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The Dual Lumen Extended Length Catheter (dELC) is indicated for use up to 72 hours in attaining vascular venous access for use with the Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy. It is not for pediatric use. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement. It is inserted into peripheral venous circulation by way of a peel away introducer. The catheter is intended for short-term use with the Aquadex FlexFlow® and Aquadex SmartFlow® Systems in attaining vascular venous access for ultrafiltration treatment of patients with fluid overload. It has two models, 320101 and 320102, with identical hub designs but different effective (insertable) shaft lengths, 12 cm and 16 cm, to adapt to the patient's body size. The catheter has a radiopaque polyurethane shaft with two equal-sized inner lumens designed in a "double D" configuration. The shaft has a reverse-tapered design to minimize resistance to flow. Its outside diameter starts at 6F on the distal end and tapers back to 7F on the proximal end. The shaft with reinforcement provides kinking resistance and ensures consistent flow. the Catheter has female ISO 80369-compliance Luer connectors to connect with the Aquadex blood tubing set for withdrawal and infusion. Each extension tube has a clamp: blue on the blood withdrawal tube and white on the blood infusion tube. The blood is drawn up through the withdrawal lumen, which is proximal to the infusion lumen. The skived offset tip is designed to minimize blood recirculation.

The provided text is a 510(k) summary for a medical device called the "Dual Lumen Extended Length Catheter (dELC)". It describes the device, its intended use, comparison to predicate devices, and performance data submitted to support substantial equivalence.

However, the provided text DOES NOT contain information about an AI device or a software component that would require an acceptance criteria table, a study proving the device meets that criteria with details about sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The "Performance Data" section (Section VII) lists various bench tests (e.g., Dimensional Analysis, Shaft Stiffness, Flow Rate, Kink Resistance) and biocompatibility tests performed on the physical catheter. These are standard tests for a physical medical device and are not related to an AI/software component.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI device meets the acceptance criteria, as this information is not present in the provided document. The document pertains to a physical catheter, not an AI or software-based medical device.

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The SYNERGY™ CT PICC is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. The intended use has not changed from that of the predicate devices. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The SYNERGY™ CT PICC is indicated for short or long term (less than or greater than 30 days) peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec.

The SYNERGY™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each SYNERGY™ CT PICC has a kink resistant, reverse tapered catheter design. The SYNERGY™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The SYNERGY™ CT PICC is indicated for dwell times shorter or greater than 30 days. The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The SYNERGY™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen, 5 Fr and 6 Fr dual lumen and 6 Fr triple lumen. All catheters are approximately 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The provided text describes a 510(k) premarket notification for the SYNERGY™ CT PICC device. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than providing detailed standalone performance studies with specific statistical metrics against predefined acceptance criteria for novel clinical claims.

Based on the information provided, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates that "The SYNERGY™ CT PICC met all established acceptance criteria for performance testing and design verification testing." However, the specific quantitative acceptance criteria or the detailed reported device performance values related to infusion rates, pressure, or other functional aspects are not explicitly listed in the provided text in a table format.

What is mentioned as a performance characteristic is:
"The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi."
And, "All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi."

This implies that the acceptance criteria for power injection performance were to withstand 5 ml/sec and 300 psi without failure. The reported performance is that the device "met all established acceptance criteria" for this.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Verification testing was performed according to protocols based on the above-referenced vicince document recommendations and additional standards." It also states, "Performance data gathered in design verification testing demonstrated that the SYNERGY™ CT PICC is substantially equivalent to the noted predicate devices."

However, the specific sample size used for performance testing (test set) is not provided in the given text.

The data provenance is from "Health Line International Corporation," the manufacturer, which implies the testing was conducted by or for the manufacturer. The location is Centerville, Utah, USA. The data would be considered prospective in the sense that the tests were performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (expert consensus for a test set) is typically relevant for interpretative diagnostic devices or those involving subjective assessments. For a medical device like a Percutaneously Inserted Central Catheter (PICC) that focuses on mechanical and functional performance (e.g., ability to withstand pressure and flow rates), expert opinion is not usually used to establish "ground truth" for the device's technical specifications. Instead, performance is measured objectively through engineering tests.

Therefore, this information is not applicable and not provided in the text.

4. Adjudication Method for the Test Set

As explained above, adjudication methods (like 2+1, 3+1) are usually for situations requiring human interpretation or subjective assessment to establish ground truth or resolve discrepancies. For the performance testing of a PICC, where objective measurements of pressure, flow, and material integrity are key, adjudication methods are not applicable and not mentioned in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where different readers interpret cases, and the AI's impact on their performance is evaluated. For a catheter, this is not a relevant study design.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The entire 510(k) submission is dedicated to demonstrating the standalone performance of the SYNERGY™ CT PICC device itself through "performance testing and design verification testing" against established standards and predicate devices. There is no mention of an algorithm or human-in-the-loop component for this device. The device is a physical medical instrument.

7. The Type of Ground Truth Used

For the performance and design verification testing of the SYNERGY™ CT PICC, the "ground truth" is established by objective engineering measurements and adherence to recognized industry standards (e.g., ISO 11135:2007 for sterilization, ISO-10993 for biocompatibility, and FDA Guidance for Intravascular Catheters). The device's ability to withstand specific pressures and flow rates without failure constitutes its "performance ground truth" for these technical aspects.

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. It is a physical medical device (PICC catheter). Therefore, this information is not applicable and not provided.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/ML device with a training set, this information is not applicable and not provided.

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