(32 days)
For use with electrosurgical generators that have the accessory finger tip activation feature to control bleeding through the use of suction and cautery.
The monopolar electrosurgical device consists of an electrically conducting cannula which has plastic electrical insulation on it's exterior surface. This cannula fits into a plastic handle that has a central axial passage in line with the suction hole of the cannula. This suction hole leads to a suction hose fitting molded into the aft end of the handle. During use a hose connected to an external suction source is connected to the handle's suction fitting to provide suction to the cannula. A bleed hole in the handle allows the surgeon to control the amount of suction with his fingertip. High frequency power is supplied to the device through a 10 foot long power cord which enters the aft end of the handle and is internally connected to the cannula and switching circuitry. The distal end of the power cord has a standard plug that fits into most electrosurgical generators that have the accessory fingertip control option. The surgeon activates the cautery tip by pressing a push button located near the suction bleed hole. The new device will be marketed in cannula french size 10 with a 6 inch length.
The provided text is a 510(k) summary for an electrosurgical suction tube. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study.
Instead, the document focuses on the general safety and effectiveness of electrosurgery, referencing a bibliography of articles. It states that the device "meets all applicable requirements of this standard" (ANSI/AAMI HF18-1993) to assure safety, but it does not provide specific acceptance criteria or data from tests conducted on this particular device to demonstrate that it meets the standard. It implies that due to the well-documented nature of electrosurgery, detailed performance studies for this specific device are not being presented in the summary.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document is a submission for a 510(k) premarket notification, which often relies on demonstrating substantial equivalence to a predicate device rather than extensive new clinical efficacy or performance studies. The safety and effectiveness claims are broadly supported by the established knowledge and standards for electrosurgery, rather than specific studies on this individual device's performance against defined acceptance criteria.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.