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The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.

The IVAC Needle Free Valve administration sets incorporate standard IVAC set components using standard materials. The sets include a needle free valve that allows the user to add medication into the primary line without the use of a needle. When the valve is in the closed position it has a flat smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve the rubber piston inside the valve is compressed. The top of the rubber piston is then allowed to expand into the increased diameter inside the valve. Fluid path is achieved through the male connector into the center of the rubber piston and the valve housing. When the male connector is removed from the valve, the bellows section of the piston provides a spring force to return the piston to the top of the valve and to maintain a sealed fluid path. A cap is not required to maintain sterility.

This 510(k) premarket notification for the IVAC Needle Free Valve Administration Sets describes a medical device and its substantial equivalence to a predicate device, the ICU Medical, Inc. Clave Connector. However, it does not contain information about specific acceptance criteria, device performance metrics, or any studies designed to prove the device meets such criteria.

The submission focuses on demonstrating substantial equivalence based on technological characteristics, intended use, and materials. It does not provide the kind of detailed performance study information typically required for describing acceptance criteria and a study proving their fulfillment in the context of device performance, as outlined in your request.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: No such table or performance data is presented.
2. Sample sized used for the test set and the data provenance: No test sets or study data are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment or expert involvement is mentioned.
4. Adjudication method for the test set: No test sets or adjudication are described.
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: This device is not an AI-driven diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an algorithmic device.
7. The type of ground truth used: No ground truth is discussed.
8. The sample size for the training set: This is not an AI/machine learning device; no training set exists.
9. How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission for substantial equivalence based on material and functional similarity to an existing device, not a performance study report with detailed acceptance criteria and testing results.

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