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The LifeValve Central Venous Catheter is indicated for patient therapy requiring acute or long-term (chronic) central venous access for the infusion of medications, parenteral solutions, parenteral nutrition solutions, or blood products, and for the withdrawal of blood samples.

The LifeValve Central Venous Catheter includes a catheter and introduction components. The catheter is a percutaneous central venous catheter that incorporates a bidirectional valve assembly at the distal tip. The catheter is comprised of radiopaque silicone tubing, a molded radiopaque silicone tip with radiopaque marker band and a polvester implant cuff. It utilizes a luer lock connector and catheter Snap-Lock™ for proximal fittings. The catheter is equipped with a stylet stiffener. Each product is packaged in a sterile tray with 8 French introducer components. The family of LifeValve products includes externally communicating central venous catheters in two overall lengths, 50 and 65 cm.

The provided text describes a medical device, the "LifeValve Central Venous Catheter," and its 510(k) submission for regulatory clearance. However, the text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is a 510(k) summary and the FDA's letter of substantial equivalence. These documents focus on demonstrating that a new device is "substantially equivalent" to an already legally marketed predicate device, rather than providing detailed performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document mentions:

• Device Description: It describes the physical characteristics and components of the LifeValve Central Venous Catheter.
• Intended Use: It states the medical applications for which the catheter is designed.
• Substantial Equivalence Comparison: It asserts that the LifeValve catheter is "identical in intended use and fundamental scientific technology" and "substantially similar in configuration, dimensions, and materials" to a predicate device (Strato Medical Single Lumen Valved Catheter, K924851). It also states that "Minor configurational, dimensional, and material changes have improved device performance" and were "evaluated through risk analysis and qualified through design verification testing and biomaterial safety evaluations following established Design Control procedures."

Missing Information:

The critical information you requested, such as specific acceptance criteria, detailed study designs, sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results, is not present in the provided 510(k) summary and FDA letter. These types of detailed performance data are usually found in the full 510(k) submission or separate technical reports, not typically in the summary made publicly available.

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