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Single use, sterile device for preparation of drugs in a standard luer syringe to transfer the prepared drug back into the syringe for delivery.

The E-Z-Link device is a sterile, single use device that, through the use of a stainless steel cannula (needle), facilitates creation of a sterile fluid path to transfer liquid from a standard luer lock syringe to a standard pharmaceutical 13 mm vial containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the luer lock syringe for delivery. The product line will include devices with different gauge transfer needles (20 and 27 Gauge).

The E-Z-Link device is a sterile, single-use vial adapter/reconstitution device. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and performance testing. It does not describe a study involving a test set, ground truth, or expert readers in the context of typical AI/diagnostic device evaluation.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The regulatory submission for the E-Z-Link device focuses on demonstrating that its performance characteristics meet established standards for similar devices. The "acceptance criteria" are implied by the successful completion of the listed tests, indicating the device meets the functional, safety, and quality requirements.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of evaluating an AI or diagnostic algorithm on a specific dataset of cases. The performance data refers to physical and biological testing of the device itself. Therefore, information about sample size and data provenance for a test set is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes physical device testing, not a study evaluating human or AI performance against a ground truth from experts.

4. Adjudication Method for the Test Set

This information is not applicable.

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

An MRMC study is not applicable to this type of device (a mechanical vial adapter). The document does not describe any human reader performance evaluation or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The E-Z-Link is a manually operated mechanical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The concept of "ground truth" as typically used in diagnostic imaging or AI studies is not applicable here. For mechanical devices like E-Z-Link, the "ground truth" is defined by adherence to engineering specifications, international standards (e.g., ISO), and accepted medical device performance parameters for safety and functionality. For example, for "Leak Testing of connections per ISO 594-1," the "ground truth" is the specified leak rate threshold outlined in the ISO standard.

8. The Sample Size for the Training Set

This information is not applicable. The E-Z-Link is a mechanical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable.

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