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The Triple Lumen PFM PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. The Triple Lumen PFM PICC has a maximum recommended infusion rating of 5 ml/sec. The primary line of the Triple Lumen PFM PICC is also indicated for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter of lumen of 20 gauge or larger be used.

The Triple Lumen PFM PICC is a 6F triple lumen peripherally inserted central venous catheter designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheter is made of radiopaque polyurethane tubing are inserted peripherally. Each Triple Lumen PFM PICC has a kink resistant, reverse tapered catheter design. The Triple Lumen PFM PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The Triple Lumen PFM PICC is indicated for dwell times shorter or greater than 30 days. The Triple Lumen PFM PICC can be used for venous pressure monitoring. The Triple Lumen PFM PICC catheter assembly has 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 fully assembled Triple Lumen PFM PICC consists of an extruded triple lumen polyurethane catheter insert molded into an injection molded polyurethane hub (having integral suture tabs) that has extension leg tubing bonded to ISO standard Luer lock fittings for access attachment. The primary lumen is power injectable. The purple extension leg tubing from the hub has the words 'Power Injectable' and the gauge size printed on the tubing. The clamp ID ring on this extension states "5m/sec max' and 'Check Blood Return and Flush'. The two non-power injectable lumens are equivalent in size, but smaller than the power injectable lumen. The extension tubing legs are clear. The clamp ID ring on these extensions state "DO NOT POWER INJECT" on one side and the gauge size printed on the other. The catheter has depth indicating markings to assist in depth of insertion into the peripherally accessed vein. The device has no components made of natural rubber latex.

The provided text is a 510(k) Summary Statement for a medical device called the "Triple Lumen PFM PICC." It details the device's description, intended use, technical characteristics, and safety and performance tests. However, it does not contain the specific information required to complete all sections of your request.

Here's an breakdown of what can and cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document states: "The Triple Lumen PFM PICC met all established acceptance criteria. Verification and Validation testing conducted on the Triple Lumen PFM PICC yielded acceptable results."

However, it does not explicitly list the specific acceptance criteria or the reported performance metrics for each. It only lists the standards against which the device was tested.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the type of study described does not involve expert image interpretation.

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

This information is not applicable as the described tests are technical performance tests, not studies requiring adjudication of results from experts.

5. 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

This information is not provided and is not applicable to this type of device (a physical catheter) or the tests described.

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

This is not applicable as the device is a physical medical catheter, not an algorithm. The tests conducted were on the physical properties and performance of the catheter itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests mentioned, the "ground truth" would be established by the specified international standards and internal verification/validation protocols for medical device performance (e.g., measuring pressure, flow rates, material strength, biocompatibility, etc.). The document lists standards like ISO 10555-1, ISO 10993-1, etc., which define the methods and criteria for these types of "ground truth" measurements.

8. The sample size for the training set

This is not applicable as the device is a physical catheter, not an AI/ML algorithm. There is no "training set."

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary of available information:

The document primarily focuses on establishing "substantial equivalence" of the Triple Lumen PFM PICC to predicate devices (K083873 and K071875) by demonstrating comparable technical characteristics and meeting established medical device safety and performance standards. The "study" referenced is a series of "Safety and Performance Tests" conducted in accordance with various international standards, rather than a clinical trial or an AI/ML validation study.

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The PFM PICC is indicated for short or long term access to the central venous system. It is designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5 cc/sec. The maximum pressure of power injectors used with the PFM PICC may not exceed 300 psi.

The PFM Medical PFM PICC Catheters are designed for central venous catheterization. The PFM PICC lumen is comprised of a soft radiopaque polyurethane material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Cuff attachment to the lumen provides for tissue ingrown. Clamps are provided on the extension tubes to prevent airfluid communication. Female luer connectors provide the connection for intravenous administration. The catheters are available in 3F, 4F, 5F and 6F single lumen versions, and 4F, 5F and 6F in double lumen versions. The catheters are up to 60 cm in length with depth markings in 5 cm increments. Stylet and adaptor sideport is provided to assist in catheter insertion. The catheters can be used in the injection of contrast media. The maximum recommended infusion rate is 5 cc/sec. The maximum pressure of power injectors used with the PFM PICC catheter may not exceed 300psi. The PFM PICC product line is packaged with the necessary accessories for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique).

The PFM PICC device's acceptance criteria and performance are detailed in the provided information. Here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was assessed through in vitro testing covering various physical and chemical properties. The acceptance criteria are implicitly defined by compliance with ISO 10555-1 and 10555-3 standards, and by demonstrating safety and effectiveness comparable to a legally marketed predicate device.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "In vitro testing was performed on the PFM PICC." It does not provide specific numbers of devices or tests conducted for each characteristic.
• Data Provenance: The data is from retrospective in vitro testing. The country of origin of the data is not explicitly stated but implies testing conducted by or for PFM Medical, Inc., which is based in Oceanside, CA, USA.

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

Not applicable. The ground truth for this device's performance was established through in vitro testing against international standards (ISO 10555-1, 10555-3, and 10993) and comparison to a predicate device, not through expert human evaluation of a test set.

4. Adjudication Method (for the test set)

Not applicable. As the evaluation was based on in vitro testing against predefined standards, there was no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the testing described is effectively a standalone performance evaluation of the device itself (not an algorithm) without human-in-the-loop interaction in the context of its performance metrics. The in vitro tests measure the device's inherent physical and chemical properties.

7. The Type of Ground Truth Used

The ground truth used for the device's evaluation was:

• International Standards: Compliance with ISO 10555-1 and 10555-3 for performance, and ISO 10993 for biocompatibility.
• Predicate Device Comparison: Demonstrated safety and effectiveness by comparison to a legally marketed predicate device (MedComp PRO-LINE CT Power Injectable CVC, K053345).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (PICC catheter), not an artificial intelligence (AI) algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device submission.

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