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The CML™ is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to intravascular administration set. The CML 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).

The Closed Male Luer is a normally closed two-way luer activated valve. Within the housing of the Closed Male Luer is a spring-loaded poppet whose head is flush with the male luer of the device. The poppet has an outer diameter that is smaller than the inner diameter of the housing. O-rings are positioned between the housing and poppet that form a physical seal between the poppet and the inner wall of the housing. The fluid pathway is opened when a female luer engages the male luer of the device. The female luer will push the poppet from its normally closed position, allowing fluid to flow freely to the female luer. The device at this stage is considered in the "open position". With the device in the open position, fluids can be injected or withdrawn. The O-rings maintain contact with the inner wall of the housing and the poppet at all times preventing fluid from flowing past the O-rings. Once the female luer connector is removed from the device, the spring-loaded poppet is allowed to return to the "closed position".

The provided text is a 510(k) summary for a medical device called "CML™" (Closed Male Luer). It establishes substantial equivalence to a legally marketed predicate device, the "Clave Connector K970855." This document does not describe an acceptance criteria table or a study proving that the device meets specific performance criteria. Instead, it focuses on demonstrating that the new device has similar technological characteristics and intended use as an existing cleared device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions regarding acceptance criteria, reported device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not addressed in this type of regulatory submission summary.

The document is a 510(k) summary, which is a regulatory submission for medical devices to demonstrate substantial equivalence to a predicate device, not a performance study report.

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