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SURTRON model devices (80D, 160, 200, FLASH 160 HF, 400 HP) are ElectroSurgical Units including monopolar and bipolar technology (excepts SURTRON 80D which delivers monopolar technology only). They are intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.

SURTRON model devices (80D, 160, 200, FLASH 160 HF, 400 HP) are ElectroSurgical Units including monopolar and bipolar technology (excepts SURTRON 80D which delivers monopolar technology only).

This document is an FDA 510(k) clearance letter for electrosurgical units. It details the substantial equivalence determination for the devices but does not contain information about acceptance criteria, device performance study results, or AI/ML components.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone (algorithm-only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The provided text focuses on regulatory approval, product codes, classifications, and general controls, not on the technical performance data typically found in a study report for a device's acceptance criteria.

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