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The ERBE ESU Model VIO 100 C with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of issue.

The ERBE ESU Model VIO 100 C is a Generator that uses High Frequency (HF) electrical current waveforms to cut and/or coagulate tissue. It has a display as well as various cutting and coagulation modes to provide the physician standard modalities in interventional applications (i.e. its ability to generate the HF current). The System has an automatic start feature. The equipment is programmable and various accessories (e.g. footswitches, hand instruments, etc.) as well as modes may be assigned to perform specific functions. When activated, the Device has an audio as well as a visual erroring system (i.e. malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered.). The Unit is supplied non-sterile and is reusable.

Designated Footswitches have been developed for use with the ERBE ESU Model VIO 100 C. A Footswitch provides the physician a means to activate a mode of the ESU by depressing a foot pedal. There is a choice of two different types of Footswitches as follows: VIO C One (Single) Pedal Coag Footswitch (Note: Activates coagulation mode.) VIO C Two (Dual/Double) Pedal Footswitch (Note: Activates respectively cut and coagulation modes.)

This document is a 510(k) premarket notification for a medical device, the ERBE ESU Model VIO 100 C with Accessories. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced safety or effectiveness through extensive clinical trials. Therefore, the information provided does not align with the typical structure of a study proving a device meets specific acceptance criteria based on performance data.

Instead, the document asserts substantial equivalence based on similarities in intended use, principles of operation, and technological characteristics, while highlighting differences that do not raise new safety or efficacy concerns.

Based on the provided text, here's a breakdown of what can and cannot be answered regarding acceptance criteria and a study:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) notification focuses on comparing the new device to a predicate device rather than presenting specific quantitative acceptance criteria and then demonstrating the new device's performance against those criteria. The document states "all the changes were verified or validated," but it does not detail what those validations entailed or specific performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the document. This type of detail would typically be found in a study report, which is not part of this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the document. No "test set" or "ground truth" establishment by experts is mentioned, as this is not a clinical study designed to evaluate diagnostic or treatment accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document. As there is no mention of a test set or expert evaluation for ground truth, no adjudication method is discussed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/provided in the document. The device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided in the document. The device is an electrosurgical unit, not an algorithm. Its operation inherently involves a human operator (physician) in the loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the document. As this is not a study assessing diagnostic accuracy or treatment efficacy against a specific "ground truth," this concept is not discussed. The evaluation instead focuses on confirming that the modified device functions as intended and safely.

8. The sample size for the training set:

This information is not provided in the document. The device is a hardware electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in the context of this submission. Device "verification or validation" refers to engineering and performance testing, not model training.

9. How the ground truth for the training set was established:
This information is not provided in the document, as there is no "training set" for this type of medical device submission.

Summary of the "Study" (or rather, the basis for substantial equivalence):

The document describes a Special 510(k) Notification for the ERBE ESU Model VIO 100 C. This submission method is used when modifications to a legally marketed device do not significantly alter its safety or effectiveness. The "study" in this context is the comparison to the predicate device (ERBE VIO ESU, Model VIO 200 S, K080715) to establish substantial equivalence.

• Key points of the "study"/comparison:
  • Similarities: Same intended use (cutting/coagulation of tissue), same basic accessories, Monopolar, Bipolar, and Neutral Electrode Receptacles, same available modes (Auto Cut, Soft Coag, Forced Coag, Bipolar Soft Coag), user interface displays, programmable with Auto Start feature (Bipolar Soft Coag Mode), audio and visual error monitoring, manufactured in Germany as non-sterile and reusable, similar packaging and labeling.
  • Differences (and justification that they do not raise new safety/efficacy concerns):
    • Basic Model: Lighter, smaller, designed for tabletop use, intended as a more cost-effective system.
    • Neutral Electrode Monitoring System: Does not monitor current density and symmetry of a split return electrode but monitors pad connection and skin contact with a split return electrode. This is deemed adequate and industry standard due to the modified unit's lower power.
    • Less Programming Capabilities: Four program possibilities vs. nine for the predicate, making it "less complicated."
    • Lower Wattage: 100 watts max vs. 200 watts. Justified as "adequate" with many ESUs on the market having

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