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The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The ERBE ESU Model VIO 300 D with Accessories is an electrosurgical system that uses High Frequency (HF) electrical current waveforms to cut and/or coagulate tissue. There are modifications made to only a few of the Accessories from the previously cleared 510(k) Number K023886 and they are included within this submission.

The ESU has a color monitor display that provides the user with an on-screen tutorial as well as settings and operational information. The unit has various cutting and coagulation modes with defined effect levels to provide the physician flexibility in interventional applications (i.e. its ability to generate HF current). The system has automatic start and stop features. 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 and visual error 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). Upon activation, the energy delivered (in watts) from the ESU to the tissue is displayed on the display screen.

Also, the Unit can be used in association with an ERBE compatible Argon Plasma Coagulator (APC). The ESU is supplied non-sterile and is reusable.

Various types of single and double pedal Footswitches have been designed for ESU VIO Models. The Footswitches are used to activate the Generator. Some of the Footswitches have a ReMode button so that the physician can toggle between preset programs. Also, some Footswitches are equipped with a bracket (i.e. bar) so that the operator can position their foot.

The provided document is a 510(k) summary for the ERBE ESU Model VIO 300 D with Accessories. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study results for novel devices.

Therefore, the document does not contain the detailed information requested in your prompt regarding acceptance criteria, specific device performance measurements, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies.

The submission focuses on comparing the modified device to its predicate device (ERBE VIO ESU Model VIO 300 D) and demonstrating that the modifications do not raise new safety or efficacy concerns.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.

• Reported Device Performance: No specific quantitative performance metrics are provided beyond stating that "All of the modifications (i.e., additions and changes) for the ERBE ESU Model VIO 300 D with Accessories have been verified or validated in design control." This general statement confirms that the device was tested to perform as intended, but no detailed results or numerical performance values (e.g., accuracy, precision, output consistency) are included in this summary.

  Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
  Device has the same intended use, principles of operation, and technological characteristics as the predicate devices.	The ERBE ESU Model VIO 300 D with Accessories has the same intended use, principles of operation, and technological characteristics as the predicate devices.
  Modifications do not raise additional safety or efficacy issues compared to predicate devices.	All modifications have been verified or validated in design control. No issues raise additional safety or efficacy concerns.
  All changes and additions as necessary are reflected in the labeling.	All changes and additions as necessary are reflected in the labeling.

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable/Not Provided: This document describes a 510(k) submission for an electrosurgical unit, not an AI/ML-based device that would typically involve test sets of data for performance evaluation in the way your prompt describes. The "testing" referred to is design control verification and validation (e.g., electrical safety, electromagnetic compatibility, functional testing of specific features), not performance on a diagnostic dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable/Not Provided: As this is not an AI/ML diagnostic device, there is no "ground truth" in the context of expert consensus on medical images or similar data. The device's functionality is verified against its engineering specifications and the intended physiological effects, not against expert interpretations of data.

4. Adjudication Method for the Test Set:

• Not Applicable/Not Provided: No adjudication method is mentioned as there isn't a test set of data requiring expert review and consensus.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No: This document does not mention any MRMC study, as it's not a diagnostic device where human reader effectiveness with or without AI assistance would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes (Implicit for Electrosurgical Unit Functionality): The device (ERBE ESU Model VIO 300 D) itself, as an electrosurgical generator, has "standalone" functional performance. Its ability to generate HF current, operate in various modes, display information, and implement safety features is tested independently during design validation. However, this is not a "standalone algorithm" performance in the AI/ML sense. The studies done are typical engineering verification and validation testing for medical devices (e.g., power output accuracy, current delivery, safety mechanisms like NESSY, error detection).

7. Type of Ground Truth Used:

• Engineering Specifications and Functional Requirements: The "ground truth" for an electrosurgical unit involves its ability to consistently and safely deliver specific electrical waveforms and power outputs according to its design specifications, national/international standards (e.g., IEC 60601), and the intended physiological effect on tissue (cutting/coagulation). This is established through rigorous engineering testing, not pathology or outcomes data in the sense of a diagnostic test. For example, validating output power at different resistances would be part of this.

8. Sample Size for the Training Set:

• Not Applicable/Not Provided: There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable/Not Provided: No training set exists.

In summary: The provided document is a regulatory submission focused on substantial equivalence for a medical device (electrosurgical unit) based on design modifications and engineering verification/validation, not clinical study data for a diagnostic AI/ML system. Therefore, most of the detailed information requested in your prompt regarding acceptance criteria and study methodologies, particularly those related to AI/ML device evaluation, is not present.

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