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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days, when used as intended.

The ProSeal™ CSTD devices are single-use, sterile, non-pyrogenic CSTD component devices that are fitted to each other. They are used as sterile interfaces for the closed injections and withdrawals of liquids into and from the ProSeal™ CSTD component devices and external transfer devices. The ProSeal™ In Line Pump Set is a closed system in-line IV infusate/drug transfer adapter/ connector for providing closed system protection during hazardous drug administration when connected to a standard IV set at its distal end, with the proximal end attached to a mating ProSeal™ Injection Site (K240433) of a ProSeal™ CSTD component device such as the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442).

This document does not contain the information required to populate a table of acceptance criteria and reported device performance for a medical device that would involve AI or machine learning. The provided text is a 510(k) summary for a physical medical device (ProSeal™ In Line Pump Set), which is an intravascular administration set, and does not mention any AI components, software, or algorithms.

Therefore, questions related to:

1. Acceptance criteria and reported device performance (with AI metrics)
2. Sample size for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study and effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used (for AI)
8. Sample size for the training set
9. How ground truth was established for the training set

cannot be answered from the provided text.

The document focuses on the substantial equivalence of the ProSeal™ In Line Pump Set to a predicate device (ProSeal™ Injector Plus) based on:

• Intended use and indications for use
• Technological characteristics (materials, design, sterilization, shelf-life)
• Performance data from bench testing demonstrating compliance with ISO standards for mechanical, fluidic, and safety aspects.
• Biocompatibility testing (per ISO 10993)
• Sterility, shipping, and shelf-life testing.

The performance data listed pertains to physical device attributes such as leak integrity, flow rate, Luer lock connection tests, sharps injury protection, needle bonding strength, resistance to temperature/pressure/dropping, water vapor impermeability, spiking port ability and adhesion, particulate non-contamination, and impermeability to microorganisms. These are standard engineering and biomedical tests for physical medical devices, not performance metrics for AI algorithms.

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