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The SafeLine I.V. Bag Access Device is intended for multiple withdrawals of fluid from the set port of standard I.V. bags. The spike portion of the SafeLine I.V. Bag Access Device is inserted into the I.V. bag set port and the fluid is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine I.V. Bag Access Device. The fluid in the syringe can then be used for performing "I.V. pushes," to flush patient I.V. lines, or other pharmaceutical uses. The SafeLine I.V. Bag Access Device replaces the use of a traditional metal hypodermic needle to provide needlefree access to I.V. Bags. Thus, eliminating the potential for accidental needlestick injury.

The SafeLine™ I.V. Bag Access Device is an additional accessory device for use with McGaw's SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard I.V. bag spike and a spike protector. The SafeLine I.V. Bag Access Device is designed to withdraw drugs from standard size I.V. bags through a blunt plastic cannula attached to a syringe. Thus providing needlefree access of IV bags. As with all of the currently marketed SafeLine devices, the new SafeLine I.V. Bag Access Device is tinted green to signify a needle free SafeLine product.

The provided text is a 510(k) summary for a medical device (SafeLine I.V. Bag Access Device) and describes its characteristics, intended use, and comparison to a predicate device. It mentions "Functional performance testing of the subject device and comparison testing of the subject device with a standard I.V. bag spike," but it does not provide specific acceptance criteria or detailed study results.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone performance details.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on establishing substantial equivalence based on technological characteristics and general functional performance testing, not on providing the detailed statistical evidence you're asking for. In 1995, the level of detail provided in 510(k) summaries for performance studies was often much less comprehensive than what is expected today, especially for devices not involving complex algorithms or AI.

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