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Tamper Evident Cap For use with ENFit® Syringes is indicated for use to prevent fluid loss and contamination of syringe contents until ready for use with evidence of access.

Tamper Evident Cap For use with ENFit® Syringes is a sterile, single use disposable device for use as a closure cap with evidence of access for Enteral Syringes with ENFit™ Connectors. Removal of the cap is achieved by removing a restrictive sleeve covering the ENFit™ Lock Cap. A damaged or missing restrictive sleeve indicates potential tampering. A non-sterile version of the device is also offered.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Tamper Evident Cap For use with ENFit® Syringes) and focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the document lists various performance bench tests that were conducted (Liquid Leakage, Stress Cracking, Resistance to Separation from Axial Load, etc., as per AAMI/ISO 80369-3, and additional internal specifications like Visual Indication of Tamper Evidence). However, it does not provide specific acceptance criteria values or the reported performance data in a tabular format as requested. It only states that the device "meets the bench testing requirements" and "passed all biocompatibility tests."

Therefore, I cannot populate the requested table or provide details on sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information.

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