Search Results

General surgery.

The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.

MIS Electrosurgical Electrode

The provided document is a 510(k) clearance letter from the FDA for an electrosurgical electrode. It states that the device is substantially equivalent to legally marketed predicate devices. This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details about experts used for ground truth establishment.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results from a standalone algorithm performance study.
7. The type of ground truth used in any study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document indicates that the device's indications for use are "General surgery" and that it is "intended to cut and coagulate tissue during minimally invasive surgical procedures" when used with an electrosurgical generator. The FDA's determination of substantial equivalence is based on a comparison to predicate devices, which implies that the device is expected to perform similarly to those already on the market, but the specific performance metrics and acceptance criteria for that comparison are not detailed in this letter.

Ask a specific question about this device