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Amecath Peripheral Inserted Central Venous Catheter Sets are intended for use in attaining access to the central venous system for short or long-term use for venous pressure monitoring, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is indicated for multiple injections of contrast media through a power injector. The maximum pressure linetors used with the catheter may not exceed 300 psi and the flow rate may not exceed the maximum flow rate indicated.

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This document (K152819) is a 510(k) premarket notification for a medical device called "Amecath Peripheral Inserted Central Venous Catheter Sets." It is a regulatory clearance letter and does not contain details of a study with acceptance criteria and reported device performance related to an AI/Software as a Medical Device (SaMD) product.

The content describes the device's indications for use and confirms its substantial equivalence to legally marketed predicate devices, allowing its commercialization. There is no information provided about:

• Acceptance criteria for performance metrics
• Reported device performance against such criteria
• Sample sizes for test or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type or establishment of ground truth

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document is for a physical medical device (catheter sets), not a software or AI product that would typically involve the detailed study characteristics you've requested.

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