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The ERBE VIO ESU with Accessories is intended to deliver high frequency electrical current for the cutting and/or coagulation of tissue.

The ERBE VIO ESU with Accessories is an electrosurgical system that uses high frequency (hf) electrical current waveforms to cut and/or coagulate tissue.

This looks like a 510(k) premarket notification for an electrosurgical generator (ESU). These types of submissions typically focus on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting a traditional clinical study with acceptance criteria and device performance metrics in the way a novel drug or a high-risk software-as-a-medical-device (SaMD) would.

The document describes modifications to an existing device, the ERBE VIO ESU (Model VIO 300 D) with Accessories, and compares it to a predicate device, the ERBE ERBOTOM ESU (Model ICC 350 E). The primary goal is to show that the new device is as safe and effective as the predicate device.

Therefore, many of the requested categories for a "study proving device meets acceptance criteria" are not directly applicable or are interpreted differently in this context.

Here's an attempt to extract and interpret the information based on the provided text, noting where a direct answer isn't available due to the nature of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of this nature, "acceptance criteria" are implied by demonstrating that the modified device performs similarly or equivalently to the predicate device in its intended function. The "performance" is described through the features and capabilities of the modified ESU compared to the predicate.

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

• Sample Size: Not applicable in the context of a 510(k) for an ESU. This submission relies on engineering verification and validation of modifications against a predicate device, not statistical sampling of cases.
• Data Provenance: The device is manufactured by ERBE Elektromedizin GmbH in Germany. The "data" here refers to design control documentation, engineering tests, and comparisons to the predicate, rather than patient outcomes or image data. The report implies the evaluation is based on internal verification/validation processes. This is retrospective in the sense that it's a review of design and testing documentation before market entry.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: Not applicable. Ground truth, in the sense of clinical interpretations or diagnoses, is not established for this type of device submission. The "truth" is whether the device performs its intended electrosurgical functions safely and effectively, which is assessed through engineering and performance testing.
• Qualifications of Experts: The document mentions "feedback from doctors" for the inclusion of larger voltage spreads and more effect levels (Section {3}). This indicates clinical input during the design process, but not expert adjudication of a test set for performance evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The assessment is based on physical and electrical performance verification and validation.

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

• MRMC Study: Not applicable. This device is an electrosurgical generator, not an AI-powered diagnostic or interpretive tool that assists human readers.

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

• Standalone Performance: Not applicable. This device is an electrosurgical generator, not an algorithm. Its operation inherently involves a human operator (the physician) selecting modes and applying electrical current.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this 510(k), the "ground truth" is the established performance and safety of the legally marketed predicate device (ERBE ERBOTOM Model ICC 350E). The modified device's performance is accepted if it is shown to be substantially equivalent in safety and efficacy to this predicate. This is demonstrated through engineering design control, verification, and validation activities (e.g., electrical performance testing, tissue effect testing, safety testing, and software validation).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses training sets.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As above, this is not an AI/machine learning device.

Summary for a 510(k) of an Electrosurgical Generator:

The "study" that proves the device meets acceptance criteria in a 510(k) context for an ESU is the design control process, including verification and validation activities, which demonstrate that the modified device is substantially equivalent to a legally marketed predicate device. This involves:

• Bench testing: Verifying electrical outputs (voltage, current, power) across various modes and effect levels.
• Performance testing: Demonstrating anticipated tissue effects (cut, coagulation) under controlled conditions.
• Safety testing: Ensuring compliance with relevant electrical safety and electromagnetic compatibility standards.
• Software validation: For the embedded software that controls the device and its display features.
• Comparison to Predicate: A direct feature-by-feature and performance-by-performance comparison to the predicate device to argue for substantial equivalence.

The document explicitly states: "All the unit modifications have been verified or validated in design control." and "All the modifications of the components have been verified or validated in design control." This statement is the "proof" the FDA looks for in such a submission. The "acceptance criteria" are implicitly met if substantial equivalence to the predicate is demonstrated through these activities, meaning the device is as safe and effective as a device already on the market.

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