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The CONTIPLEX® Stim Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and/or analgesics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The Contiplex catheter can be used for up to 72 hours.

The CONTIPLEX® Stim Continuous Nerve Block Set is a kit that contains a stimulating catheter with a plastic dispensing coil, tuohy needle, sideport valve assembly, catheter connector, ChloraPrep One-Step, 3 mL Applicator and a Tegaderm Transparent Dressing. The catheter is electrically conductive and is composed of an inner metal coil and outer polyamide layer. The catheter is radiopaque and is contained in a plastic dispensing coil with an electrical connector attached to a stylet. The tuohy needle is insulated and has an attached integrated wire. The sideport valve assembly is used in the procedure to attach to the tuohy needle and a syringe containing the anesthetic solution. The Chloraprep (Mediflex) is used to prep the patient's skin prior to the procedure and the Tegaderm (3M) is a dressing.

The CONTIPLEX Stim Continuous Nerve Block Set is intended for use with B. Braun Stimuplex HNS 11, Stimuplex HNS 12, and Stimuplex Dig RC nerve stimulators. When used with the Stimuplex HNS 11 and Stimuplex HNS 12 nerve stimulators, the Stimuplex Switch may be used. When used with the Stimuplex Dig RC nerve stimulator, the Stimuplex Switch can not be used.

The provided 510(k) summary for the Contiplex® Stim Continuous Nerve Block Set (K063282) does not contain the information required to populate the acceptance criteria and study details as requested.

This 510(k) relies on substantial equivalence to predicate devices, which means it demonstrates that the new device is as safe and effective as a legally marketed device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics of the device itself.

The document mentions "functional performance testing to support that it functions as intended" and "biocompatibility testing to support the safety of the materials," but it does not provide specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or details about expert involvement for any performance studies.

Therefore, I cannot provide the requested table and study details.

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