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The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall.

The VasoView™ Balloon Dissection System is a single-use device which consist of a, tubular body with a distal transparent conical tapered tip, an elastomeric balloon adjacent to the tapered tip, luer extension, and syringe. It is designed to accept a 5mm diameter rigid endoscope for visualization through the tapered tip. The VasoView™ Balloon Dissection System is provided sterile This dissection cannula is used to advance along specific anatomic tracts to isolate structures. After the cannula advancement, sequential balloon inflation forms an elongated cavity in the desired location.

The provided text does not contain information related to software or AI/ML device performance, acceptance criteria, or a study evaluating such a device. The document is a 510(k) summary for a physical medical device called VasoView™, a balloon dissection system.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets those criteria, as the information is not present in the provided context for an AI/ML device.

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