states, "No clinical tests performed." |
| How the ground truth for the training set was established | Not applicable, as this is a medical instrument (laparoscope/microendoscope system) and not an AI or algorithm-based device that would require a training set. The document explicitly states, "No clinical tests performed." |
Further details from the document:
- Study (or lack thereof): The document explicitly states in section 6.0, "Clinical Tests: No clinical tests performed."
- Performance Data: Section 5.0, "Performance Data," states: "Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving." This indicates engineering/functional testing was done, but no clinical performance data is provided or referenced, nor are specific acceptance criteria for these functional tests detailed.
- Conclusion: The conclusion drawn (Section 7.0) is that the devices are "substantially equivalent to existing devices on the market" and "They have been tested to allow safe usage with no significant changes during the standard lifetime when used according to instructions." This reinforces the focus on functional testing and substantial equivalence rather than a clinical performance study against specific 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.