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Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

The MSI SA series of disposable electrodes are electrosurgical devices used for coagulation of soft tissue. These devices are designed for percutaneous, laparoscopic or intraoperative use. The device consists of a needle electrode and a handle. For temperature measurement model, the needle contains a thermocouple for monitoring tissue temperature. The needle electrode is housed in an insulated cannula. The handle incorporates an electrical connector for interconnecting to an electrosurgical generator.

The provided text is a 510(k) summary for the MSI SA Electrodes, which is an electrosurgical device. This document focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics, and therefore describes performance testing rather than a study with acceptance criteria in the context of clinical AI/ML device evaluation.

The 510(k) summary explicitly states: "Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI SA Electrode is substantially equivalent to predicate device and is safe and effective in its intended use."

However, it does not provide the specific details required for the requested table and study information, such as:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not mentioned, as it primarily refers to performance testing, not a clinical study on a test set.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no clinical ground truth determination described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No indication of an MRMC study. The device is an electrosurgical tool, not an AI/ML diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable; the "ground truth" would likely be based on engineering specifications and physical performance tests for an electrosurgical electrode (e.g., coagulation efficacy, temperature accuracy, insulation integrity).
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is for a physical electrosurgical device and focuses on demonstrating substantial equivalence through performance testing, which is a different type of validation than the one typically described for AI/ML-based medical devices with specific acceptance criteria, clinical test sets, and expert-established ground truths. Therefore, the requested information elements are largely not present or applicable in this context.

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