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Bidirectional needleless injection valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or for withdraw of fluids through the artery. Bidirectional needleless injection valve may be used with low-pressure power injectors with a flow at 10 ml/s, in state of connection.

The CAIR LGL valves features include a smooth swappable septum surface, septum seal integrity with no gaps or openings, a microbial physical barrier, straight through fluid pathway, zero dead space, zero fluid displacement low priming volume, saline-only flush option and no clamping sequence or positive pressure syringe technique required.
The Cair bidirectional needleless injection valve may be used with low pressure power injectors having a pressure of 7 bars with a luer lock connection.
The subject device is composed of materials (polycarbonate, silicone) that have been successfully and safely used in medical devices including the predicate device. The materials used in the subject device have been subjected to and passed biocompatibility testing.

This document describes the 510(k) summary for the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear). It does not contain information about a study proving that the device meets acceptance criteria via performance metrics as would typically be found for AI/ML-enabled devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and conformity to various standards.

Therefore, many of the requested sections related to AI/ML device studies, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or inferred from the provided text, primarily regarding non-clinical testing for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The document states: "Testing conducted, that reference the design verification and validation testing of the Cair bidirectional needleless injection valve (Cair Drive and Neutraclear), meets predetermined acceptance criteria for the device." However, the specific acceptance criteria and the quantitative performance results are not detailed in this summary section beyond general statements of meeting criteria. The types of tests performed are listed, implying that the device "meets predetermined acceptance criteria" for each of these:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as this is a traditional medical device (not AI/ML) and the document describes non-clinical engineering and biological tests rather than studies with patient data. No sample sizes are specified for the non-clinical tests conducted. The submitter is CAIR L.G.L. from France.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" here would be established by validated test methods and standards for the non-clinical tests (e.g., ISO standards for sterility, biocompatibility, leak rates), not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for expert review of clinical cases. For non-clinical tests, conformance to specified test protocols and standards dictates success or failure.

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 not an AI/ML diagnostic or assistive tool, so MRMC studies are irrelevant.

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

Not applicable. This device is a passive mechanical component, not an algorithm.

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

For the non-clinical tests, the "ground truth" is defined by established international standards (e.g., ISO, 21 CFR) and their specific pass/fail criteria for each test (e.g., sterility, leak rates, biocompatibility).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

9. How the ground truth for the training set was established

Not applicable.

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