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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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The Smart-Rod™ is a single use reconstitution device intended for the transfer of a diluent contained in a prefilled syringe to a vial containing a drug product, and the return transfer of the admixture to the syringe.

The Smart-Rod™ is intended for use by physicians, nurses, and other practitioners who routinely administer injections, or patients and other individuals authorized by a physician to administer injections of prescribed medication.

The Smart-Rod™ is a single-use reconstitution device consisting of a preassembled vial socket and plunger rod. The Smart-Rod™ is designed to be used together with a pre-filled syringe. The pre-filled syringe would be legally authorized through its own clearance or customer New Drug Application and is not intended to be cleared as part of this premarket notification. The Smart-Rod™ plunger rod replaces the usual plunger rod of the pre-filled syringe and has an integral needle designed to perforate the plunger of the pre-filled syringe for fluid transfer from the syringe to the drug vial (connected using the vial socket) through the internal fluid path in the rod. Once reconstitution is complete, the device permits the transfer of the reconstituted drug product back to the syringe. The integral needle is retracted into the plunger rod by unscrewing the vial socket. The vial socket and vial are discarded, and the filled syringe containing reconstituted drug is ready for use and the drug product may be injected by means of the yet unexposed needle equipping the syringe.

The provided text describes a 510(k) summary for the Duoject Medical Systems Inc. Smart-Rod™ Reconstitution System. Here's a breakdown of the acceptance criteria and study information, based only on the provided text.

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific numerical acceptance criteria or detail the performance metrics against such criteria. It broadly mentions "16 qualification tests" to demonstrate operational performance.

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. The document only mentions "16 qualification tests" were conducted, but does not provide the number of devices tested for each or across all tests.
   • Data Provenance: Not specified. The country of origin of the data (e.g., Canada where the company is based, or another location) and whether the studies were retrospective or prospective are not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" concept, typically related to clinical image interpretation or diagnostic accuracy studies, is not relevant to this device, which is a reconstitution system and not a diagnostic device. The performance testing described is engineering/functional in nature.

3. Adjudication method for the test set:

   • Not applicable. As noted above, the testing described appears to be functional/engineering performance testing, not involving human interpretation or clinical adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. The device is a "reconstitution system" and the described "Performance testing" relates to its operational functions (e.g., attachment, interaction, integrity), not diagnostic effectiveness or human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a physical medical device (reconstitution system), not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. For this type of device (fluid transfer system), "ground truth" would likely refer to objective engineering measurements or successful completion of specified functional tasks according to predetermined criteria. The document states "16 qualification tests were conducted to demonstrate the operational performance," implying objective, measurable outcomes for these tests, but does not detail the nature of these "ground truths" or their establishment.

7. The sample size for the training set:

   • Not applicable. As the device is a physical reconstitution system and not an AI/ML algorithm, there is no "training set" in the conventional sense of machine learning.

8. How the ground truth for the training set was established:

   • Not applicable, for the same reasons as point 7.

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