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The electrosurgical instruments are intended to remove tissue and control bleeding.

The various unipolar and bipolar Micro-France electrosurgical instruments consist of scissors, forceps, and probes, and are available in configurations for laparoscopic / endoscopic access and open field surgery. Accessories include unipolar and bipolar cables available in lengths up to 3 M.

The provided text is a 510(k) summary for electrosurgical instruments. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on acceptance criteria and performance of the new device.

Therefore, the input does not contain the information necessary to describe:

• Acceptance criteria table and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily states the device's intended use ("to remove tissue and control bleeding") and identifies predicate devices that it claims substantial equivalence to. It does not provide performance metrics, study designs, or data related to demonstrating the device meets specific acceptance criteria in the way a clinical or performance study report would.

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