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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 contaminants into the drug or fluid path for up to 168 hours or 7 days, when used as intended.

The ProSeal™ Injector Plus is a component of the ProSeal™ CSTD system intended for connection to a standard Luer lock syringe. It is one variant of the cleared ProSeal™ Injector, a component device of the ProSeal™ CSTD system. Just like the ProSeal™ Injector, a nonlatex elastomeric membrane covers the liquid transfer cannula tip of the ProSeal™ Injector Plus. It incorporates a clamp mechanism that reversibly connects to the other component devices of the ProSeal™ CSTD system. The ProSeal™ Injector Plus, like the ProSeal™ Injector includes a stainless steel cannula that is always shielded: during preparation, use and disposal. The ProSeal™ Injector Plus is supplied with a protective cap.

The provided text is a 510(k) premarket notification for a medical device called "ProSeal™ Injector Plus (Model no. 421050)". It details the device's description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML model for medical image analysis, which is what your request is about. The device is an "Intravascular Administration Set" and does not appear to involve AI.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (for an AI/ML model): This is a hardware device, not an AI/ML model.
2. Sample size used for the test set and data provenance: No AI/ML test set is described.
3. Number of experts used to establish ground truth and qualifications: No ground truth establishment for AI/ML is mentioned.
4. Adjudication method for the test set: Not applicable for a hardware device.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable for a hardware device.
6. Standalone (algorithm-only) performance: Not applicable for a hardware device.
7. Type of ground truth used: Not applicable for a hardware device.
8. Training set sample size: No AI/ML training set is mentioned.
9. How ground truth for the training set was established: No AI/ML training set is mentioned.

The document focuses on:

• Functional performance: Bench performance verifications and validations against ISO standards (e.g., fluid leakage, air leakage, stress cracking, resistance to separation, drop test, flexural force test, tensile force test, compression force test, sharps access, device leakage integrity, needle bonding strength, sharps injury protection, cap removal force).
• Biocompatibility: Conformance to ISO 10993-1, with tests like cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization.
• Sterility, Shipping, and Shelf-Life: Conformance to ISO 11135 and other standards for sterilization, endotoxin testing, accelerated aging, seal strength, and ethylene oxide residuals.

These are standard hardware device tests, not related to AI/ML performance.

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