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The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.

The SmartPort* device with ENDEXO and Vortex Technology and the SmartPort Plastic device with Vortex Technology are implantable venous access devices designed for repeated access to the vascular system. The SmartPort* and SmartPort Plastic devices are subcutaneous implant devices with one reservoir. The ports are accessed using a Huber needle which is passed through the self-sealing silicone septum covering the reservoir. When used with power injectable needles, the port can be used for power injection of contrast media and contrast enhanced computed tomography (CECT).

Available in plastic and titanium port bodies, the SmartPort* device has standard, low profile, and mini Titanium port configurations and low-profile Plastic port configurations. The ports are offered with a 5F, 6F or 8F single lumen BioFlo catheter. The BioFlo catheter with ENDEXO technology is present in the previously cleared NMI Port II (K131694) for improved resistance to thrombus accumulation and/or formation on the catheter. The outlet of the vortex port chamber is set at a tangent rather than perpendicularly.

The SmartPort Plastic device is offered in a low-profile Plastic port body configuration with a 6F or 8F single lumen polyurethane catheter. Both the BioFlo and polyurethane catheters are radiopague.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate setting is 5 ml/s with 19G or 20G non-coring power injectable needles or 2 ml/s with a 22G non-coring power injectable needle.

The ports are available with either silicone filled suture fixation holes. If desired, the suture fixation holes can be used to anchor the port to the subcutaneous tissue. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter is marked at every centimeter and can be cut to the desired length.

The ports are packaged with procedural accessories in a kit to the end user

The provided text does not contain information about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device. Instead, it is a 510(k) premarket notification for implantable infusion ports (SmartPort+ and SmartPort Plastic Implantable Ports), which are physical medical devices, not AI/ML software. Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from this document.

The document details non-clinical performance testing for the physical device, including:

• Multiple Power Injections
• Port Septum Testing
• Chemical / Vesicant Compatibility
• Nuclear Medicine Compatibility
• Off-Axial Connection
• Power Injection Flow Rate
• Assembly Leak Strength
• Static Burst Strength
• Port Maximum Operating Pressure, Dynamic
• Catheter Kink Resistance
• Catheter Flex Life Strength
• Catheter Freedom from Leakage
• Catheter Burst Strength
• Catheter Peak Tensile Force
• Catheter Radiopacity
• Catheter Distance Marking
• Catheter Print Integrity
• Catheter Tip Dimensions
• Aspiration Strength Open Ended
• Aspiration Strength Closed Ended
• Tunneler to Catheter Compatibility
• 17G Blunt Needle to Catheter Compatibility
• Guidewire to Catheter Compatibility
• Introducer to Catheter Compatibility
• Gravity Flow Rate
• Distribution Simulation
• Surface Finish
• Hyperbaric Chamber Environment

It also includes a biocompatibility assessment and sterilization validation. However, these are for the physical properties and biological interaction of the implantable port, not for an AI/ML algorithm's performance.

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