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THE R4 VASCULAR INC. PEGASUS CT PICC IS INDICATED FOR SHORT TERM AND LONG-TERM PERIPHERAL ACCESS TO THE CENTRAL VENOUS SYSTEM FOR INTRAVENOUS THERAPY AND POWER INJECTION OF CONTRAST MEDIA. FOR BLOOD SAMPLING, INFUSION, OR THERAPIES, USE A 4F OR LARGER CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 5F AND 6F PEGASUS CT PICC CATHETER MAY NOT EXCEED 300PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 5CC/SEC FOR 5F AND 6F CATHETER. THE MAXIMUM PRESSURE OF INJECTORS USED WITH THE 4F PEGASUS CT PICC CATHETER MAY NOT EXCEED 200PSI. MAXIMUM RECOMMENDED INFUSION RATE IS 4CC/SEC FOR A 4F CATHETER.

• The Pegasus CT PICC catheters are radiopaque polyurethane.
• Catheter usable length is 55 to 60 cm in length. It is available in a 4F/5F single lumen and 5F/6F dual lumen version.
• The catheter has a reverse taper design.
• Catheter lumen tubing is marked with depth markings for proper placement of the catheter during insertion.
• Catheters are provided sterile in basic radiology and nursing PICC configurations.
• The catheter has one power injectable lumen.
• Purple colorant was added to the catheter materials to distinguish it from other nono power injectable catheters and recognize it as a power injectable catheter.
• The catheter extension, ID rings are printed to identify the catheter as a Power Injectable Catheter to ensure proper use of the device.

The provided text describes the 510(k) summary for the r4 Vascular Inc. Pegasus CT PICC. It states that clinical studies were not considered necessary, because the device's substantial equivalence to a predicate device (Medcomp Pro-Line CT Power Injectable CVC Catheter, K053345) was demonstrated through in vitro testing. Therefore, there is no explicit study described that proves the device meets specific acceptance criteria as would be found in a clinical trial.

However, the document does list the standards and guidelines followed for verification and validation testing, implying that these standards contain the acceptance criteria for device performance. Since no direct performance values are given from such tests in the provided text, I will describe the type of acceptance criteria implied by the cited standards and the reported device characteristics that are intended to meet these criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Pegasus CT PICC are implied by the conformance to the listed international and AAMI/ANSI/ISO standards. These standards typically set requirements for:

• Sterility: Ensuring the device is free from viable microorganisms.
• Biocompatibility: Ensuring the materials used are safe for contact with the human body.
• Physical and Chemical Properties: Requirements related to material strength, durability, patency, flow rates, and pressure limits under specified conditions.
• Labeling Accuracy: Ensuring critical information like power injection limits, catheter size, and intended use is clearly marked.

Since the submission relies on substantial equivalence to a predicate device and states that "The technological characteristics such as design and materials are identical to the predicate device," the reported performance is essentially that it meets the requirements of the predicate and the general standards.

No information regarding clinical study design elements like sample size, data provenance, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance is present, as no clinical studies were deemed necessary.

Here's why based on the document:

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used for a human-centric study. In vitro testing was performed. The data provenance for the materials is that they were "previously cleared for similar applications."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established through in vitro testing against standards, not expert consensus on human data.
3. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical catheter, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is compliance with international and AAMI/ANSI/ISO standards (e.g., ISO 10555, ISO 10993, AAMI/ANSI/ISO 11135), established through in vitro testing.
7. The sample size for the training set: Not applicable. This device is a medical catheter and was not developed using machine learning.
8. How the ground truth for the training set was established: Not applicable. This device is a medical catheter and was not developed using machine learning.

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