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Sherlock 3CG™ Tip Positioning System Sensor: The Sherlock 3CG™ Tip Positioning System (TPS) is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG™ TPS provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.

Sherlock 3CG™ Tip Positioning System Stylet: Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG™ Tip Positioning System (TPS), the Sherlock 3CG™ TPS stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

The Sherlock 3CG™ Tip Positioning System (TPS) consists of a sensor, stylet, and connection assembly. The system is designed to aid in central venous catheter tip positioning through magnet tracking and ECG signal information. The Sherlock 3CG™ TPS System detects and displays the position of the magnet-tipped stylet relative to the sensor. In addition, the Sherlock 3CG™ TPS System detects and displays a cardiac electrical signal from the three ECG electrodes, including the Sherlock 3CG™ TPS Stylet and two body electrodes, which provide catheter tip positioning information.

The provided document is a 510(k) summary for the Sherlock 3CG™ Tip Positioning System. However, it does not contain specific acceptance criteria or a study demonstrating that the device meets such criteria.

The document states:

• "Performance standards have not been established by the FDA under §514 of the Federal Food, Drug and Cosmetic Act."
• "Verification and validation tests have been performed in accordance with Design Controls per 21 CFR §820.30."
• "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Sherlock 3CG™ TPS System... met the minimum requirements that are considered adequate for its intended use and are substantially equivalent in design, materials, sterilization, principles of operation and indications for use to the current commercially available Sherlock™ II Tip Location System... and the FlowPICC™ System..."

This indicates that while safety and performance testing was conducted, the detailed results, acceptance criteria, or a specific study designed to prove these criteria were met are not provided in the given text. The primary argument for clearance is substantial equivalence to predicate devices, rather than meeting specific quantitive performance standards.

Therefore, I cannot provide the requested information from the given text as it is not present.

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