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The BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and nonhazardous drugs when pared with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ Needle-Free Syringe/ SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free).

The BD Texium™ Needle-Free Syringe is a single use piston syringe that consists of a syringe (3mL, 5mL, 10mL, 20mL, 30mL, or 50mL) permanently bonded to a closed male luer device (BD Texium™ Closed Male Luer, K223076). The Texium" Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all phases of drug handling when the BD Texium™ Needle-Free Syringe is used in conjunction with the SmartSite™ Needle-Free Connector: the preparation of the drug, the administration of the drug to the patient, and waste handling. The BD Texium™ Needle-Free Syringe is a passive device – it requires no cap and automatically seals upon disconnection.

The BD Texium™ Needle-Free Syringe has a unique closed male luer connector that is intended to be used with the currently marketed BD SmartSite™ Needle-Free Connector. As with the predicate device, the male luer design of the BD Texium™ Needle-Free Syringe includes an internal mechanism that causes the luer to seal when disconnected from a female luer. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. When used with the BD SmartSite" Needle-Free Connector, the BD Texium™ Needle-Free Syringe is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy drugs. Furthermore, the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside of BD Texium™ Needle-Free Syringe/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills (e.g., airtight, leak-free and drip-free).

The provided text describes the BD Texium™ Needle-Free Syringe and its substantial equivalence to predicate devices, but it does not include specific acceptance criteria or reported device performance in a format that allows for a direct table comparison for all requested metrics.

However, based on the Discussion of Non-Clinical Tests and Performance Testing sections, I can infer some of the tests performed and their general outcomes. The document states "All test results met their acceptance criteria," but does not explicitly list those criteria numerically. No training set information is provided as this is a non-AI/ML device.

Here's an attempt to answer your questions based on the available information:

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

The document does not provide a table with specific numerical acceptance criteria and reported performance for all aspects. Instead, it indicates that all tests met their acceptance criteria. Here's a summary of the mentioned performance testing, acknowledging the lack of specific numerical criteria in the provided text:

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

The document does not specify sample sizes used for any of the non-clinical tests.
The provenance of the data (country of origin, retrospective or prospective) is not mentioned. These are non-clinical (laboratory/bench) tests rather than clinical studies.

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)

This is not applicable as the document details non-clinical (bench/laboratory) testing for device performance and safety, not an AI/ML study requiring expert ground truth for interpretation.

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

This is not applicable for the same reason as point 3.

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

No MRMC study was mentioned or performed. This document describes non-clinical testing of a physical medical device (syringe), not an AI-assisted diagnostic tool.

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

This is not applicable as there is no algorithm or AI component in this device.

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

The "ground truth" for the non-clinical tests described would be the established scientific and engineering standards and specifications (e.g., ISO standards, ASTM standards, USP chapters, internal specifications) against which the device's performance was measured. For example, for sterility, the ground truth is a Sterility Assurance Level (SAL) of $10^{-6}$.

8. The sample size for the training set

This is not applicable as there is no AI/ML component or a "training set" for this physical device.

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

This is not applicable as there is no AI/ML component or a "training set" for this physical device.

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