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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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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.

EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor). The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.

The provided text includes a 510(k) summary for the EQUASHIELD™ System, a closed drug transfer system. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study design with reported performance metrics, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications as requested.

The document only states that:

• "A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance."
• "A simulated clinical test was performed in order to evaluate the Plastmed EQUASHIELD™ System and to ensure it performs its intended use as a closed drug transfer system. The simulated test has demonstrated that the EQUASHIELD™ system performs its intended use."
• "Both bench tests and simulated clinical test have shown that the device performs its intended use."

Without further details, it is impossible to populate the requested table and information points accurately.

Here's a breakdown of what cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: No specific quantitative or qualitative acceptance criteria are listed, nor are any performance metrics and their results reported. The document only offers general statements of "satisfactory performance" and "performs its intended use."

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing involves bench and simulated clinical tests, but it's unclear if "experts" were involved in establishing ground truth (e.g., for contamination assessment).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a closed drug transfer system, not an AI-assisted diagnostic or imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Again, this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For bench and simulated clinical tests, ground truth would typically refer to established standards or verifiable measurements of containment or drug transfer accuracy.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document only offers a high-level overview of performance validation, stating that tests were performed and results were satisfactory. It lacks the granular detail required to complete the requested information.

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