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The Closed Male Luer (CML) is a single use, sterile, swab-able, bi-directional valve intended for use as an accessory to an Intravascular Administration Set. The Closed Male Luer provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter which is inserted into the vein or artery.

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The provided text is a clearance letter from the FDA for a medical device called "Closed Male Luer" and an "Indications for Use" statement. It does not contain the acceptance criteria or a study describing the device's performance against such criteria. The document explicitly states that the FDA's substantial equivalence determination does not mean the device complies with other requirements of the Act or any Federal statutes and regulations.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on presenting performance data.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a comprehensive market submission that includes performance testing results.

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