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LATEX-FREE BIONECTOR is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latexfree Bionector is a Male/Female Luer, neutral displacement device. It does not displace fluid upon either connection or disconnection. Latex-free Bionector may be flushed with saline only or heparinized saline, in accordance with hospital protocol. The Latex-free Bionector is MR Conditional.

The Latex-free Bionector is a multi-purpose, closed, needle-free IV connector to be used for the purpose of sampling, injection, or continuous infusion of fluids or drugs. The Latex-free Bionector has a disinfectable membrane (disinfection must be carried out before and after use) which closes automatically when the infusion line or the syringe is disconnected.

The provided text describes a medical device, the Latex-free Bionector, and its FDA 510(k) premarket notification. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert involvement, adjudication methods), comparative effectiveness studies, standalone performance, or ground truth establishment relevant to the request.

The document primarily focuses on:

• Device Description and Intended Use: What the Latex-free Bionector is and what it's used for.
• Regulatory Classification: Its classification details and predicate device.
• Summary of Design Control Activities: Stating that biocompatibility data, performance testing, and risk assessment were conducted, demonstrating substantial equivalence to predicate devices.
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets those criteria, as this information is not present in the provided text.

The document states "Performance testing demonstrates that the device is substantially equivalent to the predicate devices," but it does not elaborate on what specific performance tests were performed, what the acceptance criteria for those tests were, or what the results of those tests were.

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