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The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

The EQUASHIELD™ Luer Lock Connector Pair is a closed system for drug transfer. It utilizes some of the predicate device components to create a closed system during drug transfer. The EQUASHIELD™ Luer Lock Connector Pair consists of a connector to an infusion set (Female Luer Lock Connector) and a connector to an IV catheter (Male Luer Lock Connector). The connector pair provides closed system protection during connection and disconnection of a fluid path, thereby prohibiting the escape of the hazardous drug and its harmful vapors into the environment by air-tight enclosing of air and all contaminants within the system.

The provided text describes a 510(k) premarket notification for the EQUASHIELD™ Luer Lock Connector Pair, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner one might find for an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically applied for AI/ML device studies, is not present in the provided text.

The document states:

• "Modified device verification and validation tests showed that it is as safe and as effective as the predicate device."
• "Test results support all labeling claims and substantial equivalency. The modified device was tested in accordance to Plastmed's legally marketed device specification. All testing results demonstrated satisfactory performances and met all acceptance criteria."
• "The evaluation of Plastmed's modified Device's bench tests demonstrated that the device performs as intended and that it is as safe and as effective as the predicate device."

However, it does not provide the specific acceptance criteria themselves, the reported performance against those criteria in a table, or any of the detailed study parameters (sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment methods) that you've requested. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence through non-clinical performance data and bench tests, rather than clinical efficacy studies.

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