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The LAP-Pump PP110 is a suction and irrigation pump intended for use during diagnostic and or therapeutic laparoscopic procedures to irrigate fluid into and remove fluid from the abdominal cavity.

The LAP-Pump PP110 is a suction and irrigation pump for use during laparoscopic procedures. The irrigation and suction functions are used to facilitate the removal of debris and fluids during laparoscopy. The pump consists of the following main components: : (1) a power supply, (2) a power switch, (3), a START/STOP button for the irrigation function, (4), a START/STOP button for the suction function, (5) a roller wheel, (6) a pump head, (7) suction pump and (8) a casing. The pump is a microprocessor controlled single roller pump that functions according to the peristaltic principle and is to be used with specially designed sterile, single use irrigation tube sets with or without hand piece, a sterile outflow tube set and a vacuum tube set. The pump is designed to be mounted on a pole/tripod, or can be placed in an equipment rack.

This is a 510(k) premarket notification for the LAP-Pump PP110, a suction and irrigation pump for laparoscopic procedures. The document asserts substantial equivalence to predicate devices based on similar intended use, basic technological characteristics, and performance testing.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Test results demonstrate that the proposed device conforms to the above standards" and "Design verification testing of the LAP-Pump PP10 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness."

The "performance data" section focuses on compliance with various international standards for medical devices and sterility.

Here's a summary of the reported device performance in relation to the standards it aims to meet:

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