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Ergon-X-HF is an extraoral X-ray source system intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaws, and oral structures.

VIVI Ergon-X HF is a device made up of a mobile and articulate double support arm. At the opposite ends of the arm are located respectively:

• a central unit equipped with wall plate, extension and radio control device. This unit is the . interface on which the control panel is placed;
• . the tube head with X-Ray Tube.

The provided text describes the VIVI Ergon-X HF, an extraoral X-ray source system, and its 510(k) submission. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to the image quality or diagnostic accuracy of the device itself.

The "Performance Data" section primarily lists international standards the device was developed and tested according to. These standards relate to general safety, electromagnetic compatibility, radiation protection, and software life cycle processes, which are regulatory compliance requirements rather than acceptance criteria for diagnostic performance.

The text does mention a "comparative test was performed with the predicate device Endos DC (K030634) and this test demonstrated that the output to the patient is equivalent for both VIVI Ergon-X HF and Endos DC (K030634)." This is a comparison for patient output (likely radiation dose), not diagnostic performance.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text. I will indicate where the information is missing.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided text. The document lists regulatory standards the device complies with, but not specific performance acceptance criteria for diagnostic capability (e.g., resolution, contrast, accuracy of disease detection) or any reported device performance against such criteria.

2. Sample size used for the test set and the data provenance

This information is not available in the provided text. The document mentions a "comparative test" for patient output but does not specify sample size or data provenance (country of origin, retrospective/prospective) for any test related to diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available in the provided text. No details are given about any study involving expert review for establishing ground truth related to diagnostic performance.

4. Adjudication method for the test set

This information is not available in the provided text.

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/available. The VIVI Ergon-X HF is described as an "extraoral X-ray source system," which is a hardware device for generating X-rays for dental radiography. It is not an AI-powered diagnostic software, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this product description.

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

This information is not applicable/available. As a hardware X-ray device, it does not involve an algorithm with standalone performance in the context of diagnostic interpretation.

7. The type of ground truth used

This information is not available in the provided text. Since no diagnostic performance study is described, the type of ground truth is not mentioned.

8. The sample size for the training set

This information is not applicable/available. As a hardware X-ray device, it does not use a training set in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable/available. As a hardware X-ray device, it does not use a training set in the context of machine learning.

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