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These I.V. Extension Sets are intended to provide additional protection against inadvertent "needlestick" injuries to health care providers during the intravascular administration of fluids and medications. The I.V. Extension Sets provide for the entry to an intravascular administration set system without the need of a sharp needle by allowing for the penetration of a split septum injection sites or split septum Y-sites using an 11 gauge blunt plastic cannula.

The B.E.C. Safe Mate I.V. Extension Sets consist of a PVC tubing set which has a male luer (slip, fixed luer-lock, or rotating luer-lock) connector at one end intended to connect to an I.V. catheter or needle. At the distal end (or ends in the case of the bifurcated extension set or T-Connector extension set) is a female luer and/or split septum Needleless Injection Site for connection to an I.V. administration set. Extension set lengths may vary from 4" up to 36" or longer. The PVC tubing may be of standard bore (approximately 0.115" I.D.) or Minibore (approximately 0.040" I.D.) design and may be configured into a J-loop to facilitate tape fixation. Extension sets may also have one or more split septum Y-sites for the infusion of other liquid medications. Clamps (slide, clip, or roller) may also be included.

This document, K962801, describes an I.V. extension set, but it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary, which focuses on describing the device, its intended use, and its substantial equivalence to predicate devices based on materials and components.

Therefore, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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