(130 days)
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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”