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The device is intended for use in all types of endoscopic and endoscopic assisted procedures.
The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.

The Vista Single Chip Video Camera is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.

The provided text describes a 510(k) submission for the Vista Single Chip Video Camera System. It outlines the device's intended use, predicate devices, and compliance with safety standards. However, it does not contain the detailed performance data, acceptance criteria, or study descriptions needed to fully answer your request regarding acceptance criteria and a study proving device conformance.

The "PERFORMANCE DATA" section only lists the standards the device was designed to comply with (IEC 601-1, IEC 601-1-2, UL544) and mentions "Optical Test Data" without providing any details about the tests, their results, or acceptance criteria.

Therefore, for most of your questions, the answer will be that the information is not provided in the given text.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not provided.
• Data Provenance: Not provided.

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/not provided. This type of device (a video camera) typically relies on objective performance measurements rather than expert consensus on medical image interpretation for its primary safety and effectiveness evaluation for 510(k) purposes.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC study was not described or implied. This type of study is more relevant for diagnostic AI algorithms rather than a medical imaging device itself.
• Effect Size of Human Readers Improvement: Not applicable.

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

• Standalone Performance Study: Not described in the text. The "Optical Test Data" mentioned could refer to some form of standalone performance, but no details are given. The device is a video camera, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. For a video camera, "ground truth" would likely relate to objective optical and electrical performance characteristics measured against engineering specifications, rather than medical interpretations.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device is a hardware video camera, not an AI algorithm that undergoes "training."

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

• Ground Truth for Training Set: Not applicable. The concept of a "training set" and "ground truth" for training does not apply to this type of device.

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