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The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.).

The provided document pertains to a 510(k) premarket notification for a medical device, the Erbe ESU Model VIO® 3 with Accessories. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance acceptance criteria through clinical studies in the same way a PMA or a de novo submission might.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or how ground truth for training sets was established. These details would typically be found in clinical study reports or more extensive technical documentation, which are not part of this 510(k) summary.

Instead, the document highlights:

• Intended Use: "The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue."
• Substantial Equivalence: The submission claims the device is substantially equivalent to the predicate device, Erbe ESU Model VIO® 300 D with Accessories (K083452).
• Verification/Validation Activities: These activities focused on meeting recognized standards, including electrical safety (e.g., IEC 60601 series), software lifecycle (IEC 62304), usability (IEC 62366, IEC 60601-1-6), sterilization information (IEC 17664, AAMI ST81), and biological evaluation (ISO 10993-1).
• Performance Evaluations/Testing:
  • Output/Mode Comparison
  • Tissue Testing
  • Contact Quality Monitoring (CQM)
  • Capacitive Coupling (per Standard Number 60601-2-2)
  • Accessory Testing

These performance evaluations were likely bench or pre-clinical tests designed to show that the device performs as intended and similarly to the predicate device, but the specifics of acceptance criteria for these tests and their results in a tabular format are not provided in this summary.

In summary, the document does not provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as such detailed performance data is generally not part of a 510(k) summary that focuses on substantial equivalence.

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