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To inflate and deflate an angioplasty balloon or other interventional device and when equipped with a gauge, to monitor the pressure within the balloon.

The Viceroy Inflation Device is a manually-controlled inflation device clinicians use to inflate and deflate an angioplasty balloon. The device is composed of a handle or know which the clinician manipulates to achieve the desired pressure. The bandle is connected to a threaded plunger which provides for incremental pressure regulation of the syringe barrel. A locking mechanism is incorporated to maintain a constant pressure without direct user effort. The syringe barrel allows for the storage of desired pressurization rates and its walls are transparent for syringe barrel content visualization. In most Viceroy configurations an analog gauge is available for neasuring barrel pressure and the gauged devices are connected to high pressure tubing which terminates in a rotating male lucr lock connector. The non-gauged devices also terminate in a rotating male luer lock connector.

The provided text is a 510(k) premarket notification for the Viceroy Inflation Device. It describes the device, its intended use, and states that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not describe a study that proves the device meets specific acceptance criteria in the manner requested.

Specifically, the document states:

• "Merit has performed a series of comparative mechanical tests to support a substantially equivalent determination and to demonstrate the device's safe and effective performance when used as intended."
• "The performance data indicate that the applicant and the predicate devices have substantially equivalent values. They also indicate that the design of the applicant device is sufficiently robust for its intended use."
• "The Viceroy Inflation Device has met all acceptance criteria."

While these statements confirm that tests were done and criteria were met, the document does not provide the detailed information requested about those acceptance criteria, the specific test results, sample sizes, data provenance, expert involvement, or any information about multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot populate the table and answer the specific questions because the detailed information is not present in the provided text. The document focuses on regulatory approval based on demonstrating substantial equivalence, rather than a detailed breakdown of a specific clinical or performance study with published results.

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