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The Needleless Injection Site is intended to provide additional protection against inadvertent "neeedlestick" injuries to health care providers during the administration of fluids and medications. The Needleless Injection Site provides for the entry to an intravascular administration set or catheter without the need of a sharp needle by allowing for the use of a blunt cannula.

The BEC Needleless Injection Site consists of a tubular body with a male luer lock attachment at one end. This attachment is designed to connect to a female luer lock or luer slip connector of a catheter or other intravascular administration device. The other end of the tubular body is provided with an enlarged section adapted to receive a cylindrical retaining ring which surrounds and compresses a pre-slit, natural rubber septum. The septum retaining ring and enlarged section of the tubular body are adapted to receive and latch with the BEC, MED-NET, or IMED shrouded plastic cannula. The pre-slit septum re-seals upon removal of the cannula.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a "BEC Needleless Injection Site," focusing on its description, intended use, and substantial equivalence to previously cleared devices.

Here's a breakdown of why I cannot fulfill your request with the given input:

• No Acceptance Criteria or Performance Data: The document states, "Technological data and performance data were submitted for the IMED predicate device." However, it does not provide those data or list any specific acceptance criteria for the BEC Needleless Injection Site itself. It
  relies on the substantial equivalence to a predicate device (IMED Corporations Needleless Injection Site submitted under 510(k) #K944320) which had such data submitted.
• No Study Details: Since performance data or acceptance criteria are not presented, there are no details about any study (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set) to evaluate.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided text.

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