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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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The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.

The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted pcriphcrally. Each Power-V PICC has a kink resistant, reverse tapered catheter design. The Power-V PICC is indicated for dwell times greater than 30 days. The Power-V PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 cc/sec with a maximum power injection pressure of 300 psi (scc Appendix B). The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations (scc Appendix C).

The Power-V PICC is illustrated in the drawings at the end of this section. The Power-V PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. All catheters are 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with luer lock fittings for access attachment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Power-V PICC device.

It's important to note that the provided text is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed scientific study report. As such, information regarding rigorous clinical trial design, statistical analysis, and detailed performance metrics as you might find for a novel drug or a high-risk device is largely absent. The focus of a 510(k) is to demonstrate equivalence to a legally marketed predicate device.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in the form of numerical thresholds for a specific test. Instead, it refers to the device meeting "all functional requirements and specifications" and demonstrating substantial equivalence to predicate devices. The key performance aspect mentioned is related to power injection capabilities.

The "Intended Use" section reiterates: "The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi." |
| Biocompatibility (conformance with standards). | "Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE." |
| Functional requirements and specifications. | "The Power-V met all functional requirements and specifications." (No specific details provided on these requirements.) |
| Substantial equivalence to predicate devices. | "The design, methods of manufacturing, and materials used in the Power-V device are substantially equivalent to the predicate devices." (Implies meeting similar performance as predicate devices, but no direct quantitative comparison is given). |

Study Details (Based on the provided 510(k) Summary)

The text describes engineering and biocompatibility testing rather than a clinical study in the traditional sense, especially a study involving human subjects or extensive retrospective data analysis for performance metrics beyond physical device capabilities.

1. Sample size used for the test set and the data provenance:

   • The document refers to "Power-V PICC catheter assemblies" being tested for power injection. It does not specify the number of catheter assemblies used in this test.
   • Data provenance: The testing appears to be prospective laboratory/bench testing conducted by the manufacturer (HDC Corporation) or a contracted lab. There is no mention of country of origin for the data or whether it's retrospective.
   • For biocompatibility, it states "Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE." This would involve specific biological tests on materials, not human testing or data from patients.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This concept is not applicable to the type of testing described. The "ground truth" for power injection performance or biocompatibility is established by the physical and chemical properties of the device and its behavior under controlled laboratory conditions, as measured by instruments and analyzed against engineering specifications and relevant standards. There is no involvement of clinical experts for "ground truth" similar to image interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or classification is involved, often for clinical outcomes or image reading. The tests described are objective, physical/chemical tests.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI or human interpretation, to assess reader performance. The Power-V PICC is an intravascular catheter with mechanical and biocompatibility performance as its primary focus.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No, this is not applicable. The Power-V PICC is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm's output.

6. The type of ground truth used:

   • For power injection: Engineering specifications and measurement data. The ability to withstand 5 cc/sec at 300 psi is measured directly using appropriate laboratory equipment.
   • For biocompatibility: Conformance to international standards (ISO 10993-1, GLP TRIPARTIE), which specify acceptable biological responses to materials. This involves a series of in-vitro and in-vivo tests to assess toxicity, irritation, sensitization, etc.

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • Not applicable for the reason above.

Summary of the "Study" Proving Acceptance:

The "study" in this context refers to bench testing and biocompatibility testing performed by or for HDC Corporation to demonstrate that the Power-V PICC meets its functional specifications and adheres to relevant safety standards. The core claim is not one of clinical superiority or a complex diagnostic performance, but rather that the device is substantially equivalent to existing, legally marketed predicate devices in terms of its design, materials, manufacturing, and basic functional capabilities, particularly its power injection functionality and biocompatibility. The regulatory pathway of a 510(k) relies heavily on this concept of substantial equivalence, meaning rigorous, comparative clinical trials are usually not required if equivalence can be demonstrated through non-clinical means.

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