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The GeniCon Pnutemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The GeniCon, Pneumo-Needle is a sterile, disposable Veress needle which is available in 120mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a malue luer lock connector for secure CO2 gas line connection.

The provided text describes a 510(k) premarket notification for the GeniCon Pneumo-Needle. This device is a sterile, disposable Veress needle intended for insufflation with carbon dioxide to establish pneumoperitoneum during laparoscopic procedures. The documentation focuses on demonstrating substantial equivalence to a predicate device and outlines performance tests conducted, but it does not include a study or detailed acceptance criteria for an AI/CADe device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/CADe device, a study proving it meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.

The "Performance" section explicitly states:

Performance:
A series performance tests were performed on the GeniCon Pneumo-Needle to inspect such areas as:

• Tip Pull Test
• Switch Operation
• Spring Obturator Operation
• Needle Puncture Force Test

These are mechanical performance tests for a physical medical device, not a study evaluating algorithm performance or clinical effectiveness in the context of AI/CADe.

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